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Completed

NCT Number: NCT04922840

Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases

Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint inflammation, pain, stiffness and fatigue. Compared to the general population, this large patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related mortality. Patients with IJD call for improved CVD screening and risk management as well as access to evidence-based non-pharmacological treatment alternatives. Evidence supports high intensity training (HIIT) in mitigating risk of CVD and inflammation, but the evidence of these cardioprotective benefits is unclear in patients with IJD and the feasibility of HIIT protocols in daily clinical care needs to be addressed. Cardiorespiratory fitness (CRF) is an important physiological marker and highly correlated to risk of CVD. Despite strong recommendations, routine assessment of CRF is seldom performed in clinical care.

The ExeHeart study will assess the potential cardioprotective and disease-modifying effect of HIIT in IJD in a randomized controlled trial. Furthermore, the ExeHeart-study will report on the validity of non-exercise measures of cardiorespiratory fitness (eCRF) measures for use in daily clinical care. Additionally, we will explore the feasibility of HIIT by addressing adherence and fidelity to the HIIT treatment protocol in a primary care setting

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Key information

Conditions

Spondyloarthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Behavior Bone Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital

Oslo, Norway

About this study

The study is a two-armed randomized controlled trial (RCT). Patients aged 18-70 years presenting with inflammatory joint disease at the Preventive Cardio-Rheuma clinic at Diakonhjemmet hospital (Oslo) will be included if eligible for the study. Succeeding baseline testing, participants are randomized to either experimental group (high-intensity exercise-HIIT) or control group (usual care).

The research questions are:

  • Is a 12-week HIIT program effective on VO2peak, inflammatory markers and risk of cardiovascular disease in patients with inflammatory joint disease and what is the association between VO2peak and disease-specific and cardiovascular disease-related variables?
  • Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining longitudinal change in VO2peak in patients with inflammatory joint disease?
  • How feasible is a HIIT intervention in primary care in patients with inflammatory joint disease in terms of adherence and fidelity to the exercise program?

The primary analysis will be a between group comparison of VO2peak levels. This will be carried out according to the intention-to-treat principle, and done by the analysis of covariance (ANCOVA), adjusting for VO2peak values at baseline along with stratification factors used in the randomization. Secondary analyses will include between group comparisons on secondary endpoints, as well as comparisons in the per protocol population. No adjustment for multiple testing will be done.

The association between VO2peak and changes in inflammatory markers, disease activity and CVD risk will be assessed using multiple regression.

The validity of eCRF models to accurately detect longitudinal change in VO2peak from baseline to 3-month and 6-month follow-up will be assessed with Pearson or Spearman correlation by comparing VO2peak derived from a cardiopulmonary exercise test to eCRF.

The feasibility of a HIIT program and adherence will be examined with descriptive statistics. Adherence to the prescribed HIIT intervention will be recorded by attendance to exercise sessions. Quality of treatment delivery will be quantified as the number of exercise sessions complying with the planned exercise intensity and number of exercise sessions requiring dose modifications such as lower exercise intensity or early session termination. At the 3-month timepoint, an electronic questionnaire will be distributed to patients in the HIIT group. Questions regarding feasibility and implementation fidelity will address patients' acceptability and satisfaction with the HIIT program. The ExeHeart study will also include semi-structured interviews, targeting physiotherapists in charge of supervising the exercise sessions and 5-7 patients in the intervention group. The interviews will explore barriers and facilitators in exercise adherence, experience with the protocol and perceived effects of exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-70
  • BMI: 18.5-40
  • Inflammatory joint disease verified by physician
  • Able to walk unaided and continuously for ≥ 15 min.
  • Norwegian or English speaking

Exclusion criteria

  • Sustained lower extremity injury ≤12 months, including surgery
  • Neurological disease
  • Absolute contraindication to maximal exercise test
  • Cognitive impairment
  • Participation in structured high-intensity exercise ≥ 1/week in the last 3 months

Treatment and study plan

High-intensity exercise (HIIT)

Behavioral

12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.

Primary outcomes

  1. Peak oxygen uptake - VO2peak ml/kg/min

    Time frame: 3 months post baseline

    VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

Secondary outcomes

  1. Peak oxygen uptake - VO2peak L/min

    Time frame: 3 months post baseline

    VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

  2. Peak oxygen uptake - VO2peak ml/kg/min

    Time frame: Baseline

    VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)

  3. Peak oxygen uptake - VO2peak ml/kg/min

    Time frame: 6 months post baseline

    VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)

  4. Peak oxygen uptake - VO2peak L/min

    Time frame: Baseline

    VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)

  5. Peak oxygen uptake - VO2peak L/min

    Time frame: 6 months post baseline

    VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)

  6. Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline

    Time frame: 3 months post baseline

    Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

  7. Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline

    Time frame: 6 months

    Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

  8. Change in VO2peak L/min from baseline to 3 months post baseline

    Time frame: 3 months post baseline

    VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

  9. Change in VO2peak L/min from baseline to 6 months post baseline

    Time frame: 6 months post baseline

    VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

  10. Body composition

    Time frame: Baseline

    Body scan to estimate total and regional distribution of lean body mass and fat mass

  11. Body composition

    Time frame: 3 months post baseline

    Body scan to estimate total and regional distribution of lean body mass and fat mass

  12. Body composition

    Time frame: 6 months post baseline

    Body scan to estimate total and regional distribution of lean body mass and fat mass

  13. Ventilatory threshold 1

    Time frame: Baseline

    Point during at which ventilation starts to increase at a faster rate than VO2 - derived from CPET

  14. Ventilatory threshold 1

    Time frame: 3 months post baseline

    Point during exercise at which ventilation starts to increase at a faster rate than VO2 - derived from CPET

  15. Ventilatory threshold 1

    Time frame: 6 months post baseline

    Point during exercise at which ventilation starts to increase at a faster rate than volume of oxygen (VO2) - derived from CPET

  16. Ventilatory threshold 2

    Time frame: Baseline

    The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET

  17. Ventilatory threshold 2

    Time frame: 3 months post baseline

    The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET

  18. Ventilatory threshold 2

    Time frame: 6 months post baseline

    The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET

  19. Breathing reserve

    Time frame: Baseline

    Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET

  20. Breathing reserve

    Time frame: 3 months post baseline

    Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET

  21. Breathing reserve

    Time frame: 6 months post baseline

    Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET

  22. Oxygen pulse

    Time frame: Baseline

    The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.

  23. Oxygen pulse

    Time frame: 3 months post baseline

    The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.

  24. Oxygen pulse

    Time frame: 6 months post baseline

    The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.

  25. Ventilatory equivalents for oxygen (VE/VO2)

    Time frame: Baseline

    Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET

  26. Ventilatory equivalents for oxygen (VE/VO2)

    Time frame: 3 months post baseline

    Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET

  27. Ventilatory equivalents for oxygen (VE/VO2)

    Time frame: 6 months post baseline

    Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET

  28. Ventilatory equivalents for carbon dioxide(VE/VCO2)

    Time frame: Baseline

    Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET

  29. Ventilatory equivalents for carbon dioxide(VE/VCO2)

    Time frame: 3 months post baseline

    Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET

  30. Ventilatory equivalents for carbon dioxide (VE/VCO2)

    Time frame: 6 months post baseline

    Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET

  31. Respiratory Exchange Ratio (RER)

    Time frame: Baseline

    Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET

  32. Respiratory Exchange Ratio (RER)

    Time frame: 3 months post baseline

    Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET

  33. Respiratory Exchange Ratio (RER)

    Time frame: 6 months post baseline

    Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET

  34. Blood lactate concentration

    Time frame: Baseline

    Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes

  35. Blood lactate concentration

    Time frame: 3 months post baseline

    Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes

  36. Blood lactate concentration

    Time frame: 6 months post baseline

    Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes

  37. C-Reactive protein

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein

  38. C-Reactive protein

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein

  39. C-Reactive protein

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein

  40. Erythrocyte Sedimentation Rate

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate

  41. Erythrocyte Sedimentation Rate

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate

  42. Erythrocyte Sedimentation Rate

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate

  43. Total cholesterol

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol

  44. Total cholesterol

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol

  45. Total cholesterol

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol

  46. High-density lipoproteins

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins

  47. High-density lipoproteins

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins

  48. High-density lipoproteins

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins

  49. Low-density lipoproteins

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins

  50. Low-density lipoproteins

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins

  51. Low-density lipoproteins

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins

  52. Triglycerides

    Time frame: Baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides

  53. Triglycerides

    Time frame: 3 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides

  54. Triglycerides

    Time frame: 6 months post baseline

    Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides

  55. Blood pressure

    Time frame: Baseline

    Supine systolic and diastolic blood pressure

  56. Blood pressure

    Time frame: 3 months post baseline

    Supine systolic and diastolic blood pressure

  57. Blood pressure

    Time frame: 6 months post baseline

    Supine systolic and diastolic blood pressure

  58. Body Mass Index

    Time frame: Baseline

    Weight in kilograms divided by the square of height in meters

  59. Body Mass Index

    Time frame: 3 months post baseline

    Weight in kilograms divided by the square of height in meters

  60. Body Mass Index

    Time frame: 6 months post baseline

    Weight in kilograms divided by the square of height in meters

  61. Waist circumference

    Time frame: Baseline

    Waist girth in centimeters. Measured in a standing position after a full exhale.

  62. Waist circumference

    Time frame: 3 months post baseline

    Waist girth in centimeters. Measured in a standing position after a full exhale.

  63. Waist circumference

    Time frame: 6 months post baseline

    Waist girth in centimeters. Measured in a standing position after a full exhale.

  64. Resting heart rate

    Time frame: Baseline

    Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench

  65. Resting heart rate

    Time frame: 3 months post baseline

    Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench

  66. Resting heart rate

    Time frame: 6 months post baseline

    Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench

  67. Health-related quality of life, EuroQoL (EQ5D-5L)

    Time frame: Baseline

    Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.

  68. Health-related quality of life, EuroQoL (EQ5D-5L)

    Time frame: 3 months post baseline

    Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.

  69. Health-related quality of life, EuroQoL (EQ5D-5L)

    Time frame: 6 months post baseline

    Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.

  70. Frequency of medication

    Time frame: Baseline

    Usage of medications last three months. Measured in frequency.

  71. Dosage of medication

    Time frame: Baseline

    Usage of medications last three months. Measured in dosage.

  72. Dosage of medication

    Time frame: 3 months post baseline

    Usage of medications last three months. Measured in dosage

  73. Frequency of medication

    Time frame: 3 months post baseline

    Usage of medications last three months. Measured in frequency

  74. Dosage of medication

    Time frame: 6 months post baseline

    Usage of medications last three months. Measured in dosage.

  75. Frequency of medication

    Time frame: 6 months post baseline

    Usage of medications last three months. Measured in frequency.

  76. Self-reported fatigue

    Time frame: Baseline

    Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).

  77. Self-reported fatigue

    Time frame: 3 months post baseline

    Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).

  78. Self-reported fatigue

    Time frame: 6 months post baseline

    Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).

  79. Self-reported pain

    Time frame: Baseline

    Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).

  80. Self-reported pain

    Time frame: 3 months post baseline

    Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).

  81. Self-reported pain

    Time frame: 6 months post baseline

    Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).

  82. Self-reported physical activity (HUNT)

    Time frame: Baseline

    Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.

  83. Self-reported physical activity (HUNT)

    Time frame: 3 months post baseline

    Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.

  84. Self-reported physical activity (HUNT)

    Time frame: 6 months post baseline

    Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.

  85. SCORE2

    Time frame: Baseline

    Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.

  86. SCORE2

    Time frame: 3 months post baseline

    Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.

  87. SCORE2

    Time frame: 6 months post baseline

    Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.

  88. Forced vital capacity

    Time frame: Baseline

    Volume of air that can be forcefully exhaled after a full inspiration, measured in liters. Obtained from spirometry

  89. Forced vital capacity

    Time frame: 3 months post baseline

    Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry

  90. Forced vital capacity

    Time frame: 6 months post baseline

    Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry

  91. Forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline

    Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry

  92. Forced expiratory volume in 1 second (FEV1)

    Time frame: 3 months post baseline

    Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry

  93. Forced expiratory volume in 1 second (FEV1)

    Time frame: 6 months post baseline

    Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry

  94. FEV1/FVC ratio

    Time frame: Baseline

    Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)

  95. FEV1/FVC ratio

    Time frame: 3 months post baseline

    Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)

  96. FEV1/FVC ratio

    Time frame: 6 months post baseline

    Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)

  97. Forced expiratory flow

    Time frame: Baseline

    Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry

  98. Forced expiratory flow

    Time frame: 3 months post baseline

    Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry

  99. Forced expiratory flow

    Time frame: 6 months post baseline

    Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry

  100. Peak expiratory flow (PEF)

    Time frame: Baseline

    Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry

  101. Peak expiratory flow (PEF)

    Time frame: 3 months post baseline

    Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry

  102. Peak expiratory flow (PEF)

    Time frame: 6 months post baseline

    Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry

  103. Maximum voluntary ventilation (MVV)

    Time frame: Baseline

    Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry

  104. Maximum voluntary ventilation (MVV)

    Time frame: 3 months post baseline

    Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry

  105. Maximum voluntary ventilation (MVV)

    Time frame: 6 months post baseline

    Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry

  106. Psoriatic Arthritis Impact of Disease (PsAID)

    Time frame: Baseline

    Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.

  107. Psoriatic Arthritis Impact of Disease (PsAID)

    Time frame: 3 months post baseline

    Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants psoriatic arthritis.

  108. Psoriatic Arthritis Impact of Disease (PsAID)

    Time frame: 6 months post baseline

    Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.

  109. Rheumatoid arthritis impact of disease (RAID)

    Time frame: Baseline

    Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.

  110. Rheumatoid arthritis impact of disease (RAID)

    Time frame: 3 months post baseline

    Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.

  111. Rheumatoid arthritis impact of disease (RAID)

    Time frame: 6 months post baseline

    Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.

  112. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  113. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 3 months post baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  114. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 6 months post baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  115. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Baseline

    Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  116. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: 3 months post baseline

    Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  117. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: 6 months post baseline

    Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  118. Bath Ankylosing Spondylitis Global Score (BAS-G)

    Time frame: Baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  119. Bath Ankylosing Spondylitis Global Score (BAS-G)

    Time frame: 3 months post baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  120. Bath Ankylosing Spondylitis Global Score (BAS-G)

    Time frame: 6 months post baseline

    Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.

  121. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 3 months post baseline

    Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.

  122. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 6 months post baseline

    Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.

  123. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: Baseline

    Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.

  124. Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)

    Time frame: Baseline

    Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.

  125. Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)

    Time frame: 3 months post baseline

    Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.

  126. Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)

    Time frame: 6 months post baseline

    Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.

  127. Disease Activity in PSoriatic Arthritis (DAPSA)

    Time frame: Baseline

    Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis

  128. Disease Activity in PSoriatic Arthritis (DAPSA)

    Time frame: 3 months post baseline

    Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis

  129. Disease Activity in PSoriatic Arthritis (DAPSA)

    Time frame: 6 months post baseline

    Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis

  130. Post-exercise questionnaire

    Time frame: 3 months post baseline

    Electronic questionnaire distributed to patients in the experimental group upon completion of HIT intervention. 14 statements related to participation in the HIT exercise intervention and perceived intensity, duration and frequency of the exercise intervention. Scored on a 5 point Likert scale ranging from strongly disagree to strongly agree.

  131. Use of healthcare services

    Time frame: Baseline

    Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.

  132. Use of healthcare services

    Time frame: 3 months post baseline

    Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.

  133. Use of healthcare services

    Time frame: 6 months post baseline

    Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.

  134. Smoking status

    Time frame: Baseline

    Registered by self-report; I smoke daily, I am a former smoker , I have never smoked

  135. Smoking status

    Time frame: 3 months post baseline

    Registered by self-report; I smoke daily, I am a former smoker , I have never smoked

  136. Smoking status

    Time frame: 6 months post baseline

    Registered by self-report; I smoke daily, I am a former smoker , I have never smoked

  137. Snuff status

    Time frame: Baseline

    Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff

  138. Snuff status

    Time frame: 3 months post baseline

    Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff

  139. Snuff status

    Time frame: 6 months post baseline

    Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff

  140. Peak heart rate

    Time frame: Baseline

    Peak heart rate observed during CPET

  141. Peak heart rate

    Time frame: 3 months post baseline

    Peak heart rate observed during CPET

  142. Peak heart rate

    Time frame: 6 months post baseline

    Peak heart rate observed during CPET

  143. Augmentation index

    Time frame: Baseline

    Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure

  144. Augmentation index

    Time frame: 3 months post baseline

    Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure

  145. Augmentation index

    Time frame: 6 months post baseline

    Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure

  146. Pulse Wave Velocity

    Time frame: Baseline

    Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure

  147. Pulse Wave Velocity

    Time frame: 3 months post baseline

    Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure

  148. Pulse Wave Velocity

    Time frame: 6 months post baseline

    Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure

  149. Exercise self-efficacy

    Time frame: Baseline

    Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.

  150. Exercise self-efficacy

    Time frame: 3 months post baseline

    Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.

  151. Exercise self-efficacy

    Time frame: 6 months post baseline

    Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.

  152. Exercise frequency

    Time frame: 3 months post baseline

    Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise frequency is recorded.

  153. Exercise intensity

    Time frame: 3 months post baseline

    Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise intensity is recorded by use of a herat rate monitor.

  154. Exercise duration

    Time frame: 3 months post baseline

    Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise duration is recorded.

  155. Early session termination

    Time frame: 3 months post baseline

    Participants in the experimental group are asked to record individual exercise session in a training diary. Early session termination is recorded.

  156. Exercise-related adverse events

    Time frame: 3 months post baseline

    Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise-related adverse events are recorded.

  157. Self-reported cardiovascular health and symptoms

    Time frame: Baseline

    13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided

  158. Self-reported cardiovascular health and symptoms

    Time frame: 3 months post baseline

    13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided

  159. Self-reported cardiovascular health and symptoms

    Time frame: 6 months post baseline

    13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided

  160. Self-report change in physical fitness

    Time frame: 3 months post baseline

    Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse

  161. Self-report change in physical fitness

    Time frame: 6 months post baseline

    Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse

  162. Self-report exercise habits

    Time frame: 3 months post baseline

    Questionnaire; self-report of exercise habits from baseline to 3 months post baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other).

    These questions are only forwarded to participants in the control group at this timepoint. Exercise habits form baseline to 3 months post baseline is recorded via the training diary for participants allocated to HIIT (experimental group): see outcome 153-157.

  163. Self-report exercise habits

    Time frame: 6 months post baseline

    Questionnaire; self-report of exercise habits from 3 months post baseline to 6 months post-baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other).

    These questions are forwarded to all study participants at this timepoint.

  164. Corona virus 19 infection

    Time frame: 3 months post baseline

    Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from baseline to 3 months post baseline

  165. Corona virus 19 infection

    Time frame: 6 months post baseline

    Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from 3 months post baseline to 6 montsh post baseline

  166. Corona virus 19 quarantine

    Time frame: 3 months post baseline

    Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from baseline to 3 months post baseline

  167. Corona virus 19 quarantine

    Time frame: 6 months post baseline

    Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from 3 months post baseline to 6 months post baseline

  168. Maximum minute ventilation at peak exercise (VEmax, L/min)

    Time frame: Baseline

    Maximum ventilation, recorded from CPET at peak exercise

  169. Maximum minute ventilation at peak exercise (VEmax, L/min)

    Time frame: 3 months post baseline

    Maximum ventilation, recorded from CPET at peak exercise

  170. Maximum minute ventilation at peak exercise (VEmax, L/min)

    Time frame: 6 months post baseline

    Maximum ventilation, recorded from CPET at peak exercise

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • Norwegian Health Association
  • The Dam Foundation
  • The Norwegian Rheumatism Association

Registry information

Acronym: ExeHeart

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 11, 2021
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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