Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05768165

High-intensity Interval Exercise in Rheumatoid Arthritis

Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska university hospital, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria
  • Disease duration >1 year
  • Age (range 20-60 years)
  • Stable medication on anti- rheumatic drugs for >3 months
  • Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28)

Exclusion criteria

  • Cerebrovascular diseases
  • Diabetes
  • Severe hypertension
  • Chronic obstructive pulmonary disease or other severe pulmonary diseases
  • Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise
  • Arthroplasty of large joints
  • Inability to manage Cardiopulmonary Exercise Testing (CPET)
  • Pregnancy
  • Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months
  • Inability to speak or read Swedish.

Treatment and study plan

High intensity exercise

Behavioral

Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets.

Exercise guidance follows principles of self-efficacy and person-centeredness.

Other names: Person- centeredness

Primary outcomes

  1. Cardiopulmonary function

    Time frame: 0 -12 weeks

    Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)

Secondary outcomes

  1. Vascular function

    Time frame: 0-12 weeks

    Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)

  2. Level of disease activity

    Time frame: 0-12 weeks

    Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)

  3. Level of disease activity

    Time frame: 0-6 months

    Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)

  4. Level of disease activity

    Time frame: 0-12 months

    Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)

  5. Homeostatic model assessment of insulin resistance (HOMA IR)

    Time frame: 0-12 weeks

    Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR

  6. Glycosylation level of hemoglobin (HbA1c)

    Time frame: 0-12 weeks

    Glycosylation level of hemoglobin (mmol/mol)

  7. Level of blood lipids

    Time frame: 0-12 weeks

    Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )

  8. Erythrocyte Sedimentation Rate (ESR)

    Time frame: 0-12 weeks

    Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)

  9. Erythrocyte Sedimentation Rate (ESR)

    Time frame: 0-6 months

    Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)

  10. Erythrocyte Sedimentation Rate (ESR)

    Time frame: 0-12 months

    Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)

  11. C-Reactive Protein (CRP)

    Time frame: 0-12 weeks

    Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)

  12. C-Reactive Protein (CRP)

    Time frame: 0-6 months

    Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)

  13. C-Reactive Protein (CRP)

    Time frame: 0-12 months

    Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)

  14. Cytokine levels

    Time frame: 0-12 weeks

    Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)

  15. Muscle function of lower extremities

    Time frame: 0-12 weeks

    The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)

  16. Hand-grip force

    Time frame: 0-12 weeks

    Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)

  17. Self-reported physical activity

    Time frame: 0-12 weeks

    Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)

  18. Self-reported physical activity

    Time frame: 0-6 months

    Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)

  19. Self-reported physical activity

    Time frame: 0-12 months

    Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)

  20. Objective assessment of physical activity

    Time frame: 0-12 weeks

    Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)

  21. Objective assessment of physical activity

    Time frame: 0-6 months

    Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)

  22. Objective assessment of physical activity

    Time frame: 0-12 months

    Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)

  23. Pain intensity

    Time frame: 0-12 weeks

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)

  24. Pain intensity

    Time frame: 0-6 months

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)

  25. Pain intensity

    Time frame: 0-12 months

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)

  26. Global health

    Time frame: 0-12 weeks

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)

  27. Global health

    Time frame: 0-6 months

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)

  28. Global health

    Time frame: 0-12 months

    Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)

  29. Fatigue

    Time frame: 0-12 weeks

    The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue

  30. Fatigue

    Time frame: 0-6 months

    The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue

  31. Fatigue

    Time frame: 0-12 months

    The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue

  32. Sleep

    Time frame: 0-12 weeks

    Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).

  33. Sleep

    Time frame: 0-6 months

    Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).

  34. Sleep

    Time frame: 0-12 months

    Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).

  35. Activity limitations

    Time frame: 0-12 weeks

    Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)

  36. Activity limitations

    Time frame: 0-6 months

    Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)

  37. Activity limitations

    Time frame: 0-12 months

    Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)

  38. Attitude to exercise

    Time frame: 0-12 weeks

    Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.

  39. Attitude to exercise

    Time frame: 0-6 moths

    Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.

  40. Attitude to exercise

    Time frame: 0-12 months

    Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.

  41. Body compositions

    Time frame: 0-12 weeks

    Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)

  42. Waist circumference

    Time frame: 0-12 weeks

    Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis

Acronym: RA-HIIT

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Dec 22, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.