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NCT Number: NCT06166199

Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus

The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Behavior Behavioral Symptoms Connective Tissue Diseases Depression Fatigue Immune System Diseases Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The overall aim of this randomized controlled study, is to evaluate the safety and effects of HIIT combined with resistance exercises on aerobic capacity, muscle function, patient reported outcomes, disease activity and immune function in patients with SLE with low to moderate disease activity and no to little organ damage. The aim is also to explore and describe patient's experiences of the training.

The research questions are:

  • What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding aerobic capacity, muscle function, physician and patient reported disease activity, fatigue, depressive symptoms, and quality of life?
  • What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding inflammatory markers such as interleukin 6 and 10 and interferon molecules? Both acute exercise test (maximal ergometercycle test) effects as well as the long term effects of training will be evaluated.
  • How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years old
  • Fulfilment of the 1982 American College of Rheumatology (ACR) criteria; or 2012 Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index (DI)) classification criteria; or EULAR/ACR criteria; or patients that have received the diagnosis SLE on clinical grounds
  • Low to moderate disease activity, for example defined as a score of ≤5 in the clinical version of the SLE Disease Activity Index 2000 (SLEDAI-2K), i.e., excluding the serological descriptors (anti-dsDNA positivity and low complement levels)
  • Low/minimal or no organ damage, for example defined as a score of ≤3 in the SLICC/ACR DI
  • Stable pharmacological treatment
  • The ability to perform a maximal ergometercycle exercise test
  • Be able to read and understand Swedish

Exclusion criteria

  • Symptoms or signs of cerebro-vascular disease, pulmonary embolus, pulmonary hypertension, pulmonary fibrosis, cardiovascular disease, angina pectoris, myocardial infarction, dyspnea at rest, uncontrolled blood pressure and uncontrolled diabetes within one year prior to study entry. Chronic kidney disease with
  • Patients who fulfil the absolute contraindications for maximal exercise testing according to American Heart Association
  • Patients who cannot perform a maximal ergometercycle exercise test due to the disease
  • Diseases or other conditions that strongly reduce the ability to exercise or that exercise is not recommended
  • Patients who perform regular aerobic fitness training and muscle strength exercise sessions at fixed times, >1 time/week
  • Pregnancy

Treatment and study plan

HIIT combined with resistance training

Behavioral

Patients with SLE will undergo supervised HIIT on an ergometercycle, 4 x 4 minutes interval, (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week.

Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week.

Primary outcomes

  1. Aerobic capacity

    Time frame: Baseline, months 3 and 6

    Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test

  2. Physical capacity

    Time frame: Baseline, months 3 and 6

    Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test

Secondary outcomes

  1. Muscle function upper extremity

    Time frame: Baseline, months 3 and 6

    How many shoulder flexions (0-90 degrees), in a given pace, with a 3 kg (men) or 2 kg (women) dumbbell in the hand is possible to do

  2. Self-reported disease activity

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire Systemic Lupus Erythematosus Activity Questionnaire includes three parts. The part about disease symptoms goes from 0-47 points, the higher the points the more disease symptoms. Further there is a question about flares with four answer alternatives, from no flares to serious flares. There is also a numerical rating scale about disease activity on a scale from 0-10, the higher value the higher the disease activity

  3. Fatigue

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire Functional Assessment of Chronic Illness Therapy, FACIT-Fatigue goes from 0-52 points, the higher the value, the less the fatigue

  4. Anxiety and depressive symptoms

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire Hospital Anxiety and Depression scale goes from 0-21 points, the higher the value, the higher the anxiety and depressive symptoms. In the anxiety and depressive symptoms subscales the points goes from 0-6, the higher the value, the higher anxiety and depressive symptoms respectively

  5. Quality of life in SLE

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire Lupus Quality of life questionnaire goes from 0-100 points, the higher the value the better the quality of life

  6. Generic Quality of life

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire Short Form Health Survey (SF-36). Each subscale goes from 0-100 points, the higher the value, the higher the quality of life.

  7. Quality of life and health status

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D). The index scores goes from -0,594 till 1,000, the higher the value, the higher the quality of life

  8. Disease activity

    Time frame: Baseline, months 3 and 6

    SLE Disease Activity Index 2000 (SLEDAI-2K) assessed by a physician, goes from 0-105 points, the higher the value, the higher the disease activity

  9. Inflammatory markers

    Time frame: Baseline, months 3 and 6

    Blood samples are collected before and after maximal ergometercycle exercise test

  10. Health status

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D)-5L Visual analogue scale, 0-100 mm, the higher the value, the better the health

  11. Blood pressure

    Time frame: Baseline, month 3 and 6

    Resting diastolic and systolic blood pressure

Other outcomes

  1. Organ damage

    Time frame: Baseline and 6 months

    Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index). Organ damage last 6 months, assessed by a physician. The points goes from 0-47, the higher the value, the more organ damage

  2. Demographical, clinical and lifestyle behaviour data including age, gender, ethnic origin, and smoking status as well as other for the project important information about the disease such as autoantibody profiles and pharmacological treatment

    Time frame: Baseline. For some variables, such as medical treatment, also months 3 and 6

    A questionnaire developed specific for this project and data from patients medical files

  3. Physical activity

    Time frame: Baseline, months 3 and 6

    The patient-reported questionnaire International Physical Activity Questionnaire addresses the number of days and time spent on physical activity in moderate intensity, vigorous intensity and walking of at least 10-min duration the last 7 days, and also includes time spent sitting on weekdays the last 7 days. The sum score is expressed in physical activity Metabolic Equivalent of Task-minutes per day or week

  4. Activity-minutes and sitting behaviour

    Time frame: Baseline, months 3 and 6

    The patient-reported questions about Activity-minutes and sitting behaviour according to the Swedish National Board of Health and Welfare. For the two questions about physical training and exercise with 5 respective 6 answer alternatives, the higher the value, the more time spending training and exercising. The question about sitting have 7 answer alternatives, the higher the value, the less time spent sitting

  5. Weight

    Time frame: Baseline, months 3 and 6

    Weight in kilograms

  6. Height

    Time frame: Baseline

    Height in meters

  7. Body Mass Index (BMI)

    Time frame: Baseline, months 3 and 6

    Weight in kilograms divided by the height in metres squared

  8. Muscle function lower extremity

    Time frame: Baseline, months 3 and 6

    How many times is it possible to raise from a chair during 30 seconds; the "30 seconds Chair stand test"

Study contacts

Contact information is provided by the study sponsor or research team.

Carina M Boström, Dr

CONTACT

[email protected]

046 0722006321

Ioannis Parodis, Dr

CONTACT

[email protected]

046 0722321322

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • County Council of Norrbotten, Sweden
  • Karolinska University Hospital
  • Region Örebro County
  • Swedish Rheumatism Association

Registry information

Official study title

Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus

Acronym: SLE-HIIT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
Dec 12, 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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