Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Göteborg University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Cardiorespiratory and strength exercise training 2-3 sessions per week |
|
| Care as usual | No Intervention | Care as usual and information of health enhancing physical activity according to general recommendations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiopulmonary function | Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity) | 0 -12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular function | Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function) | 0-12 weeks |
| Level of disease activity | Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Annelie Bilberg, PhD | Vastra Gotaland Region | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska university hospital | Gothenburg | 413 45 | Sweden | |||
| Uddevalla Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40968365 | Derived | Bilberg A, Bjersing J, Borjesson M, Sivertsson J, Mannerkorpi K. High-intensity exercise improves multidimensional fatigue and health-related quality of life in rheumatoid arthritis: a randomized controlled study. Arthritis Res Ther. 2025 Sep 18;27(1):176. doi: 10.1186/s13075-025-03643-3. | |
| 39179363 | Derived |
Not provided
Not provided
Individual participant data (IPD) that underlie results in a publication are available from the principal investigator (P.I.) on reasonable request. Access will be determined based on reasonable request and in accordance with the ethical approval
Not provided
The data will become available as following, starting 6 months after publication and end 5 years after publication.
The requests will be reviewed by the P.I. and the steering committee. Study plans on meta-analyses generating new knowledge on exercise in persons with rheumatic diseases will be approved.
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
Intervention versus care as usual
Not provided
Not provided
Single blinded
|
|
| 0-12 weeks |
| Level of disease activity | Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity) | 0-6 months |
| Level of disease activity | Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity) | 0-12 months |
| Homeostatic model assessment of insulin resistance (HOMA IR) | Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR | 0-12 weeks |
| Glycosylation level of hemoglobin (HbA1c) | Glycosylation level of hemoglobin (mmol/mol) | 0-12 weeks |
| Level of blood lipids | Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L ) | 0-12 weeks |
| Erythrocyte Sedimentation Rate (ESR) | Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation) | 0-12 weeks |
| Erythrocyte Sedimentation Rate (ESR) | Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation) | 0-6 months |
| Erythrocyte Sedimentation Rate (ESR) | Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation) | 0-12 months |
| C-Reactive Protein (CRP) | Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation) | 0-12 weeks |
| C-Reactive Protein (CRP) | Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation) | 0-6 months |
| C-Reactive Protein (CRP) | Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation) | 0-12 months |
| Cytokine levels | Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL) | 0-12 weeks |
| Muscle function of lower extremities | The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities) | 0-12 weeks |
| Hand-grip force | Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength) | 0-12 weeks |
| Self-reported physical activity | 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) | 0-12 weeks |
| Self-reported physical activity | 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) | 0-6 months |
| Self-reported physical activity | 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) | 0-12 months |
| Objective assessment of physical activity | 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.) | 0-12 weeks |
| Objective assessment of physical activity | 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.) | 0-6 months |
| Objective assessment of physical activity | 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.) | 0-12 months |
| Pain intensity | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain) | 0-12 weeks |
| Pain intensity | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain) | 0-6 months |
| Pain intensity | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain) | 0-12 months |
| Global health | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health) | 0-12 weeks |
| Global health | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health) | 0-6 months |
| Global health | Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health) | 0-12 months |
| Fatigue | The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue | 0-12 weeks |
| Fatigue | The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue | 0-6 months |
| Fatigue | The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue | 0-12 months |
| Sleep | Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality). | 0-12 weeks |
| Sleep | Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality). | 0-6 months |
| Sleep | Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality). | 0-12 months |
| Activity limitations | Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations) | 0-12 weeks |
| Activity limitations | Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations) | 0-6 months |
| Activity limitations | Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations) | 0-12 months |
| Attitude to exercise | Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs. | 0-12 weeks |
| Attitude to exercise | Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs. | 0-6 moths |
| Attitude to exercise | Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs. | 0-12 months |
| Body compositions | Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight) | 0-12 weeks |
| Waist circumference | 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) | 0-12 weeks |
| Uddevalla |
| Sweden |
| Bilberg A, Mannerkorpi K, Borjesson M, Svedlund S, Sivertsson J, Klingberg E, Bjersing J. High-intensity interval training improves cardiovascular and physical health in patients with rheumatoid arthritis: a multicentre randomised controlled trial. Br J Sports Med. 2024 Dec 2;58(23):1409-1418. doi: 10.1136/bjsports-2024-108369. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |