High-intensity Interval Exercise in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: High intensity exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention versus care as usual
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Cardiorespiratory and strength exercise training 2-3 sessions per week | Behavioral: High intensity exercise<br>* 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.<br>* Other names: Person- centeredness;|
| No Intervention: Care as usual<br>Care as usual and information of health enhancing physical activity according to general recommendations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary function | Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity) | 0 -12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |