High-intensity Interval Exercise in Rheumatoid Arthritis

Not Applicable

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: High intensity exercise

• Registration Number: NCT05768165
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Primary Completion: 2023-06-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	High intensity exercise	Cardiorespiratory and strength exercise training 2-3 sessions per week

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary function	0 -12 weeks	Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)

Secondary Outcome Measures

Name	Time	Method
Erythrocyte Sedimentation Rate (ESR)	0-12 months	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Vascular function	0-12 weeks	Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)
Level of disease activity	0-12 months	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Homeostatic model assessment of insulin resistance (HOMA IR)	0-12 weeks	Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR
Glycosylation level of hemoglobin (HbA1c)	0-12 weeks	Glycosylation level of hemoglobin (mmol/mol)
Level of blood lipids	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 )
C-Reactive Protein (CRP)	0-12 months	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Cytokine levels	0-12 weeks	Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)
Muscle function of lower extremities	0-12 weeks	The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)
Hand-grip force	0-12 weeks	Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)
Self-reported physical activity	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)
Objective assessment of physical activity	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.)
Pain intensity	0-12 months	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Waist circumference	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)
Global health	0-12 months	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Fatigue	0-12 months	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Sleep	0-12 months	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Attitude to exercise	0-12 months	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Body compositions	0-12 weeks	Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)
Activity limitations	0-12 months	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)

Trial Locations

Locations (2)

Sahlgrenska university hospital; 🇸🇪 Göteborg, Sweden

Uddevalla Hospital; 🇸🇪 Uddevalla, Sweden