NCT05768165
Active, Not Recruiting
N/A
Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
Vastra Gotaland Region2 sites in 1 country87 target enrollmentAugust 16, 2021
ConditionsRheumatoid Arthritis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- Cardiopulmonary function
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Cardiopulmonary function
Time Frame: 0 -12 weeks
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)
Secondary Outcomes
- Vascular function(0-12 weeks)
- Level of disease activity(0-12 months)
- Homeostatic model assessment of insulin resistance (HOMA IR)(0-12 weeks)
- Glycosylation level of hemoglobin (HbA1c)(0-12 weeks)
- Level of blood lipids(0-12 weeks)
- Erythrocyte Sedimentation Rate (ESR)(0-12 months)
- C-Reactive Protein (CRP)(0-12 months)
- Cytokine levels(0-12 weeks)
- Muscle function of lower extremities(0-12 weeks)
- Hand-grip force(0-12 weeks)
- Self-reported physical activity(0-12 months)
- Objective assessment of physical activity(0-12 months)
- Pain intensity(0-12 months)
- Waist circumference(0-12 weeks)
- Global health(0-12 months)
- Fatigue(0-12 months)
- Sleep(0-12 months)
- Attitude to exercise(0-12 months)
- Body compositions(0-12 weeks)
- Activity limitations(0-12 months)
Study Sites (2)
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