A Study of the Effect of Supervised Exercise Programme in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of a supervised high-intensity exercise programme followed by an unsupervised exercise programme to an unsupervised exercise programme in patients with Rheumatoid Arthritis.

Detailed Description
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Patients with Rheumatoid Arthritis are in general less fit and more at risk of comorbidities such as cardiovascular events compared with healthy age-matched controls. Studies indicates that patients with Rheumatoid Arthritis have a lower level of physical activity than the general population and a low proportion of patients with Rheumatoid Arthritis exercises. Regular exercise with moderate to high intensity level of intensity has proven to be effective in reducing the cardiovascular risk by improving cardiovascular fitness and to increase muscle strength. Therefore, it is of interest to investigate if supervised exercise programme makes a difference making patients with Rheumatoid Arthritis participate in exercise.

Official Title
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The Effect of 6-weeks Supervised Exercise Programme Followed by 6-weeks Unsupervised Exercise Programme Versus 12 Weeks Unsupervised Exercise Programme in Patients With Rheumatoid Arthritis.

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Other: Supervised high-intensity exercise programme
* Other: Exercise programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with Rheumatoid Arthritis within the last three years at Aarhus University Hospital according to the 1987 revised ACR criteria or the 2009 ACR/EULAR criteria must be able to sit on an exercise bike must be able to participate in 6-weeks exercise programme with training sessions twice a week at Aarhus University Hospital must be able to speak and understand danish Exclusion Criteria: high disease activity assessed by DAS28-CRP Myocardial Infarction within the last six months Angina Pectoris treated with beta-blocker severe high blood pressure severe lung disease

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise programme<br>Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme. | Other: Supervised high-intensity exercise programme<br>* Six-weeks supervised high-intensity muscle strength training and physical fitness with training sessions twice a week followed by 6-weeks unsupervised high-intensity exercise programme.<br>Other: Exercise programme<br>* Supervised exercise programme<br>|
| No Intervention: Unsupervised exercise programme<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength (kg) |  | Muscle strength is measured at baseline and follow-up. The outcome is change in muscle strength in 12 weeks from baseline to follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular fitness |  | Cardiovascular fitness is measured at baseline and follow-up. The outcome is change in cardiovascular fitness in 12 weeks from baseline to follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise programme