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

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: Supervised high-intensity exercise programme; Other: Exercise programme

• Registration Number: NCT01553305
• Lead Sponsor: Aarhus University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-04
• Study First Submitted QC: 2012-03-10
• Study First Posted: 2012-03-14
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise programme	Exercise programme	Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.
Supervised exercise programme	Supervised high-intensity exercise programme	Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Physiotherapy; 🇩🇰 Aarhus, Denmark