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Clinical Trials/NCT01553305
NCT01553305
Completed
Not Applicable

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.

Aarhus University Hospital1 site in 1 country52 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis, Rheumatoid
Sponsor
Aarhus University Hospital
Enrollment
52
Locations
1
Primary Endpoint
Change in muscle strength (kg)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Trine Seneca

Physiotherapist

Aarhus University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in muscle strength (kg)

Time Frame: 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 Outcomes

  • 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.)

Study Sites (1)

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