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

Arthritis, Rheumatoid Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553305
• Other study ID #: AarhusUH-TS
• Secondary ID: AarhusUH-TS
• Status: Completed
• Phase: N/A
• First received: March 4, 2012
• Last updated: July 3, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Supervised high-intensity exercise programme
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.
• Exercise programme
Supervised exercise programme

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Physiotherapy	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes