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

NCT ID: NCT01553305

Last Updated: 2013-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-07-31

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised exercise programme

Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.

Group Type: EXPERIMENTAL

Supervised high-intensity exercise programme

Intervention Type: OTHER

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

Intervention Type: OTHER

Supervised exercise programme

Unsupervised exercise programme

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Exercise programme

Supervised exercise programme

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Trine Seneca

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trine Seneca

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Department of Physiotherapy

Locations

Aarhus University Hospital, Department of Physiotherapy

Aarhus, , Denmark

Countries

Denmark

References

Seneca T, Hauge EM, Maribo T. Comparable effect of partly supervised and self-administered exercise programme in early rheumatoid arthritis--a randomised, controlled trial. Dan Med J. 2015 Aug;62(8):A5127.

Reference Type: DERIVED

PMID: 26239594 (View on PubMed)

Other Identifiers

AarhusUH-TS

Identifier Type: -

Identifier Source: secondary_id

AarhusUH-TS

Identifier Type: -

Identifier Source: org_study_id