Clinical trial NCT01553305: A Study of the Effect of Supervised Exercise Programme in Patients With Rheumatoid Arthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: exercise programme
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in muscle strength (kg)
timeFrame: 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:
measure: Change in cardiovascular fitness
timeFrame: Cardiovascular fitness is measured at baseline and follow-up. The outcome is change in cardiovascular fitness in 12 weeks from baseline to follow-up.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Physiotherapy
Study officials:
affiliation: Aarhus University Hospital, Department of Physiotherapy
name: Trine Seneca
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.