A Study of the Effect of Supervised Exercise Programme in Patients With Rheumatoid Arthritis
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.
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 4, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 4, 2013
July 1, 2013
1.5 years
March 4, 2012
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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 Arms (2)
Supervised exercise programme
EXPERIMENTALSix-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.
Unsupervised exercise programme
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital, Department of Physiotherapy
Aarhus, 8000, Denmark
Related Publications (1)
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.
PMID: 26239594DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trine Seneca
Aarhus University Hospital, Department of Physiotherapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
March 4, 2012
First Posted
March 14, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 4, 2013
Record last verified: 2013-07