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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Trine Seneca, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01553305
First received: March 4, 2012
Last updated: May 29, 2012
Last verified: May 2012
History of Changes

March 4, 2012
May 29, 2012
January 2012
June 2012   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01553305 on ClinicalTrials.gov Archive Site
Change in cardiovascular fitness [ Time Frame: Cardiovascular fitness is measured at baseline and follow-up. The outcome is change in cardiovascular fitness in 12 weeks from baseline to follow-up. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Arthritis, Rheumatoid
  • 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.
  • Other: Exercise programme
    Supervised exercise programme
  • Experimental: Supervised exercise programme
    Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.
    Interventions:
    • Other: Supervised high-intensity exercise programme
    • Other: Exercise programme
  • No Intervention: Unsupervised exercise programme
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
46
August 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01553305
AarhusUH-TS, AarhusUH-TS
No
Trine Seneca, Aarhus University Hospital
Aarhus University Hospital
Not Provided
Principal Investigator: Trine Seneca Aarhus University Hospital, Department of Physiotherapy
Aarhus University Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP