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

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supervised high-intensity exercise programme
Exercise programme
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Rheumatoid focused on measuring exercise programme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital, Department of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supervised exercise programme

Unsupervised exercise programme

Arm Description

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

Outcomes

Primary Outcome Measures

Change in muscle strength (kg)

Secondary Outcome Measures

Change in cardiovascular fitness

Full Information

First Posted
March 4, 2012
Last Updated
July 3, 2013
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01553305
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
exercise programme

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise programme
Arm Type
Experimental
Arm Description
Six-weeks supervised high-intensity exercise programme with training sessions twice a week followed by 6-weeks unsupervised exercise programme.
Arm Title
Unsupervised exercise programme
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Supervised high-intensity exercise programme
Intervention Description
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
Intervention Name(s)
Exercise programme
Intervention Description
Supervised exercise programme
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Seneca
Organizational Affiliation
Aarhus University Hospital, Department of Physiotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Department of Physiotherapy
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26239594
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.
Results Reference
derived

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

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