Back to resultsStudy Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Primary Purpose
Arthritis, Rheumatoid
Status
Unknown status
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
Gym exercise group intervention
Hydrotherapy group exercise intervention
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid, Exercise, Biological Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients with RA receiving anti-TNFalpha therapy medication for more than three months
- Consenting male and female patients aged 18 - 70 years
- Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
- ACR functional class I, II, III
Exclusion Criteria:
- Patients who have attended physiotherapy in the past three months
- Patients to whom exercise therapy or hydrotherapy are contraindicated
- Patients who have undergone joint surgery in the past six months
Sites / Locations
- Our Lady's Hospice
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
Gym group exercise intervention
Hydrotherapy group exercise intervention
Control group
Outcomes
Primary Outcome Measures
Stanford Health Assessment Questionnaire
Secondary Outcome Measures
50 foot Walk Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855322
Brief Title
Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Official Title
Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University College Dublin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication
Detailed Description
Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication.
It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Rheumatoid, Exercise, Biological Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Gym group exercise intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Hydrotherapy group exercise intervention
Arm Title
3
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Gym exercise group intervention
Other Intervention Name(s)
Gym Group
Intervention Description
Gym based circuit class
Intervention Type
Other
Intervention Name(s)
Hydrotherapy group exercise intervention
Other Intervention Name(s)
Aquatic Physiotherapy
Intervention Description
Hydrotherapy group exercise class
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Stanford Health Assessment Questionnaire
Time Frame
Baseline, 8 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
50 foot Walk Test
Time Frame
Baseline, 8 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with RA receiving anti-TNFalpha therapy medication for more than three months
Consenting male and female patients aged 18 - 70 years
Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
ACR functional class I, II, III
Exclusion Criteria:
Patients who have attended physiotherapy in the past three months
Patients to whom exercise therapy or hydrotherapy are contraindicated
Patients who have undergone joint surgery in the past six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver FitzGerald, MB, BcH, BAO
Organizational Affiliation
University College Dublin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tara Cusack, PhD, MMedSc,
Organizational Affiliation
University College Dublin
Official's Role
Study Director
Facility Information:
Facility Name
Our Lady's Hospice
City
Dublin
ZIP/Postal Code
6W
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21232112
Citation
Reid A, Brady A, Blake C, Mongey AB, Veale DJ, FitzGerald O, Cusack T. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFalpha therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.
Results Reference
derived
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Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
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