Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
1 other identifier
interventional
51
1 country
1
Brief Summary
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 4, 2009
February 1, 2009
1.5 years
March 2, 2009
March 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stanford Health Assessment Questionnaire
Baseline, 8 weeks and 24 weeks
Secondary Outcomes (1)
50 foot Walk Test
Baseline, 8 weeks and 24 weeks
Study Arms (3)
1
EXPERIMENTALGym group exercise intervention
2
EXPERIMENTALHydrotherapy group exercise intervention
3
NO INTERVENTIONControl group
Interventions
Hydrotherapy group exercise class
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Our Lady's Hospice
Dublin, Dublin, 6W, Ireland
Related Publications (1)
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.
PMID: 21232112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver FitzGerald, MB, BcH, BAO
University College Dublin
- STUDY DIRECTOR
Tara Cusack, PhD, MMedSc,
University College Dublin
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 4, 2009
Study Start
January 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 4, 2009
Record last verified: 2009-02