Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University College Dublin
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Stanford Health Assessment Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Hydrotherapy group exercise intervention
Intervention: Hydrotherapy group exercise intervention (Other)
3
Control group
Intervention: Control group (Other)
1
Gym group exercise intervention
Intervention: Gym exercise group intervention (Other)
Outcomes
Primary Outcomes
Stanford Health Assessment Questionnaire
Time Frame: Baseline, 8 weeks and 24 weeks
Secondary Outcomes
- 50 foot Walk Test(Baseline, 8 weeks and 24 weeks)