Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

Phase 2

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: Gym exercise group intervention; Other: Hydrotherapy group exercise intervention; Other: Control group

• Registration Number: NCT00855322
• Lead Sponsor: University College Dublin

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 Timeline

• Study Start: 2008-01
• Status Verified: 2009-02
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Last Update Submitted: 2009-03-02
• Study First Posted: 2009-03-04
• Last Update Posted: 2009-03-04
• Primary Completion: 2009-07
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gym exercise group intervention	Gym group exercise intervention
2	Hydrotherapy group exercise intervention	Hydrotherapy group exercise intervention
3	Control group	Control group

Primary Outcome Measures

Name	Time	Method
Stanford Health Assessment Questionnaire	Baseline, 8 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
50 foot Walk Test	Baseline, 8 weeks and 24 weeks

Trial Locations

Locations (1)

Our Lady's Hospice; 🇮🇪 Dublin, Ireland