This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments gym exercise group intervention, hydrotherapy group exercise intervention, control group
Phase phase 2
Sponsor University College Dublin
Start date January 2008
End date July 2009
Trial size 51 participants
Trial identifier NCT00855322, RAEx-0809


The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Gym group exercise intervention
gym exercise group intervention Gym Group
Gym based circuit class
Hydrotherapy group exercise intervention
hydrotherapy group exercise intervention Aquatic Physiotherapy
Hydrotherapy group exercise class
(No Intervention)
Control group
control group Control Group
No intervention

Primary Outcomes

Stanford Health Assessment Questionnaire
time frame: Baseline, 8 weeks and 24 weeks

Secondary Outcomes

50 foot Walk Test
time frame: Baseline, 8 weeks and 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Principal investigator Oliver FitzGerald, MB, BcH, BAO
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by University College Dublin.