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

Arthritis, Rheumatoid Clinical Trial

Official title:

Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00855322
• Other study ID #: RAEx-0809
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 2, 2009
• Last updated: March 2, 2009
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2009
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Gym exercise group intervention
Gym based circuit class
• Hydrotherapy group exercise intervention
Hydrotherapy group exercise class
• Control group
No intervention

Locations

Country	Name	City	State
Ireland	Our Lady's Hospice	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stanford Health Assessment Questionnaire		Baseline, 8 weeks and 24 weeks	No
Secondary	50 foot Walk Test		Baseline, 8 weeks and 24 weeks	No