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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855322
Recruitment Status : Unknown
Verified February 2009 by University College Dublin.
Recruitment status was:  Active, not recruiting
First Posted : March 4, 2009
Last Update Posted : March 4, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Other: Gym exercise group intervention Other: Hydrotherapy group exercise intervention Other: Control group Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Study Start Date : January 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Gym group exercise intervention
Other: Gym exercise group intervention
Gym based circuit class
Other Name: Gym Group
Experimental: 2
Hydrotherapy group exercise intervention
Other: Hydrotherapy group exercise intervention
Hydrotherapy group exercise class
Other Name: Aquatic Physiotherapy
No Intervention: 3
Control group
Other: Control group
No intervention

Primary Outcome Measures :
  1. Stanford Health Assessment Questionnaire [ Time Frame: Baseline, 8 weeks and 24 weeks ]

Secondary Outcome Measures :
  1. 50 foot Walk Test [ Time Frame: Baseline, 8 weeks and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855322

Our Lady's Hospice
Dublin, Ireland, 6W
Sponsors and Collaborators
University College Dublin
Principal Investigator: Oliver FitzGerald, MB, BcH, BAO University College Dublin
Study Director: Tara Cusack, PhD, MMedSc, University College Dublin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Tara Cusack, University College Dublin Identifier: NCT00855322     History of Changes
Other Study ID Numbers: RAEx-0809
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: February 2009

Keywords provided by University College Dublin:
Arthritis, Rheumatoid
Biological Therapy

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases