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

Sponsored by:	University College Dublin
Information provided by:	University College Dublin
ClinicalTrials.gov Identifier:	NCT00855322

Purpose

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

Condition	Intervention	Phase
Arthritis, Rheumatoid	Other: Gym exercise group intervention Other: Hydrotherapy group exercise intervention Other: Control group	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water Exercise and Physical Fitness Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by University College Dublin:

Primary Outcome Measures:

Stanford Health Assessment Questionnaire [ Time Frame: Baseline, 8 weeks and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

50 foot Walk Test [ Time Frame: Baseline, 8 weeks and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	51
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gym group exercise intervention	Other: Gym exercise group intervention Gym based circuit class
2: Experimental Hydrotherapy group exercise intervention	Other: Hydrotherapy group exercise intervention Hydrotherapy group exercise class
3: No Intervention Control group	Other: Control group No intervention

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855322

Locations

Ireland
Our Lady's Hospice
Dublin, Ireland, 6W

Sponsors and Collaborators

University College Dublin

Investigators

Principal Investigator:	Oliver FitzGerald, MB, BcH, BAO	University College Dublin
Study Director:	Tara Cusack, PhD, MMedSc,	University College Dublin

More Information

No publications provided

Responsible Party:	University College Dublin ( Dr Tara Cusack )
Study ID Numbers:	RAEx-0809
Study First Received:	March 2, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00855322 History of Changes
Health Authority:	Ireland: Medical Ethics Research Committee

Keywords provided by University College Dublin:

Arthritis, Rheumatoid
Exercise
Biological Therapy

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009