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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University College Dublin.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University College Dublin
ClinicalTrials.gov Identifier:
NCT00855322
First received: March 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication

Resource links provided by NLM:


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
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
Other Name: Control Group

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University College Dublin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Tara Cusack, University College Dublin
ClinicalTrials.gov Identifier: NCT00855322     History of Changes
Other Study ID Numbers: RAEx-0809
Study First Received: March 2, 2009
Last Updated: March 2, 2009
Health Authority: Ireland: Medical Ethics Research Committee

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

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

ClinicalTrials.gov processed this record on October 19, 2014