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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University College Dublin

March 2, 2009
March 4, 2009
March 4, 2009
January 2008
July 2009   (Final data collection date for primary outcome measure)
Stanford Health Assessment Questionnaire [ Time Frame: Baseline, 8 weeks and 24 weeks ]
Same as current
No Changes Posted
50 foot Walk Test [ Time Frame: Baseline, 8 weeks and 24 weeks ]
Same as current
Not Provided
Not Provided
 
Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Other: Gym exercise group intervention
    Gym based circuit class
    Other Name: Gym Group
  • Other: Hydrotherapy group exercise intervention
    Hydrotherapy group exercise class
    Other Name: Aquatic Physiotherapy
  • Other: Control group
    No intervention
  • Experimental: 1
    Gym group exercise intervention
    Intervention: Other: Gym exercise group intervention
  • Experimental: 2
    Hydrotherapy group exercise intervention
    Intervention: Other: Hydrotherapy group exercise intervention
  • No Intervention: 3
    Control group
    Intervention: Other: Control group
Reid A, Brady A, Blake C, Mongey AB, Veale DJ, FitzGerald O, Cusack T. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
51
Same as current
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
 
NCT00855322
RAEx-0809
No
Not Provided
Not Provided
Dr Tara Cusack, University College Dublin
University College Dublin
Not Provided
Principal Investigator: Oliver FitzGerald, MB, BcH, BAO University College Dublin
Study Director: Tara Cusack, PhD, MMedSc, University College Dublin
University College Dublin
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP