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

March 2, 2009 updated by: University College Dublin

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 3
Control group
Other: Control group
No intervention
Experimental: 1
Gym group exercise intervention
Other: Gym exercise group intervention
Gym based circuit class
Other Names:
  • Gym Group
Experimental: 2
Hydrotherapy group exercise intervention
Other: Hydrotherapy group exercise intervention
Hydrotherapy group exercise class
Other Names:
  • Aquatic Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stanford Health Assessment Questionnaire
Time Frame: Baseline, 8 weeks and 24 weeks
Baseline, 8 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
50 foot Walk Test
Time Frame: Baseline, 8 weeks and 24 weeks
Baseline, 8 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAEx-0809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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