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

NCT ID: NCT00855322

Last Updated: 2009-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Gym group exercise intervention

Group Type EXPERIMENTAL

Gym exercise group intervention

Intervention Type OTHER

Gym based circuit class

2

Hydrotherapy group exercise intervention

Group Type EXPERIMENTAL

Hydrotherapy group exercise intervention

Intervention Type OTHER

Hydrotherapy group exercise class

3

Control group

Group Type NO_INTERVENTION

Control group

Intervention Type OTHER

No intervention

Interventions

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Gym exercise group intervention

Gym based circuit class

Intervention Type OTHER

Hydrotherapy group exercise intervention

Hydrotherapy group exercise class

Intervention Type OTHER

Control group

No intervention

Intervention Type OTHER

Other Intervention Names

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Gym Group Aquatic Physiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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University College Dublin

Principal Investigators

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Oliver FitzGerald, MB, BcH, BAO

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Tara Cusack, PhD, MMedSc,

Role: STUDY_DIRECTOR

University College Dublin

Locations

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Our Lady's Hospice

Dublin, Dublin, Ireland

Site Status

Countries

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Ireland

References

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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-TNFalpha therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.

Reference Type DERIVED
PMID: 21232112 (View on PubMed)

Other Identifiers

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RAEx-0809

Identifier Type: -

Identifier Source: org_study_id

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