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The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis

NCT ID: NCT00327275

Last Updated: 2006-05-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-01-31

Brief Summary

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To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life.

We hypothesized that improvements would be seen in all of the above outcomes.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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strength training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females with RA
* Over 18 years of age
* ACR Functional Class I and II
* Taking Remicade \>4 months

Exclusion Criteria

* Presence of comorbid conditions contraindicated to exercise, including, but not limited to:

1. heart disease
2. severe osteoporosis: (if \>50 years): T score \< -3.0 for hip or spine excluded; T score \<-2.5 for hip or spine w/o current treatment)
3. (all potential subjects) previous non-traumatic fractures
4. uncontrolled BP
* BMI \>40
* Regular use of assistive walking device which would interfere with ability to lift weights
* Currently or within the last 3 months participating in aerobic exercise \> 150 minutes a week
* Currently or within the last 3 months participating in any regular strength training activities
* Presence of neurological impairment that directly limits ability to perform exercise
* Participation in concurrent exercise study
* Any reason for which the investigator deems it would not be in the patient's best interest to continue in the study
* Plans to move away from site within next 1 year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Principal Investigators

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Hilary G Flint-Wagner, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Idaho State University

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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080192

Identifier Type: -

Identifier Source: org_study_id