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

This study has been completed.

First Received: May 16, 2006 No Changes Posted

Sponsors and Collaborators:	University of Arizona Centocor, Inc.
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00327275

Purpose

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.

Condition	Intervention
Rheumatoid Arthritis	Behavioral: strength training

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	The Strength Training and Remicade Study

Further study details as provided by University of Arizona:

Primary Outcome Measures:

Strength
Body Composition
Function
Pain

Secondary Outcome Measures:

Quality of Life
Disease Activity
Fatigue

Estimated Enrollment:	35
Study Start Date:	March 2004
Estimated Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327275

Locations

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721

Sponsors and Collaborators

University of Arizona

Centocor, Inc.

Investigators

Principal Investigator:

Hilary G Flint-Wagner, PhD, MPH

Idaho State University

More Information

No publications provided

Study ID Numbers:	080192
Study First Received:	May 16, 2006
Last Updated:	May 16, 2006
ClinicalTrials.gov Identifier:	NCT00327275 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Infliximab
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009