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

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ClinicalTrials.gov Identifier: NCT00327275
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : May 18, 2006
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of Arizona

Brief Summary:

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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: strength training Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Strength Training and Remicade Study
Study Start Date : March 2004
Study Completion Date : January 2005

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Primary Outcome Measures :
  1. Strength
  2. Body Composition
  3. Function
  4. Pain

Secondary Outcome Measures :
  1. Quality of Life
  2. Disease Activity
  3. Fatigue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00327275     History of Changes
Other Study ID Numbers: 080192
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 18, 2006
Last Verified: May 2006

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases