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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00327275
First received: May 16, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Strength Training and Remicade Study

Resource links provided by NLM:


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

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

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

ClinicalTrials.gov processed this record on April 22, 2014