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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014