Rheumatoid Arthritis Clinical Trial
Official title:
The Strength Training and Remicade Study
Verified date | May 2006 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | Centocor, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Strength | |||
Primary | Body Composition | |||
Primary | Function | |||
Primary | Pain | |||
Secondary | Quality of Life | |||
Secondary | Disease Activity | |||
Secondary | Fatigue |
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