The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis
The Strength Training and Remicade Study
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Mar 2004
Shorter than P25 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedMay 18, 2006
May 1, 2006
May 16, 2006
May 16, 2006
Conditions
Outcome Measures
Primary Outcomes (4)
Strength
Body Composition
Function
Pain
Secondary Outcomes (3)
Quality of Life
Disease Activity
Fatigue
Interventions
Eligibility Criteria
You may qualify if:
- Males and females with RA
- Over 18 years of age
- ACR Functional Class I and II
- Taking Remicade \>4 months
You may not qualify if:
- Presence of comorbid conditions contraindicated to exercise, including, but not limited to:
- heart disease
- 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)
- (all potential subjects) previous non-traumatic fractures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Centocor, Inc.collaborator
Study Sites (1)
University of Arizona
Tucson, Arizona, 85721, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilary G Flint-Wagner, PhD, MPH
Idaho State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
March 1, 2004
Study Completion
January 1, 2005
Last Updated
May 18, 2006
Record last verified: 2006-05