Resistance Exercise in Rheumatic Disease
People with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. The medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. The investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. This will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. The investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Resistance Exercise in Rheumatic Disease|
- Safety [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]To ensure safety and tolerance of a resistance exercise protocol for patients with systemic vasculitis or rheumatoid arthritis. We will measure disease activity before and after each exercise session to determine if there is an association with the exercise program.
- Change in Body composition after 16 weeks of resistance exercise [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).
- Change in Strength after 16 weeks of resistance exercise [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]We will test if strength increases before and after the exercise intervention
- Change in Functional status after 16 weeks of resistance exercise [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks
- Change in inflammatory cytokines (CRP, ESR, IL6) after 16 weeks of resistance exercise [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokines.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: Resistance Exercise
Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week.
Other: Resistance Exercise
Two 30-minute individually supervised exercise sessions per week for 16-weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599260
|Contact: Rebecca Manno, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Campus||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Rebecca Manno, MD 410-550-0722|