Resistance Exercise in Rheumatic Disease
Verified December 2015 by Johns Hopkins University
Information provided by (Responsible Party):
Rebecca L Manno, Johns Hopkins University
First received: May 7, 2012
Last updated: December 22, 2015
Last verified: December 2015
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.
Other: Resistance Exercise
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Resistance Exercise in Rheumatic Disease
Primary Outcome Measures:
- 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. We will track any major (and minor) injuries which are attributed to the exercise progrm.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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
|Ages Eligible for Study:
||45 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, ANCA-associated vasculitis, or giant cell arteritis)
- Non-English speaking
- Absolute cardiac or pulmonary contraindication to exercise
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: NCT01599260
|Johns Hopkins Bayview Medical Campus
|Baltimore, Maryland, United States, 21224 |
|Contact: Rebecca Manno, MD 410-550-0722 |
Johns Hopkins University
||Rebecca L Manno, Assistant Professor of Medicine, Johns Hopkins University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 7, 2012
||December 22, 2015
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2016
Connective Tissue Diseases
Immune System Diseases