Resistance Exercise in Rheumatic Disease

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis; Systemic Vasculitis

• Registration Number: NCT01599260
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, or giant cell arteritis)

Exclusion Criteria

• Non-English speaking
• Pregnancy
• Absolute cardiac or pulmonary contraindication to exercise
• pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with rheumatoid arthritis flares during the study	up to 16 weeks	Participants will be provided with questionnaires. They will be asked to report the number of arthritis flares since the last visit. Arthritis flares consist of pain and swelling of the joints. The total number of flares during the 16 week study will be reported.
Number of participants with reported physical injuries during the study	up to 16 weeks	Participants will be provided with questionnaires. They will be asked to report the number of injuries associated with the last visit (e.g. strains, sprains, and pulled muscles). The total number of injuries during the 16 week study will be reported.

Secondary Outcome Measures

Name	Time	Method
Change in Body composition after 16 weeks of resistance exercise	16 weeks	To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).
Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise	16 weeks	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their ESR
Change in Strength after 16 weeks of resistance exercise	16 weeks	We will test if strength increases before and after the exercise intervention
Change in Functional status after 16 weeks of resistance exercise	16 weeks	We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks
Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise	16 weeks	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.
Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise	16 weeks	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Campus; 🇺🇸 Baltimore, Maryland, United States