Clinical trial NCT01599260: Resistance Exercise in Rheumatic Disease
Official title: Resistance Exercise in Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Systemic Vasculitis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with rheumatoid arthritis flares during the study
timeFrame: up to 16 weeks
measure: Number of participants with reported physical injuries during the study
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Change in Body composition after 16 weeks of resistance exercise
timeFrame: 16 weeks
measure: Change in Strength after 16 weeks of resistance exercise
timeFrame: 16 weeks
measure: Change in Functional status after 16 weeks of resistance exercise
timeFrame: 16 weeks
measure: Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise
timeFrame: 16 weeks
measure: Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise
timeFrame: 16 weeks
measure: Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rebecca L Manno, M.D.
role: PRINCIPAL_INVESTIGATOR
References: