Resistance Exercise in Rheumatic Disease

Rheumatoid Arthritis Clinical Trial

Official title:

Resistance Exercise in Rheumatic Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01599260
• Other study ID #: NA_00069415
• Status: Terminated
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Collagen Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis
• Systemic Vasculitis
• Vasculitis

Intervention

Other:
• Resistance Exercise
Two 30-minute individually supervised exercise sessions per week for 16-weeks

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Campus	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with rheumatoid arthritis flares during the study	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.	up to 16 weeks
Primary	Number of participants with reported physical injuries during the study	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.	up to 16 weeks
Secondary	Change in Body composition after 16 weeks of resistance exercise	To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).	16 weeks
Secondary	Change in Strength after 16 weeks of resistance exercise	We will test if strength increases before and after the exercise intervention	16 weeks
Secondary	Change in Functional status after 16 weeks of resistance exercise	We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks	16 weeks
Secondary	Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.	16 weeks
Secondary	Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.	16 weeks
Secondary	Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise	Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their ESR	16 weeks