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 Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Systemic Vasculitis
• Intervention / Treatment: Other: Resistance Exercise

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Strength after 16 weeks of resistance exercise	We will test if strength increases before and after the exercise intervention	16 weeks
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
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Rebecca L Manno, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases; Vasculitis; Systemic Vasculitis
• Other Study ID Numbers: NA_00069415