Resistance Exercise in Rheumatic Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Rebecca L Manno, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01599260
First received: May 7, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Systemic Vasculitis
Other: Resistance Exercise

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resistance Exercise in Rheumatic Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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.


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: 10
Study Start Date: May 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Contact: Rebecca Manno, MD 410-550-0722 rmanno3@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Campus Recruiting
Baltimore, Maryland, United States, 21224
Contact: Rebecca Manno, MD    410-550-0722      
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Rebecca L Manno, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01599260     History of Changes
Other Study ID Numbers: NA_00069415
Study First Received: May 7, 2012
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vasculitis
Systemic Vasculitis
Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014