Resistance Exercise in Rheumatic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01599260
Recruitment Status : Recruiting
First Posted : May 15, 2012
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Systemic Vasculitis Other: Resistance Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistance Exercise in Rheumatic Disease
Actual Study Start Date : May 2012
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Safety [ Time Frame: 16 weeks ]
    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. We will track any major (and minor) injuries which are attributed to the exercise program.

Secondary Outcome Measures :
  1. Change in Body composition after 16 weeks of resistance exercise [ Time Frame: 16 weeks ]
    To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).

  2. Change in Strength after 16 weeks of resistance exercise [ Time Frame: 16 weeks ]
    We will test if strength increases before and after the exercise intervention

  3. Change in Functional status after 16 weeks of resistance exercise [ Time Frame: 16 weeks ]
    We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks

  4. Change in inflammatory cytokines (CRP, ESR, IL6) after 16 weeks of resistance exercise [ Time Frame: 16 weeks ]
    Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokines.

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01599260

Contact: Rebecca Manno, MD 410-550-0722
Contact: Marilyn C Towns, BSc 410-550-0579

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

Responsible Party: Johns Hopkins University Identifier: NCT01599260     History of Changes
Other Study ID Numbers: NA_00069415
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

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