Resistance Exercise in Rheumatic Disease
Primary Purpose
Rheumatoid Arthritis, Systemic Vasculitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
- Johns Hopkins Bayview Medical Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistance Exercise
Arm Description
Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
Change in Strength after 16 weeks of resistance exercise
We will test if strength increases before and after the exercise intervention
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
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01599260
Brief Title
Resistance Exercise in Rheumatic Disease
Official Title
Resistance Exercise in Rheumatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding ended.
Study Start Date
May 2012 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Systemic Vasculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance Exercise
Arm Type
Experimental
Arm Description
Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week.
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Description
Two 30-minute individually supervised exercise sessions per week for 16-weeks
Primary Outcome Measure Information:
Title
Number of participants with rheumatoid arthritis flares during the study
Description
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.
Time Frame
up to 16 weeks
Title
Number of participants with reported physical injuries during the study
Description
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.
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Change in Body composition after 16 weeks of resistance exercise
Description
To assess change in body composition associated with this resistance exercise protocol (after 16 weeks).
Time Frame
16 weeks
Title
Change in Strength after 16 weeks of resistance exercise
Description
We will test if strength increases before and after the exercise intervention
Time Frame
16 weeks
Title
Change in Functional status after 16 weeks of resistance exercise
Description
We will determine if functional status, as measured by the short physical performance battery, improves after 16 weeks
Time Frame
16 weeks
Title
Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise
Description
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.
Time Frame
16 weeks
Title
Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise
Description
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their inflammatory cytokine.
Time Frame
16 weeks
Title
Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise
Description
Participants will have blood drawn before and after 16 weeks of exercise to determine if changes have occurred in their ESR
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Manno, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
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Resistance Exercise in Rheumatic Disease
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