Rheumatoid ArthritisNCT01599260
Resistance Exercise in Rheumatic Disease
A study testing Resistance Exercise in people with Rheumatoid Arthritis and Systemic Vasculitis, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Vasculitis
- What is being tested?
- Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Non-English speaking
- Pregnancy
- Absolute cardiac or pulmonary contraindication to exercise
- pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Campus
Baltimore, Maryland, 21224
About this study
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.
- Conditions
- Rheumatoid Arthritis, Systemic Vasculitis
- Being tested
- Resistance Exercise
- Medical subject headings
- Arthritis, Rheumatoid, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
Two 30-minute individually supervised exercise sessions per week for 16-weeks
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Experimental | Subjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week. Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 16 weeks
Secondary outcomes (6)
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).
Measured: 16 weeks
Change in Strength after 16 weeks of resistance exercise
We will test if strength increases before and after the exercise intervention
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca L Manno, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599260
- Sponsor's protocol ID
- NA_00069415
- Status last verified
- Apr 2019
- First submitted
- 7 May 2012
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Exercise in Rheumatic Disease
- ClinicalTrials.gov ID
- NCT01599260
- Acronym / sponsor ID
- NA_00069415
- Conditions
- Rheumatoid Arthritis, Systemic Vasculitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Experimental | Other: Resistance ExerciseSubjects will participate in a 16 week long resistance exercise program which will consist of 2 30-minute individually supervised sessions per week. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- Non-English speaking
- Pregnancy
- Absolute cardiac or pulmonary contraindication to exercise
- pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseTwo 30-minute individually supervised exercise sessions per week for 16-weeks | Other | Resistance Exercise |
Primary outcome
Number of participants with rheumatoid arthritis flares during the study
Time frame: up to 16 weeks
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
Time frame: up to 16 weeks
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.
6 secondary outcomes
Change in Body composition after 16 weeks of resistance exercise
Time frame: 16 weeks
Change in Strength after 16 weeks of resistance exercise
Time frame: 16 weeks
Change in Functional status after 16 weeks of resistance exercise
Time frame: 16 weeks
Change in inflammatory cytokine Interleukin-6 (IL6) after 16 weeks of resistance exercise
Time frame: 16 weeks
Change in inflammatory cytokine C-reactive protein (CRP) after 16 weeks of resistance exercise
Time frame: 16 weeks
Change in Erythrocyte Sedimentation Rate (ESR) after 16 weeks of resistance exercise
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Funding ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L Manno, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise in people with Rheumatoid Arthritis and Systemic Vasculitis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with rheumatoid arthritis flares during the study (time frame: up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.