ClinicalTrials.gg
TerminatedNCT01599260Updated Apr 9, 2019

Resistance Exercise in Rheumatic Disease

An interventional study of Resistance Exercise in Rheumatoid Arthritis and Systemic Vasculitis, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-09.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding ended.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
45 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Systemic Vasculitis
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's enrollment of 15 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non-English speaking
  • Pregnancy
  • Absolute cardiac or pulmonary to exercise
  • pacemaker
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • OtherResistance Exercise

    Two 30-minute individually supervised exercise sessions per week for 16-weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 16 weeks

  2. 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.

    Time frame: up to 16 weeks

Secondary outcomes

  1. 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).

    Time frame: 16 weeks

  2. Change in Strength after 16 weeks of resistance exercise

    We will test if strength increases before and after the exercise intervention

    Time frame: 16 weeks

  3. 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

    Time frame: 16 weeks

  4. 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.

    Time frame: 16 weeks

  5. 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.

    Time frame: 16 weeks

  6. 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

    Time frame: 16 weeks

07

Study locations

1 site
  • Johns Hopkins Bayview Medical Campus
    Baltimore, Maryland 21224, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2012 to primary completion in Dec 2018, 79 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2012
First posted
May 15, 2012
StartActual
May 2012
Primary completionActual
Dec 2018
CompletionActual
Dec 2018
Last update
Apr 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01599260
Responsible party
Sponsor
First posted
May 15, 2012
Start date
May 2012
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Apr 9, 2019

Study contacts

Rebecca L Manno, M.D.
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion