TRAINERa Exercise for Early Rheumatoid Arthritis

This study is testing a remotely-delivered exercise program called TRAINERa intensive exercise training for people with early Rheumatoid Arthritis (RA). RA is a long-term disease that causes joint pain, swelling, and stiffness. The main goal is to see if this exercise program is practical and if people can stick with it, specifically if more than 60% of participants follow the exercise plan during the last 6 weeks of the 12-week program. You might be able to join if you are 18 or older, have been diagnosed with RA for 6 months or less, and are not currently taking certain strong RA medications called biologic DMARDs. You can be on other common RA medications like hydroxychloroquine or methotrexate. The study is currently unclear about its recruitment status and plans to enroll 15 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 15 participants to assess the feasibility of the exercise program.
What's involved
The study involves a 12-week remotely-delivered exercise training intervention. The primary endpoint measures adherence to the exercise protocol over the final 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06841562

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Recruiting
NAAges 18+InterventionalTreatment
Duke University
~15 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:TRAINERa intensive exercise training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of exercise training intervention
Measured over The primary feasibility target is participant adherence to the intervention protocol exercise prescription averaged over the course of the final 6 weeks of the 12-week program > 60%.
Rheumatoid Arthritis
1 sites across 1 states
North Carolina1
  • Brian J Andonian, MD, MHSc · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and not currently taking biologic DMARD therapy. Participants may be on one or a combination of the following conventional synthetic DMARDs: hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, azathioprine
Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs
History of fulfilling 2010 ACR/EULAR Classification Criteria for RA
Active RA, not in clinical disease remission (Clinical Disease Activity Index for RA (CDAI) \> 2.8)
Stable doses (for ≥ 1 month) of all RA and cardiovascular risk-related medications (including statins, metformin, SGLT2 inhibitors, GLP1RA) except for glucocorticoids

Exclusion

Pregnant or intending to become pregnant during the intervention period
Current treatment with exogenous insulin
Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease
Current malignancy other than minimally invasive carcinomas routinely treated topically or with minor surgical treatment
Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension (see below), significant anemia, important electrolyte imbalance, and hyperthyroidism
Acute myocardial infarction (MI) within six months
Resting hypertension with systolic or diastolic blood pressures ≥180/110 mm Hg
Lack of internet access
Planned, intentional weight loss during study
  • Feasibility of exercise training interventionThe primary feasibility target is participant adherence to the intervention protocol exercise prescription averaged over the course of the final 6 weeks of the 12-week program > 60%.

    Feasibility will be measured as a dichotomous outcome through patient adherence, defined as meeting 100% of the prescribed exercise protocol, on average.