Recruiting

Aerobic & Resistance Training

Sponsor:

Duke University

Code:

NCT06841562

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRAINERa intensive exercise training

Study Details

Brief summary:

The primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study.

Conditions

Rheumatoid Arthritis

Study ID

NCT06841562

Start date

Jul 14, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TRAINERa intensive exercise training

Participants with early and active rheumatoid arthritis (RA) will complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program.

Interventions

TRAINERa intensive exercise training

Remotely-delivered exercise training intervention

Primary outcome measure

  • Feasibility of exercise training intervention [ Time Frame: 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%. ]

Central Contacts and Locations

Central contacts

Johanna Johnson, MS

19196606766johanna.johnson@duke.edu

Brian J Andonian, MD, MHSc

19196606743brian.andonian@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Alyssa Sudnick, MS

19196606769alyssa.sudnick@duke.edu

Principal Investigator:

Brian J Andonian, MD, MHSc

More Information

Sponsor

Duke University

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • exercise training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-19.