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

NCT ID
NCT06841562
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Duke University
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study

Enrollment: 15 participants (Estimated).

What is being studied

  • Behavioral: TRAINERa intensive exercise training

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • North Carolina, United States: 1

Sample of listed locations

  • Duke University — Durham, North Carolina, 27710, United States — Recruiting

Study details

Start date
July 14, 2025
Primary completion date
March 31, 2027
Completion date
March 31, 2027
First posted
February 24, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06841562
Registry last updated
March 19, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06841562 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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