Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis
Recruiting · NCT06841562 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
TRAINERa intensive exercise training
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Duke University - Durham, North Carolina, United States