RECRUITINGINTERVENTIONAL
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
TRAINERa intensive exercise training
Remotely-delivered exercise training intervention
Locations (1)
Duke University
Durham, North Carolina, United States