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Search / Trial NCT06841562

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

Launched by DUKE UNIVERSITY · Feb 19, 2025

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Exercise Training

ClinConnect Summary

This clinical trial is studying a new exercise program designed for people with Rheumatoid Arthritis (RA). The goal is to see if a combination of aerobic (like walking or cycling) and resistance (like lifting weights) exercises delivered online can help patients with RA. This study will help researchers gather important information to plan for a larger study in the future.

To join the trial, participants need to be adults aged 65 to 74 who have been diagnosed with early RA for six months or less and have not yet started certain types of medication for it. They should have active symptoms of RA and be on stable doses of their current medications. Unfortunately, those who are pregnant, have certain other medical conditions, or lack internet access will not be eligible. If you join, you can expect to participate in an exercise program that you can do from home, with guidance provided remotely. This is an exciting opportunity to help improve our understanding of how exercise can benefit people with RA!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and prior to starting 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 \>160/90 mm Hg
  • Lack of internet access
  • Planned, intentional weight loss during study

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Brian J Andonian, MD, MHSc

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported