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

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT06841562
• Lead Sponsor: Duke University

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.

Detailed Description

The primary aim of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise intervention program for patients with Rheumatoid Arthritis (RA) and to collect data to inform the design of a larger research study. This protocol will build upon a recent project, gathering additional data to support future grant applications. The findings will provide critical information for determining the design and appropriate sample size and ensuring sufficient statistical power for a larger study. Additionally, this pilot will evaluate the practicality of implementing a remotely supervised exercise training intervention in early and active RA patients, helping to establish its potential for broader clinical use.

Study Timeline

• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Study First Posted: 2025-02-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2026-04
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and prior to starting biologic disease modifying anti rheumatic drug (DMARD) therapy
• 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
• Modified contraindications to exercise testing: acute myocardial infarction (MI) within six months; resting hypertension with systolic or diastolic blood pressures >160/90 mm Hg
• Lack of internet access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of exercise training intervention	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%.	Feasibility will be measured as a dichotomous outcome through patient adherence, defined as meeting 100% of the prescribed exercise protocol, on average.

Secondary Outcome Measures

Name	Time	Method
Acceptability of exercise training intervention	12 weeks	Acceptability will be measured with dichotomous patient-reported responses to questions on willingness to recommend the current intervention to others with RA and willingness to participate in such a study again.
Safety of exercise training intervention	12 weeks	Safety will be measured by adverse events and serious adverse events.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States