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

Duke University

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: TRAINERa intensive exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT06841562

PRO00117047

Details and patient eligibility

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

TRAINERa intensive exercise training

Experimental group

Description:

Participants with early and active rheumatoid arthritis (RA) will complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program.

Treatment:

Behavioral: TRAINERa intensive exercise training