Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06841562

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Alyssa Sudnick, MS

CONTACT

[email protected]

19196606769

Brian J Andonian, MD, MHSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRAINERa intensive exercise training

Behavioral

Remotely-delivered exercise training intervention

Primary outcomes

  1. Feasibility of exercise training intervention

    Time frame: 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 outcomes

  1. Acceptability of exercise training intervention

    Time frame: 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.

  2. Safety of exercise training intervention

    Time frame: 12 weeks

    Safety will be measured by adverse events and serious adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian J Andonian, MD, MHSc

CONTACT

[email protected]

19196606743

Johanna Johnson, MS

CONTACT

[email protected]

19196606766

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: TRAINERa

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.