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

NCT06841562 | Recruiting DMC

• 1 other identifier: PRO00117047
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

exercise training

Outcome Measures

Primary Outcomes (1)

• Feasibility of exercise training intervention

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

  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%.

Secondary Outcomes (2)

• Acceptability of exercise training intervention

  12 weeks

• Safety of exercise training intervention

  12 weeks

Study Arms (1)

TRAINERa intensive exercise training

EXPERIMENTAL

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.

Behavioral: TRAINERa intensive exercise training

Interventions

TRAINERa intensive exercise training BEHAVIORAL

Remotely-delivered exercise training intervention

TRAINERa intensive exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (1)

• Andonian BJ, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Belski KB, Counts JD, King AP, Wallis JT, Bennett WC, Gillespie JC, Moertl KM, Richard D, Huebner JL, Connelly MA, Siegler IC, Kraus WE, Bales CW, Porter Starr KN, Huffman KM. Effect of Remotely Supervised Weight Loss and Exercise Training Versus Lifestyle Counseling on Cardiovascular Risk and Clinical Outcomes in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial. ACR Open Rheumatol. 2024 Mar;6(3):124-136. doi: 10.1002/acr2.11639. Epub 2023 Dec 21.

  PMID: 38126260 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brian J Andonian, MD, MHSc

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Johnson, MS

CONTACT

19196606766; johanna.johnson@duke.edu

Brian J Andonian, MD, MHSc

CONTACT

19196606743; brian.andonian@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All scientific data from this project will be made available by the end of the award period or time of associated publication, whichever comes first.

Locations

US (1)