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

NCT ID: NCT06841562

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2026-09-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRAINERa intensive exercise training

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.

Group Type: EXPERIMENTAL

TRAINERa intensive exercise training

Intervention Type: BEHAVIORAL

Remotely-delivered exercise training intervention

Interventions

TRAINERa intensive exercise training

Remotely-delivered exercise training intervention

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian J Andonian, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johanna Johnson, MS

Role: CONTACT

johanna.johnson@duke.edu

19196606766

Brian J Andonian, MD, MHSc

Role: CONTACT

brian.andonian@duke.edu

19196606743

Facility Contacts

Alyssa Sudnick, MS

Role: primary

alyssa.sudnick@duke.edu

19196606769

References

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.

Reference Type: BACKGROUND

PMID: 38126260 (View on PubMed)

Other Identifiers

PRO00117047

Identifier Type: -

Identifier Source: org_study_id