RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06841562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Johanna Johnson, MS

CONTACT

19196606766

johanna.johnson@duke.edu

Brian J Andonian, MD, MHSc

CONTACT

19196606743

brian.andonian@duke.edu

Principal Investigator

Brian J Andonian, MD, MHSc

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Brian J Andonian, MD, MHSc, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

exercise training

Additional Relevant MeSH Terms

Rheumatoid Arthritis