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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and prior to starting biologic disease modifying anti rheumatic drug (DMARD) therapy.
  • - 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.
  • - Modified contraindications to exercise testing: acute myocardial infarction (MI) within six months; resting hypertension with systolic or diastolic blood pressures >160/90 mm Hg.
- Lack of internet access

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06841562
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brian J Andonian, MD, MHSc
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Behavioral: - TRAINERa intensive exercise training

Remotely-delivered exercise training intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina, 27710

Site Contact

Johanna Johnson, MS

[email protected]

919-660-6766