Rheumatoid Arthritis
Conditions
Keywords
exercise training
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.
Interventions
BEHAVIORALTRAINERa intensive exercise training
Remotely-delivered exercise training intervention
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of exercise training intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of exercise training intervention | 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. |
| Safety of exercise training intervention | 12 weeks | Safety will be measured by adverse events and serious adverse events. |
Countries
United States
Contacts
CONTACTJohanna Johnson, MS
CONTACTBrian J Andonian, MD, MHSc
PRINCIPAL_INVESTIGATORBrian J Andonian, MD, MHSc
Duke University
Outcome results
None listed