RightFit
RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether people with early rheumatoid arthritis (RA) can take part in an intensive exercise program delivered remotely. RA causes joint swelling and pain. The program combines aerobic exercise, which raises your heart rate, with strength training and will help researchers plan a larger study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Diagnosed with RA within the past 6 months.
  • Not taking biologic RA drugs, a type of medicine that targets the immune system. Certain other RA drugs are allowed.
  • Have a positive blood test for rheumatoid factor or anti-CCP antibodies, or X-rays showing bone damage typical of RA.
  • Have met the 2010 ACR/EULAR medical standards for diagnosing RA.
  • Have active RA, with a disease activity score above 2.8.
  • Have had no dose changes for at least 1 month in RA medicines and medicines for heart-related risks. Steroid medicines are an exception.

Who can't join

  • Pregnant or planning to become pregnant during the exercise program.
  • Currently taking insulin.
  • Have certain other joint, muscle, bone, or body chemistry disorders listed by the study, such as a joint infection, Paget’s disease, or Wilson’s disease.
  • Have cancer now, except for certain small, minimally invasive cancers treated with skin medicines or minor surgery.
  • Have a condition that could make exercise testing unsafe or difficult. These include certain heart or blood vessel problems, blood clots, recent stroke, physical disabilities, trouble cooperating, or untreated medical problems.
  • Had a heart attack within 6 months, or have resting blood pressure with a top number of 180 or higher or a bottom number of 110 or higher.
  • Do not have internet access.
  • Plan to lose weight on purpose during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NC