Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Despite recent, revolutionary improvements in pharmacologic management, rheumatoid arthritis (RA) remains associated with increased rates of cardiovascular disease and mortality. RA cardiovascular risk results from a combination of traditional risk factors and RA-related systemic inflammation. Consequently, to improve overall RA cardiovascular risk, efforts should target both traditional risk factors and inflammation. One hypothetical means of improving overall RA cardiovascular risk is through weight loss and physical activity. Together, weight loss and physical activity can improve traditional cardiometabolic health through fat mass loss and skeletal muscle quality and functional gains. Additionally, disease-related cardiovascular risk will improve as both fat mass loss and exercise reduce systemic inflammation.

This study will explore whether a supervised intervention with weight loss and exercise training improves objective assessments of RA cardiovascular risk, disease activity and results in patients reporting overall improved health.  Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence. The study proposes comparing two options to improve cardiovascular risk in RA: 1) diet and exercise counseling and 2) supervised weight loss and exercise training. This work will help provide information for future studies to improve cardiovascular health in RA.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:             60 Years to 80 Years   (Adult, Older Adult)

Sexes Eligible for Study:           All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

  • Body mass index (BMI) 30-40 kg/m2.
  • Must own a smart phone.
  • 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
  • No new medications within the last three months and stable doses for ≥ 1 month.

 

Exclusion Criteria:

  • Current use of biologic agents other than those targeting tumor necrosis factor alpha.
  • Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
  • Participating in regular exercise (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
  • Diagnosis of coronary artery disease
  • Diagnosis of type 2 diabetes mellitus.
  • Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease.
  • Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection.
  • Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.

Study Design:

Allocation:       Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Study Location(s):

Duke University, Durham, North Carolina, United States, 27708

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04356183?term=NCT04356183&draw=2&rank=1

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