Remotely Supervised Weight Loss and Exercise Training to Improve Rheumatoid Arthritis Cardiovascular Risk: Rationale and Design of the Supervised Weight Loss Plus Exercise Training‐Rheumatoid Arthritis Trial

Abstract

Patients with rheumatoid arthritis (RA) remain at an increased risk for cardiovascular disease (CVD) and mortality. RA CVD results from a combination of traditional risk factors and RA‐related systemic inflammation. One hypothetical means of improving overall RA CVD risk is through reduction of excess body weight and increased physical activity. Together, weight loss and physical activity can improve traditional cardiometabolic health through fat mass loss, while also improving skeletal muscle health. Additionally, disease‐related CVD risk may improve as both fat mass loss and exercise reduce systemic inflammation. To explore this hypothesis, 26 older persons with RA and overweight/obesity will be randomized to 16 weeks of a usual care control arm or to a remotely Supervised Weight Loss Plus Exercise Training (SWET) program. A caloric restriction diet (targeting 7% weight loss) will occur via a dietitian‐led intervention, with weekly weigh‐ins and group support sessions. Exercise training will consist of both aerobic training (150 minutes/week moderate‐to‐vigorous exercise) and resistance training (twice weekly). The SWET remote program will be delivered via a combination of video conference, the study YouTube channel, and study mobile applications. The primary cardiometabolic outcome is the metabolic syndrome Z score, calculated from blood pressure, waist circumference, high‐density lipoprotein cholesterol, triglycerides, and glucose. RA‐specific CVD risk will be assessed with measures of systemic inflammation, disease activity, patient‐reported outcomes, and immune cell function. The SWET‐RA trial will be the first to assess whether a remotely supervised, combined lifestyle intervention improves cardiometabolic health in an at‐risk population of older individuals with RA and overweight/obesity.

Effect of Remotely Supervised Weight Loss and Exercise Training Versus Lifestyle Counseling on Cardiovascular Risk and Clinical Outcomes in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial

“…Trial design details, including eligibility, randomization, blinding, equipment, and remote interventions, were reported in the published protocol. 17 Participants were recruited from outpatient rheumatology clinics serving Duke Health in North Carolina. After screening for eligibility and informed consent, participants were examined by the study physician and assessed for readiness to complete cardiopulmonary exercise testing and the study exercise training intervention according to American College of Sports Medicine guidelines.…”

“…Details regarding each intervention component were described in detail in our previously published study rationale and design manuscript. 17 For the diet component, participants were supervised by a registered dietitian who provided an individualized hypocaloric diet prescription for a goal weight loss of 1 to 2 pounds per week, a loss of 7% body mass in total. Participants attended weekly live virtual group nutrition classes, completed weekly weigh‐ins (A&D Medical PLUSCONNECT wireless weight scale), and reported their weekly food intakes on the MyFitnessPal app, using their study‐provided tablet.…”

“…Considering standard of care to include referrals for nutrition and physical/occupational therapy, CHAT participants remotely completed two 60‐minute lifestyle counseling sessions followed by usual care. 17 For the first counseling session with a registered dietitian, participants received general dietary recommendations to improve overall health. 31 For the second counseling session with an exercise physiologist, participants received physical activity recommendations to improve overall health.…”

“…Based on data from non‐RA participants completing similar lifestyle interventions, sample sizes were calculated to detect a clinically significant difference in absolute MSSc change between the SWET and CHAT groups of 2.5 (SD = 2.1). 17 , 33 , 34 With 26 RA participants enrolled and randomized with an expected attrition rate of 20% to 25% during the intervention period, 10 participants per group provided 80% power at a one‐tailed α of 0.05 to detect a group difference of 2.5, in which each unit difference in MSSc corresponds to a hazard ratio for CVD of 1.49 (CI 1.37–1.62). 41 …”

“…As both overweight/obesity and physical inactivity significantly contribute to poor clinical outcomes in persons with RA, 17 , 18 , 19 lifestyle interventions, including weight loss and increased physical activity, have great potential for improving RA clinical care. 17 For example, intentional weight loss can improve RA disease activity and immune function, 20 , 21 , 22 whereas exercise training can also improve RA disease activity, as well as physical function, pain, sleep, fatigue, and overall health. 23 Indeed, the recent American College of Rheumatology (ACR) guidelines strongly recommend consistent engagement in exercise as part of an integrative approach to manage RA (24).…”