Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial

Abstract

Background Obesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program. Methods 88 participants with painful knee OA and body mass index (BMI) > 27 kg/m2 will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20–30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50–75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures. Discussion This trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity. Trial registration NIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).

Effectiveness of Different Telerehabilitation Strategies on Pain and Physical Function in Patients With Knee Osteoarthritis: Systematic Review and Meta-Analysis

“…Meanwhile, telerehabilitation strategies, including educational lectures, medical suggestions, and psychotherapy were effective for the reduction of pain [ 23 ]. Furthermore, Bennell et al [ 49 ] suggested that telehealth-delivered exercise and diet programs improved pain in people with knee OA and overweight or obesity, which indicated that diet also plays an important role in alleviating pain in patients with knee OA. These telerehabilitation programs could combine various interventions to ease pain.…”

Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial

“…This was a two-group, superiority, parallel-design randomised controlled trial (RCT) prospectively registered (Clinicaltrials.gov NCT04733053), protocol published,20 approved by the University of Melbourne Human Research Ethics Committee (HREC 1955042). The only change to trial methods was allowing participants to self-report follow-up body weight over the telephone using their own scales if they were unable to attend follow-up.…”

“…Participant satisfaction with their intervention was assessed using a seven-point global rating scale (‘extremely dissatisfied’ to ‘extremely satisfied’, ‘moderately’ or ‘extremely’ satisfied, categorised as ‘satisfied’). Other process measures collected and a nested qualitative study of participants and physiotherapists20 will be reported separately.…”