Efficacy of Combined Exercise and Nutrition Intervention Study for Possible Sarcopenia in Community-Based Primary Care Clinics (ENdSarC): study protocol for a multicenter single-blinded randomized controlled trial

Abstract

Background Sarcopenia is a geriatric disease characterized by loss of muscle mass and strength. Although combined exercise and nutrition intervention is known to be effective for sarcopenia, clinical trials involving patients with sarcopenia in primary care are scarce. We describe a protocol for a trial to examine the effects of a 12-week combined exercise and nutrition intervention in older Korean adults with possible sarcopenia in community-based primary care. Methods This multicenter, randomized, controlled trial will include 94 community-dwelling older participants aged 65–85 years with possible sarcopenia (47 participants in the intervention and control groups each). Resistance exercises, which incorporate concentric and eccentric exercises, will consist of an introductory phase (3 weeks: twice-weekly supervised exercise sessions and once-weekly home exercises; contraction exercises), an expanded phase (3 weeks: twice-weekly supervised exercise sessions and once-weekly home exercises; eccentric exercises), and a maintenance phase (6 weeks: once-weekly supervised exercise sessions and twice-weekly home exercises; power/eccentric exercises). Nutritional supplementation will be provided according to the nutritional status of the participants using a Mini-Nutritional Assessment. Participants will be assessed at baseline, 12 and 24 weeks, and the primary outcome will be the 5-times chair stand test results. Discussion To the best of our knowledge, this will be the first clinical trial to evaluate the efficacy of a combined exercise and nutritional supplementation intervention in older patients with possible sarcopenia in community-based primary care clinics. These findings will provide new insights to clinicians regarding the long-term usability for doctors and patients with possible sarcopenia in community-based primary care. Trial registration: This trial was prospectively registered at ClinicalTrials.gov on September 16, 2023 (registration number: NCT06049914).