Efficacy of a Combined Exercise and Nutrition Intervention Study for Outpatients with Possible Sarcopenia in Community-based Primary Care Clinics (ENdSarC): Study Protocol for a Multicenter Single-blinded Randomized Controlled Trial

Background: Sarcopenia is a geriatric disease characterized by loss of muscle mass and strength. Although combined exercise and nutrition intervention are known to be effective for sarcopenia, clinical trials involving outpatients 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 Korean older adults with possible sarcopenia in community-based primary care.

Methods: This multicenter, randomized, controlled trial will include 94 community-dwelling older outpatients 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 outpatients 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 outpatients 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).