Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia (MENTORS)

Effectiveness and Clinical Application of Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenic Older Adults With Metabolic Syndrome: Multicenter Randomized Controlled Trial

This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Combination product: Combined exercise and nutrition intervention; Other: Conventional medial care

Detailed Description

The definition of sarcopenia is age-related loss of skeletal muscle and physical functions. Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases. In particular, patients with metabolic syndrome showed a high prevalence of muscle loss and muscle weakness. It has been reported exercise in sarcopenia patients not only improved insulin sensitivity and physical performance but also helped the treatment of the diseases. Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. However, there is still not established standard protocol for the combined exercise-nutrition intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients older than 65 years and under 90 years
• patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
• patients who had metabolic syndrome

Exclusion Criteria:

• patients with less than estimated glomerular filtration rate (eGFR) 30
• patients with musculoskeletal or chronic lung disease incapable of exercise
• patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise
• patients less than 5 years after treatment of malignant tumor
• patients with liver cirrhosis, diabetes and other chronic disease
• patients who cannot perform combined exercise nutrition intervention for other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined exercise nutrition intervention group; Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period.	Combination product: Combined exercise and nutrition intervention; Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks). Exercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol. Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.
Active Comparator: Conventional medial care group; Conventional medical care service for 12weeks during intervention period.	Other: Conventional medial care; Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein-rich foods at their first visit. The control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-times chair stand test	Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance	Short Physical Performance Battery [range from 0 to 12 score]	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Gait speed test	measured by 6 meter gait speed	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Appendicular skeletal muscle mass	measured using Dual-energy X-ray absorptiometry (DEXA), Bioelectrical impedance analysis (BIA)	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Health Related Quality of Life	Evaluation of quality of life using EQ-5D [range from 5 to 25 score]. Higher value means worse quality of life	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Basic and instrumental activities of daily living	Evaluation of basic and instrumental activities of daily living using Korean Activity of Daily Living (K-ADL), Korean Instrumental Activity of Daily Living (K-IADL) [range from 0 to 33]. Low value means poor ability of activities.	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Sarcopenia screening questionnaire	Evaluation of quality of life using Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls (SARC-F) questionnair [range from 0 to 10].	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Nutritional Assessment	Evaluation of nutritional state using Mini-Nutritional Assessment (MNA) [range from 1 to 30 score], Korean Protein Assessment Tool (KPAT)	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Handgrip strength	Evaluation of hand grip strength using Hand-held dynamometer	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Cognitive assessment	Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) [range from 0 to 30 score]	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Psychiatric state	Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) [range from 0 to 30 score]	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Swallowing assessment	measured by Standardized Swallowing Assessment (SSA)	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Delirium assessment	Evaluation of delirium using Delirium Rating Scale (DRS) [range from 0 to 32 score]. Higher value means worse delrious status	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Physical acitivity assessment	measured by Korean Physical Activity Scale for the Elderly (K-PASE) [range from 0 to 1382.52 score]. Higher value means better physical status	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Empowerment assessment	measured by Korean version of Health Empowerment Scale (K-HES) [range from 8 to 40 score]. Higher value means better empowerment status	Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: National Evidence-Based Healthcare Collaborating Agency
• Investigators: Principal Investigator: Jae-Young Lim, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22.
• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
• Dent E, Morley JE, Cruz-Jentoft AJ, Arai H, Kritchevsky SB, Guralnik J, Bauer JM, Pahor M, Clark BC, Cesari M, Ruiz J, Sieber CC, Aubertin-Leheudre M, Waters DL, Visvanathan R, Landi F, Villareal DT, Fielding R, Won CW, Theou O, Martin FC, Dong B, Woo J, Flicker L, Ferrucci L, Merchant RA, Cao L, Cederholm T, Ribeiro SML, Rodriguez-Manas L, Anker SD, Lundy J, Gutierrez Robledo LM, Bautmans I, Aprahamian I, Schols JMGA, Izquierdo M, Vellas B. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018;22(10):1148-1161. doi: 10.1007/s12603-018-1139-9.
• Jang HC. How to Diagnose Sarcopenia in Korean Older Adults? Ann Geriatr Med Res. 2018 Jun;22(2):73-79. doi: 10.4235/agmr.2018.22.2.73. Epub 2018 Jun 30.
• Nipp RD, Fuchs G, El-Jawahri A, Mario J, Troschel FM, Greer JA, Gallagher ER, Jackson VA, Kambadakone A, Hong TS, Temel JS, Fintelmann FJ. Sarcopenia Is Associated with Quality of Life and Depression in Patients with Advanced Cancer. Oncologist. 2018 Jan;23(1):97-104. doi: 10.1634/theoncologist.2017-0255. Epub 2017 Sep 21.
• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
• Lee SY, Beom J, Choi JH, Jang HC, Kim E, Kim K, Kim M, Shim GY, Won CW, Lim JY. Effectiveness and clinical application of multidisciplinary combined exercise and nutrition intervention for sarcopenic older adults with metabolic syndrome: study protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Jul 14;13(7):e070252. doi: 10.1136/bmjopen-2022-070252.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): July 11, 2024
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Nutrition; Sarcopenia; Older adults; Standard intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sarcopenia; Motor Activity; Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: B-2010/645-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No