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SarcopeniaMENTORSNCT04948736

Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia

A study testing Combined exercise and nutrition intervention and Conventional medial care in people with Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Sarcopenia
What is being tested?
Combined exercise and nutrition intervention and Conventional medial care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteSouth Korea
Study dates
8 Mar 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Sarcopenia
Being tested
Combined exercise and nutrition intervention, Conventional medial care
Keywords
Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention
Medical subject headings
Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined exercise and nutrition interventionCombination product

    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.

  • Conventional medial careOther

    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.

Study groups in NCT04948736
Study groupRoleWhat they receive
Combined exercise nutrition intervention groupExperimentalCustomized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period.
Receives: Combination Product: Combined exercise and nutrition intervention
Conventional medial care groupActive comparatorConventional medical care service for 12weeks during intervention period.
Receives: Other: Conventional medial care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

Secondary outcomes (14)
  1. Physical performance

    Short Physical Performance Battery [range from 0 to 12 score]

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  2. Gait speed test

    measured by 6 meter gait speed

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  3. Appendicular skeletal muscle mass

    measured using Dual-energy X-ray absorptiometry (DEXA), Bioelectrical impedance analysis (BIA)

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  4. 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

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  5. 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.

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  6. 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].

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  7. Nutritional Assessment

    Evaluation of nutritional state using Mini-Nutritional Assessment (MNA) [range from 1 to 30 score], Korean Protein Assessment Tool (KPAT)

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  8. Handgrip strength

    Evaluation of hand grip strength using Hand-held dynamometer

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  9. Delirium assessment

    Evaluation of delirium using Delirium Rating Scale (DRS) [range from 0 to 32 score]. Higher value means worse delrious status

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  10. 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

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  11. Cognitive assessment

    Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) [range from 0 to 30 score]

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  12. Psychiatric state

    Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) [range from 0 to 30 score]

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  13. Swallowing assessment

    measured by Standardized Swallowing Assessment (SSA)

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

  14. Empowerment assessment

    measured by Korean version of Health Empowerment Scale (K-HES) [range from 8 to 40 score]. Higher value means better empowerment status

    Measured: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2021
  2. Study start8 Mar 2022
  3. Primary completion11 Jul 2024
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04948736
Sponsor's protocol ID
B-2010/645-005
Acronym
MENTORS
Status last verified
Sep 2025
First submitted
21 Jun 2021
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30498820
  • 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.

    PubMed 30312372
  • 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.

    PubMed 32033882
  • 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.

    PubMed 32743250
  • 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.

    PubMed 28539168
  • 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.

    PubMed 28935775
  • 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.

    PubMed 37451728

Questions about this trial

What is this clinical trial studying?

A study testing Combined exercise and nutrition intervention and Conventional medial care in people with Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-times chair stand test (time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04948736, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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MENTORS Clinical Trial NCT04948736 | AzTrials