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Completed

NCT Number: NCT07028294

Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia (2)

This is an empirical study, which aims to examine the effect of a 12-week combined exercise-nutrition intervention in older adults with sarcopenia and to provide data for clinical and policy decision-making of sarcopenia. The study conducts the combined exercise-nutrition intervention that was previously carried out as a randomized controlled trial. Hand grip 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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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 has recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. However, the standard protocol for the combined exercise-nutrition intervention has not been established yet. Therefore, this study aims to see the effects of a 12-week combined exercise-nutrition intervention in sarcopenia patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined exercise and nutrition intervention

Combination 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.

Primary outcomes

  1. 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)

    Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test

Secondary outcomes

  1. Physical performance

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

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

  2. Gait speed test

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

    measured by 6 meter gait speed

  3. Appendicular skeletal muscle mass

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

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

  4. Health Related Quality of Life

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

    Evaluation of quality of life using EQ-5D [range from 5 to 25 score]. Higher value means worse quality of life

  5. Basic and instrumental activities of daily living

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

    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.

  6. Sarcopenia screening questionnaire

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

    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].

  7. Nutritional Assessment

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

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

  8. Handgrip strength

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

    Evaluation of hand grip strength using Hand-held dynamometer

  9. Delirium assessment

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

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

  10. Physical acitivity assessment

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

    Measured by Korean Physical Activity Scale for the Elderly (K-PASE) [range from 0 to 1382.52 score]. Higher value means better physical status

  11. Cognitive assessment

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

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

  12. Psychiatric state

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

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

  13. Swallowing assessment

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

    measured by Standardized Swallowing Assessment (SSA)

  14. Empowerment assessment

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

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Effectiveness and Clinical Application of Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenic Older Adults With Metabolic Syndrome: Multicenter Empirical Study

Acronym: MENTORS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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