Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined exercise nutrition intervention group

Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period.

Group Type EXPERIMENTAL

Combined exercise and nutrition intervention

Intervention Type 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.

Conventional medial care group

Conventional medical care service for 12weeks during intervention period.

Group Type ACTIVE_COMPARATOR

Conventional medial care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No