Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia

Study Overview
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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.

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.

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Combination Product: Combined exercise and nutrition intervention
* Other: Conventional medial care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined exercise nutrition intervention group<br>Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period. | Combination Product: Combined exercise and nutrition intervention<br>* 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.<br>|
| Active Comparator: Conventional medial care group<br>Conventional medical care service for 12weeks during intervention period. | Other: Conventional medial care<br>* 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.<br>|

What is the study measuring?
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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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention