Physical Exercise, Nutrition Supplement and Frailty of Older Population

Study Overview
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Brief Summary
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This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population.

Detailed Description
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Objective: This study is aimed to explore the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life in community-dwelling older population. Methods: We conduct a quasi-experimental study to measure frailty, depressive symptoms, and quality of life before and after intervention. A total of 120 community-living older adults with frailty identified by Fried's phenotype method are assigned to four groups: physical exercise group, nutrition supplements group, physical exercise and nutrition supplements group, and control group. Each participants in the assigned group will receive 12 weeks intervention. Measurements include frailty (Fried's phenotype method), depressive symptoms (Geriatric Depression Scale-15, GDS-15), and quality of life (WHOQOL-BREF). Data analyses include describe statistics, Chi-square test, and Analysis of Variance. A Generalized estimating equations (GEE) will be used to examine the effect of physical exercise and nutrition supplement on improving frailty, depressive symptoms, and quality of life.

Official Title
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Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population

Conditions
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Sarcopenia, Physical Exercise, Nutrition Poor, Elderly

Intervention / Treatment
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* Behavioral: individual physical exercise group
* Dietary Supplement: individual Branched-Chain Amino Acids supplements group
* Other: combination of physical exercise and nutrition supplements group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older adults aged more than 60 years; pre-frail stage: must have one item as frailty identified using the Fried's phenotype method; normal cognition: AD8 score less than 2 points; can communicate with Mandarin or Taiwanese. Exclusion Criteria: incapable of walk independent or using assistive devices (e.g., crutches); a condition of having an acute disease, hemodialysis, or unable to engage in physical activity; have history of unstable heart disease such as coronary heart disease, heart failure and hypertension without regular medication; have regular physical activity (≥150 minutes weekly) such as aerobic dance, swimming, Tai Chi.

Ages Eligible for Study
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Minimum Age: 60 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual physical exercise group<br>a 12-weeks physical exercise program (60 minutes/ three times weekly) | Behavioral: individual physical exercise group<br>* The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.<br>|
| Experimental: Individual Branched-Chain Amino Acids supplements group<br>a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) | Dietary Supplement: individual Branched-Chain Amino Acids supplements group<br>* The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.<br>|
| Experimental: Combination of physical exercise and Branched-Chain Amino Acids supplements group<br>a 12-weeks physical exercise program (60 minutes/ three times weekly) and a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day) | Other: combination of physical exercise and nutrition supplements group<br>* The participants in physical exercise group will receiving physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks and 5 g Branched-Chain Amino Acids every day for 12 weeks.<br>|
| No Intervention: Control group<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frailty score | Frailty will examined using Fried's phenotype method and higher score indicates more frailty | frailty score at baseline | 
| frailty score | Frailty will examined using Fried's phenotype method and higher score indicates more frailty | through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms score | Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression | Depressive symptoms at baseline | 
| Depressive symptoms score | Depression will measured using Geriatric Depression Scale-15. | through study completion, an average of 12 weeks | 
| Quality of Life score | Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life | Quality of Life at baseline | 
| Quality of Life score | Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life | through study completion, an average of 12 weeks |