Physical Exercise, Nutrition Supplement and Frailty of Older Population

Not Applicable

Completed

• Conditions: Elderly; Physical Exercise; Sarcopenia; Nutrition Poor
• Interventions: Other: combination of physical exercise and nutrition supplements group; Dietary Supplement: individual Branched-Chain Amino Acids supplements group; Behavioral: individual physical exercise group

• Registration Number: NCT04777279
• Lead Sponsor: Taipei Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-09
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of physical exercise and Branched-Chain Amino Acids supplements group	combination of physical exercise and nutrition supplements group	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)
Individual Branched-Chain Amino Acids supplements group	individual Branched-Chain Amino Acids supplements group	a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day)
Individual physical exercise group	individual physical exercise group	a 12-weeks physical exercise program (60 minutes/ three times weekly)

Primary Outcome Measures

Name	Time	Method
frailty score	through study completion, an average of 12 weeks	Frailty will examined using Fried's phenotype method and higher score indicates more frailty

Secondary Outcome Measures

Name	Time	Method
Quality of Life score	through study completion, an average of 12 weeks	Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Depressive symptoms score	through study completion, an average of 12 weeks	Depression will measured using Geriatric Depression Scale-15.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan