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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04777279
Other study ID # N202010046
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 9, 2020
Est. completion date August 30, 2021

Study information

Verified date March 2022
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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


Intervention

Behavioral:
individual physical exercise group
The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.
Dietary Supplement:
individual Branched-Chain Amino Acids supplements group
The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.
Other:
combination of physical exercise and nutrition supplements group
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.

Locations

Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary frailty score Frailty will examined using Fried's phenotype method and higher score indicates more frailty frailty score at baseline
Primary 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 Depressive symptoms score Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression Depressive symptoms at baseline
Secondary Depressive symptoms score Depression will measured using Geriatric Depression Scale-15. through study completion, an average of 12 weeks
Secondary 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
Secondary 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
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