Physical Exercise, Nutrition Supplement and Frailty of Older Population

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777279
• Other study ID #: N202010046
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Elderly
• Frailty
• Malnutrition
• Nutrition Poor
• Physical Exercise
• Sarcopenia

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