Physical Exercise, Nutrition Supplement and Frailty of Older Population

March 22, 2022 updated by: Huang, Hui-Chuan, Taipei Medical University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frailty score
Time Frame: frailty score at baseline
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
frailty score at baseline
frailty score
Time Frame: through study completion, an average of 12 weeks
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
Time Frame: Depressive symptoms at baseline
Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression
Depressive symptoms at baseline
Depressive symptoms score
Time Frame: through study completion, an average of 12 weeks
Depression will measured using Geriatric Depression Scale-15.
through study completion, an average of 12 weeks
Quality of Life score
Time Frame: Quality of Life at baseline
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
Time Frame: 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
through study completion, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on individual physical exercise group

3
Subscribe