Physical Exercise, Nutrition Supplement and Frailty of Older Population

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04777279
Collaborator
(none)
120
1
4
8.7
13.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: individual physical exercise group
  • Dietary Supplement: individual Branched-Chain Amino Acids supplements group
  • Other: combination of physical exercise and nutrition supplements group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population
Actual Study Start Date :
Dec 9, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Individual physical exercise group

a 12-weeks physical exercise program (60 minutes/ three times weekly)

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.

Experimental: Individual Branched-Chain Amino Acids supplements group

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
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)

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.

No Intervention: Control group

no intervention

Outcome Measures

Primary Outcome Measures

  1. frailty score [frailty score at baseline]

    Frailty will examined using Fried's phenotype method and higher score indicates more frailty

  2. 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

  1. Depressive symptoms score [Depressive symptoms at baseline]

    Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression

  2. Depressive symptoms score [through study completion, an average of 12 weeks]

    Depression will measured using Geriatric Depression Scale-15.

  3. Quality of Life score [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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan 110

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Hui-Chuan Huang, PhD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huang, Hui-Chuan, associate professor, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT04777279
Other Study ID Numbers:
  • N202010046
First Posted:
Mar 2, 2021
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022