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Clinical Trials/NCT04777279
NCT04777279CompletedNot Applicable

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

Taipei Medical University1 site in 1 country120 target enrollmentStarted: December 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
frailty score

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Individual physical exercise group

Experimental

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

Intervention: individual physical exercise group (Behavioral)

Individual Branched-Chain Amino Acids supplements group

Experimental

a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day)

Intervention: individual Branched-Chain Amino Acids supplements group (Dietary Supplement)

Combination of physical exercise and Branched-Chain Amino Acids supplements group

Experimental

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)

Intervention: combination of physical exercise and nutrition supplements group (Other)

Control group

No Intervention

no intervention

Outcomes

Primary Outcomes

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

frailty score

Time Frame: frailty score at baseline

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

Secondary Outcomes

  • Quality of Life score(through study completion, an average of 12 weeks)
  • Depressive symptoms score(through study completion, an average of 12 weeks)
  • Depressive symptoms score(Depressive symptoms at baseline)
  • Quality of Life score(Quality of Life at baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Huang, Hui-Chuan

associate professor

Taipei Medical University

Study Sites (1)

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