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NCT Number: NCT04777279

Physical Exercise, Nutrition Supplement and Frailty of 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

individual physical exercise group

Behavioral

The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.

individual Branched-Chain Amino Acids supplements group

Dietary Supplement

The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.

combination of physical exercise and nutrition supplements group

Other

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.

Primary outcomes

  1. frailty score

    Time frame: frailty score at baseline

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

  2. 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

Secondary outcomes

  1. 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

  2. Depressive symptoms score

    Time frame: through study completion, an average of 12 weeks

    Depression will measured using Geriatric Depression Scale-15.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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