Physical Exercise, Nutrition Supplement and Frailty of Older Population
Primary Purpose
Sarcopenia, Physical Exercise, Nutrition Poor
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
individual physical exercise group
individual Branched-Chain Amino Acids supplements group
combination of physical exercise and nutrition supplements group
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Individual physical exercise group
Individual Branched-Chain Amino Acids supplements group
Combination of physical exercise and Branched-Chain Amino Acids supplements group
Control group
Arm Description
a 12-weeks physical exercise program (60 minutes/ three times weekly)
a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day)
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)
no intervention
Outcomes
Primary Outcome Measures
frailty score
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
frailty score
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
Secondary Outcome Measures
Depressive symptoms score
Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression
Depressive symptoms score
Depression will measured using Geriatric Depression Scale-15.
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 score
Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Full Information
NCT ID
NCT04777279
First Posted
January 26, 2021
Last Updated
March 22, 2022
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04777279
Brief Title
Physical Exercise, Nutrition Supplement and Frailty of Older Population
Official Title
Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Physical Exercise, Nutrition Poor, Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individual physical exercise group
Arm Type
Experimental
Arm Description
a 12-weeks physical exercise program (60 minutes/ three times weekly)
Arm Title
Individual Branched-Chain Amino Acids supplements group
Arm Type
Experimental
Arm Description
a 12-weeks Branched-Chain Amino Acids supplements (5 g Branched-Chain Amino Acids every day)
Arm Title
Combination of physical exercise and Branched-Chain Amino Acids supplements group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
individual physical exercise group
Intervention Description
The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
individual Branched-Chain Amino Acids supplements group
Intervention Description
The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
combination of physical exercise and nutrition supplements group
Intervention Description
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 Outcome Measure Information:
Title
frailty score
Description
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
Time Frame
frailty score at baseline
Title
frailty score
Description
Frailty will examined using Fried's phenotype method and higher score indicates more frailty
Time Frame
through study completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms score
Description
Depression will measured using Geriatric Depression Scale-15 (GDS-15) and and higher score indicates more depression
Time Frame
Depressive symptoms at baseline
Title
Depressive symptoms score
Description
Depression will measured using Geriatric Depression Scale-15.
Time Frame
through study completion, an average of 12 weeks
Title
Quality of Life score
Description
Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Time Frame
Quality of Life at baseline
Title
Quality of Life score
Description
Quality of Life will examined using World Health Organization Quality of Life scale and higher score indicate better quality of life
Time Frame
through study completion, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Physical Exercise, Nutrition Supplement and Frailty of Older Population
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