- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777279
Physical Exercise, Nutrition Supplement and Frailty of Older Population
Physical Exercise and Nutrition Supplement on Improving Frailty, Depressive Symptoms, and Quality of Life in Community-dwelling Older Population
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 110
- Taipei Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202010046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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