Clinical trial NCT04777279: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Physical Exercise
Nutrition Poor
Elderly
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: frailty score
timeFrame: frailty score at baseline
measure: frailty score
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Depressive symptoms score
timeFrame: Depressive symptoms at baseline
measure: Depressive symptoms score
timeFrame: through study completion, an average of 12 weeks
measure: Quality of Life score
timeFrame: Quality of Life at baseline
measure: Quality of Life score
timeFrame: through study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Hui-Chuan Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: