Physical Exercise, Nutrition Supplement and Frailty of Older Population

Taipei Medical University

Status: Completed

Conditions: Elderly; Physical Exercise; Sarcopenia; Nutrition Poor

Treatments: Behavioral: individual physical exercise group; Other: combination of physical exercise and nutrition supplements group; Dietary Supplement: individual Branched-Chain Amino Acids supplements group

Study type: Interventional

Funder types: Other

Identifiers

NCT04777279

N202010046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 4 patient groups

Individual physical exercise group

Experimental group

Description:

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

Treatment:

Behavioral: individual physical exercise group

Individual Branched-Chain Amino Acids supplements group

Experimental group

Description:

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

Treatment:

Dietary Supplement: individual Branched-Chain Amino Acids supplements group

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

Experimental group

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)

Treatment:

Other: combination of physical exercise and nutrition supplements group

Control group

No Intervention group

Description:

no intervention