Physical Exercise, Nutrition Supplement and Frailty of Older Population

NCT ID: NCT04777279

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-08-30

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.

Conditions

Sarcopenia; Physical Exercise; Nutrition Poor; Elderly

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Individual physical exercise group

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

Group Type: EXPERIMENTAL

individual physical exercise group

Intervention Type: 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

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

Group Type: EXPERIMENTAL

individual Branched-Chain Amino Acids supplements group

Intervention Type: 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 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)

Group Type: EXPERIMENTAL

combination of physical exercise and nutrition supplements group

Intervention Type: 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.

Control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

individual physical exercise group

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: BEHAVIORAL

individual Branched-Chain Amino Acids supplements group

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: DIETARY_SUPPLEMENT

combination of physical exercise and nutrition supplements group

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huang, Hui-Chuan

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Chuan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

References

Chen LF, Chang HC, Cai ZC, Chen YJ, Hsu WL, Chuang YH, Lee SC, Huang HC. Community-based exercise and nutritional interventions to improve frailty syndrome among older adults: A quasi-experimental study. Geriatr Nurs. 2023 May-Jun;51:222-231. doi: 10.1016/j.gerinurse.2023.03.016. Epub 2023 Apr 3.

Reference Type: DERIVED

PMID: 37018848 (View on PubMed)

Other Identifiers

N202010046

Identifier Type: -

Identifier Source: org_study_id