Physical Exercise, Nutrition Supplement and Frailty of Older Population

NCT04777279 | Completed

• 1 other identifier: N202010046
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Physical Exercise; Nutrition Poor; Elderly

Outcome Measures

Primary Outcomes (2)

• frailty score

  Frailty will examined using Fried's phenotype method and higher score indicates more frailty

  frailty score at baseline

• frailty score

  Frailty will examined using Fried's phenotype method and higher score indicates more frailty

  through study completion, an average of 12 weeks

Secondary Outcomes (4)

• Depressive symptoms score

  Depressive symptoms at baseline

• Depressive symptoms score

  through study completion, an average of 12 weeks

• Quality of Life score

  Quality of Life at baseline

• Quality of Life score

  through study completion, an average of 12 weeks

Study Arms (4)

Individual physical exercise group

EXPERIMENTAL

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

Behavioral: individual physical exercise group

Individual Branched-Chain Amino Acids supplements group

EXPERIMENTAL

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

Dietary Supplement: individual Branched-Chain Amino Acids supplements group

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

EXPERIMENTAL

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)

Other: combination of physical exercise and nutrition supplements group

Control group

NO INTERVENTION

no intervention

Interventions

individual physical exercise group 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 physical exercise group

individual Branched-Chain Amino Acids supplements group 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.

Individual Branched-Chain Amino Acids supplements group

combination of physical exercise and nutrition supplements group 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.

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 37018848 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity; Malnutrition

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hui-Chuan Huang, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: March 2, 2021
• Study Start: December 9, 2020
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)