VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

NCT05935319 | Completed

• 1 other identifier: Huang Xin-en
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The global population is aging, and Taiwan has become an aging society. The aging population continues to rise. When the physical function and mental state of the elderly gradually decline, it is easy for the elderly to enter a state of physical weakness. Weakness is the decline in the reserve capacity of the physiological system. It is also related to geriatric syndrome, causing falls, hospitalization, disability, death, and increased medical costs, burden on primary caregivers, and reduced quality of life for the elderly. Physical exercise training has been considered to be an effective strategy to prevent and delay disability and frailty, so this study uses the Vivifrail program for the elderly. A family-based 12-week exercise program, including: resistance, strength, balance, flexibility and cardiorespiratory endurance exercise training, performed five days a week, at least 45-60 minutes each time, so that the elderly can exercise at home, It can also improve physical function and improve the quality of life. This study adopts a randomized controlled trial (RCT) with a one-group pretest-posttest design, with pre-frail and frail elderly as the research objects, and uses comprehensive assessment of the elderly to understand the physical function of the elderly Status, Vivifrail for the elderly was provided for abnormal physical function items, and post-test evaluation was carried out 4 weeks and 12 weeks after the intervention. In Taiwan, there is no research on Vivifrail for the frail elderly. In view of this, it is hoped that through the Vivifrail program and the follow-up of case managers, multi-faceted and continuous integrated care can be provided. Improve and maintain the physical function of the frail elderly for reference in the daily care of the elderly in the future.

Conditions

Frailty; Physical Activity; Cognitive Function

Outcome Measures

Primary Outcomes (6)

• Hand Grip

  Grip strength defined as \<28 kg for men and \<18 kg for women

  1-2 minutes

• Short Physical Performance Battery(SPPB)

  ≦9 points abnormal, 10-12 normal.

  5-10 minutes

• Activities of Daily Living(ADL)

  The full score is 100 points, 0-20 points are completely dependent, 21-60 points are heavily dependent, 61-90 points are moderately dependent, 91-99 points are slightly dependent, and 100 points are completely independent.

  2-5 minutes

• Instrumental Activities of Daily Living(IADL)

  The full score is 8 points, the higher the score, the better the function.

  2-5 minutes

• Mini-Mental State Examination(MMSE)

  junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.

  10-20 minutes

• Geriatric Depression Scale(GDS- 15)

  The full score is 15 points, 0-4 points are normal, 5-9 points are mild depression, 10-14 points are moderate depression, and more than 15 points are depression.

  10-20 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

Vivifrail

Other: Vivifrail

control group

NO INTERVENTION

Traditional Sports Health Leaflet

Interventions

Vivifrail OTHER

Assess the physical activity status of the elderly, use the Vivifrail grade, provide exercise intervention, and improve physical activity function.

experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≧65 years old and above.
• Pre-frail and frail cases assessed by Frail Fried's frail phenotype.
• Clear consciousness, willing to accept interviewers, able to communicate in Chinese and Taiwanese.
• Those who can cooperate with physical activities and have ADL ≥ 60 points.

You may not qualify if:

• Those who cannot cooperate with the interventional care plan.
• Elderly who are seriously ill or terminally ill.
• People living in institutions.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

WangJiaJie

Hualien City, 970, Taiwan

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Xin-en Huang

  Host

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 7, 2023
• Study Start: May 26, 2023
• Primary Completion: October 31, 2024
• Study Completion: March 31, 2025
• Last Updated: July 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)