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

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05935319
Collaborator
(none)
200
1
2
10.2
19.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Vivifrail
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
Actual Study Start Date :
May 26, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

Vivifrail

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

No Intervention: control group

Traditional Sports Health Leaflet

Outcome Measures

Primary Outcome Measures

  1. Hand Grip [1-2 minutes]

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

  2. Short Physical Performance Battery(SPPB) [5-10 minutes]

    ≦9 points abnormal, 10-12 normal.

  3. Activities of Daily Living(ADL) [2-5 minutes]

    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.

  4. Instrumental Activities of Daily Living(IADL) [2-5 minutes]

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

  5. Mini-Mental State Examination(MMSE) [10-20 minutes]

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

  6. Geriatric Depression Scale(GDS- 15) [10-20 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. ≧65 years old and above.

  2. Pre-frail and frail cases assessed by Frail Fried's frail phenotype.

  3. Clear consciousness, willing to accept interviewers, able to communicate in Chinese and Taiwanese.

  4. Those who can cooperate with physical activities and have ADL ≥ 60 points.

Exclusion Criteria:
  1. Those who cannot cooperate with the interventional care plan.

  2. Elderly who are seriously ill or terminally ill.

  3. People living in institutions.

  4. Incompatibility and exclusion: acute myocardial infarction or recent unstable angina, poorly controlled atrial or ventricular arrhythmia, dissected aortic aneurysm, severe aortic stenosis, endocarditis/acute cardiac Capsulitis, uncontrolled hypertension, acute thromboembolism, acute or severe heart failure, acute or severe respiratory failure, uncontrolled postural hypotension, acute incompensated diabetes mellitus, or uncontrolled hypoglycemia, past month There is a fracture (muscle strength training).

Contacts and Locations

Locations

Site City State Country Postal Code
1 WangJiaJie Hualien City Taiwan 970

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences

Investigators

  • Principal Investigator: Xin-en Huang, Host

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
WangJiaJie, Principal Investigator, Mennonite Christian Hospital
ClinicalTrials.gov Identifier:
NCT05935319
Other Study ID Numbers:
  • Huang Xin-en
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023