Skip to content

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

The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05935319
Enrollment
200
Registered
2023-07-07
Start date
2023-05-26
Completion date
2025-03-31
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Frailty, Physical Activity

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.

Interventions

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

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frameDescription
Hand Grip1-2 minutesGrip strength defined as \<28 kg for men and \<18 kg for women
Short Physical Performance Battery(SPPB)5-10 minutes≦9 points abnormal, 10-12 normal.
Activities of Daily Living(ADL)2-5 minutesThe 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.
Instrumental Activities of Daily Living(IADL)2-5 minutesThe full score is 8 points, the higher the score, the better the function.
Mini-Mental State Examination(MMSE)10-20 minutesjunior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.
Geriatric Depression Scale(GDS- 15)10-20 minutesThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026