Clinical trial NCT05935319: VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
Official title: The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Physical Activity
Cognitive Function
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Hand Grip
timeFrame: 1-2 minutes
measure: Short Physical Performance Battery(SPPB)
timeFrame: 5-10 minutes
measure: Activities of Daily Living(ADL)
timeFrame: 2-5 minutes
measure: Instrumental Activities of Daily Living(IADL)
timeFrame: 2-5 minutes
measure: Mini-Mental State Examination(MMSE)
timeFrame: 10-20 minutes
measure: Geriatric Depression Scale(GDS- 15)
timeFrame: 10-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: WangJiaJie
Study officials:
affiliation: Host
name: Xin-en Huang
role: PRINCIPAL_INVESTIGATOR
References: