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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935319
• Other study ID #: Huang Xin-en
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: JiaJie Wang
• Phone: 0965073193
• Email: mswing97[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Function
• Frailty
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
Taiwan	WangJiaJie	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand Grip	Grip strength defined as <28 kg for men and <18 kg for women	1-2 minutes
Primary	Short Physical Performance Battery(SPPB)	?9 points abnormal, 10-12 normal.	5-10 minutes
Primary	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
Primary	Instrumental Activities of Daily Living(IADL)	The full score is 8 points, the higher the score, the better the function.	2-5 minutes
Primary	Mini-Mental State Examination(MMSE)	junior high school ? 24 points, elementary school ? 21 points, those without education ? 16 points.	10-20 minutes
Primary	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