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

Primary Purpose

Frailty, Physical Activity, Cognitive Function

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vivifrail
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ≧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. Exclusion Criteria: Those who cannot cooperate with the interventional care plan. Elderly who are seriously ill or terminally ill. People living in institutions. 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).

Sites / Locations

  • WangJiaJieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

Vivifrail

Traditional Sports Health Leaflet

Outcomes

Primary Outcome Measures

Hand Grip
Grip strength defined as <28 kg for men and <18 kg for women
Short Physical Performance Battery(SPPB)
≦9 points abnormal, 10-12 normal.
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.
Instrumental Activities of Daily Living(IADL)
The full score is 8 points, the higher the score, the better the function.
Mini-Mental State Examination(MMSE)
junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.
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.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
June 28, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05935319
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Physical Activity, Cognitive Function

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Vivifrail
Arm Title
control group
Arm Type
No Intervention
Arm Description
Traditional Sports Health Leaflet
Intervention Type
Other
Intervention Name(s)
Vivifrail
Intervention Description
Assess the physical activity status of the elderly, use the Vivifrail grade, provide exercise intervention, and improve physical activity function.
Primary Outcome Measure Information:
Title
Hand Grip
Description
Grip strength defined as <28 kg for men and <18 kg for women
Time Frame
1-2 minutes
Title
Short Physical Performance Battery(SPPB)
Description
≦9 points abnormal, 10-12 normal.
Time Frame
5-10 minutes
Title
Activities of Daily Living(ADL)
Description
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.
Time Frame
2-5 minutes
Title
Instrumental Activities of Daily Living(IADL)
Description
The full score is 8 points, the higher the score, the better the function.
Time Frame
2-5 minutes
Title
Mini-Mental State Examination(MMSE)
Description
junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.
Time Frame
10-20 minutes
Title
Geriatric Depression Scale(GDS- 15)
Description
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.
Time Frame
10-20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≧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. Exclusion Criteria: Those who cannot cooperate with the interventional care plan. Elderly who are seriously ill or terminally ill. People living in institutions. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JiaJie Wang
Phone
0965073193
Email
mswing97@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin-en Huang
Organizational Affiliation
Host
Official's Role
Principal Investigator
Facility Information:
Facility Name
WangJiaJie
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiaJie
Phone
0965073193
Email
mswing97@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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