FrailtyNCT05935319
VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
A study testing Vivifrail in people with Frailty and Physical Activity, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Physical Activity, Cognitive Function
- What is being tested?
- Vivifrail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 May 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≧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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
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.
- Conditions
- Frailty, Physical Activity, Cognitive Function
- Being tested
- Vivifrail
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivifrailOther
Assess the physical activity status of the elderly, use the Vivifrail grade, provide exercise intervention, and improve physical activity function.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Vivifrail Receives: Other: Vivifrail |
| control group | No intervention | Traditional Sports Health Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip
Grip strength defined as <28 kg for men and <18 kg for women
Measured: 1-2 minutes
Short Physical Performance Battery(SPPB)
≦9 points abnormal, 10-12 normal.
Measured: 5-10 minutes
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.
Measured: 2-5 minutes
Instrumental Activities of Daily Living(IADL)
The full score is 8 points, the higher the score, the better the function.
Measured: 2-5 minutes
Mini-Mental State Examination(MMSE)
junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.
Measured: 10-20 minutes
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.
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start26 May 2023
- Primary completion31 Oct 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WangJiaJie, Mennonite Christian Hospital
- Investigators
- Xin-en Huang, Principal investigator, Host
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935319
- Sponsor's protocol ID
- Huang Xin-en
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a VIVIFRAIL Program in Improving the Frailty and Physical Function in the Elderly
- ClinicalTrials.gov ID
- NCT05935319
- Acronym / sponsor ID
- Huang Xin-en
- Conditions
- Frailty, Physical Activity, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: VivifrailVivifrail |
| control group | No intervention | –Traditional Sports Health Leaflet |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≧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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VivifrailAssess the physical activity status of the elderly, use the Vivifrail grade, provide exercise intervention, and improve physical activity function. | Other | experimental group |
Primary outcome
Hand Grip
Time frame: 1-2 minutes
Grip strength defined as <28 kg for men and <18 kg for women
Short Physical Performance Battery(SPPB)
Time frame: 5-10 minutes
≦9 points abnormal, 10-12 normal.
Activities of Daily Living(ADL)
Time frame: 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.
Instrumental Activities of Daily Living(IADL)
Time frame: 2-5 minutes
The full score is 8 points, the higher the score, the better the function.
Mini-Mental State Examination(MMSE)
Time frame: 10-20 minutes
junior high school ≧ 24 points, elementary school ≧ 21 points, those without education ≧ 16 points.
Geriatric Depression Scale(GDS- 15)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin-en Huang principal investigator
Host
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivifrail in people with Frailty and Physical Activity, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Grip (time frame: 1-2 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.