FrailtyNCT06975449
Effectiveness of Graded Training in the Vivifrail Exercise Program Among Long-Term Care Residents
A study testing Multicomponent Physical Exercise Program (Vivifrail) in people with Frailty and Physical Inactivity, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study evaluates the effectiveness of the Vivifrail multicomponent physical exercise program among elderly residents with different levels of frailty in long-term care centers. A 12-week intervention will be conducted in randomly assigned experimental and control groups. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Physical Inactivity, Aging
- What is being tested?
- Multicomponent Physical Exercise Program (Vivifrail)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2025to 20 Feb 2026
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥70, resident in LTC center, ambulatory, physician-cleared for training
Who cannot join
- Conditions listed in Vivifrail exclusion criteria (e.g., acute MI, unstable angina, recent fractures, uncontrolled hypertension, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Graded Training in the Multicomponent Vivifrail Exercise Program Among Residents of Long-Term Care Facilities: A Randomized Controlled Trial
This study evaluates the effectiveness of the Vivifrail multicomponent physical exercise program among elderly residents with different levels of frailty in long-term care centers. A 12-week intervention will be conducted in randomly assigned experimental and control groups. Outcomes include physical performance, fall risk, grip strength, calf circumference, and ICOPE function.
- Conditions
- Frailty, Physical Inactivity, Aging
- Being tested
- Multicomponent Physical Exercise Program (Vivifrail)
- Medical subject headings
- Frailty, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Physical Exercise Program (Vivifrail)Behavioural
Vivifrail physical training, 5 times/week, 50-60 minutes/session for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Usual Care | Active comparator | Participants in this group will receive usual care with no structured physical activity program. They will continue their normal daily routines and have access to health education materials unrelated to physical activity. Receives: Behavioral: Multicomponent Physical Exercise Program (Vivifrail) |
| Intervention Group: Multicomponent Physical Activity Program (Vivifrail) | Experimental | Participants in this arm will receive a 12-week multicomponent physical activity program based on the Vivifrail protocol, designed to improve physical function and reduce frailty in older adults. The intervention includes individualized exercise sessions incorporating strength, balance, flexibility, and endurance training, adjusted according to baseline functional capacity. Sessions are supervised by trained personnel and conducted three times per week in a community or long-term care setting. The program also includes educational components promoting adherence and safe exercise practices. Receives: Behavioral: Multicomponent Physical Exercise Program (Vivifrail) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
Measured: SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Measured: Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Secondary outcomes (2)
ICOPE function assessment at Weeks 0, 12, 24
ICOPE function assessment at Weeks 0, 12, 24
Measured: ICOPE function assessment at Weeks 0, 12, 24
Grip strength (hand dynamometer) at Weeks 0, 12, 24
Grip strength (hand dynamometer) at Weeks 0, 12, 24
Measured: Grip strength (hand dynamometer) at Weeks 0, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 May 2025
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Hua Lu, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975449
- Sponsor's protocol ID
- CMUH114-REC3-034
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 24 Mar 2026
- 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Graded Training in the Multicomponent Vivifrail Exercise Program Among Residents of Long-Term Care Facilities: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06975449
- Acronym / sponsor ID
- CMUH114-REC3-034
- Conditions
- Frailty, Physical Inactivity, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 16 May 2025 (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.
This study evaluates the effectiveness of the Vivifrail multicomponent physical exercise program among elderly residents with different levels of frailty in long-term care centers. A 12-week intervention will be conducted in randomly assigned experimental and control groups. Outcomes include physical performance, fall risk, grip strength, calf circumference, and ICOPE function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Usual Care | Active comparator | Behavioral: Multicomponent Physical Exercise Program (Vivifrail)Participants in this group will receive usual care with no structured physical activity program. They will continue their normal daily routines and have access to health education materials unrelated to physical activity. |
| Intervention Group: Multicomponent Physical Activity Program (Vivifrail) | Experimental | Behavioral: Multicomponent Physical Exercise Program (Vivifrail)Participants in this arm will receive a 12-week multicomponent physical activity program based on the Vivifrail protocol, designed to improve physical function and reduce frailty in older adults. The intervention includes individualized exercise sessions incorporating strength, balance, flexibility, and endurance training, adjusted according to baseline functional capacity. Sessions are supervised by trained personnel and conducted three times per week in a community or long-term care setting. The program also includes educational components promoting adherence and safe exercise practices. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age ≥70, resident in LTC center, ambulatory, physician-cleared for training
Key exclusion criteria (1 listed)
- Conditions listed in Vivifrail exclusion criteria (e.g., acute MI, unstable angina, recent fractures, uncontrolled hypertension, etc.)
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 |
|---|---|---|
| Multicomponent Physical Exercise Program (Vivifrail)Vivifrail physical training, 5 times/week, 50-60 minutes/session for 12 weeks | Behavioural | Control Group: Usual Care, Intervention Group: Multicomponent Physical Activity Program (Vivifrail) |
Primary outcome
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
Time frame: SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24
Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Time frame: Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
Fall risk assessment (TUG, gait speed, number of falls) at Weeks 0, 4, 8, 12, 16, 20, 24
2 secondary outcomes
ICOPE function assessment at Weeks 0, 12, 24
Time frame: ICOPE function assessment at Weeks 0, 12, 24
Grip strength (hand dynamometer) at Weeks 0, 12, 24
Time frame: Grip strength (hand dynamometer) at Weeks 0, 12, 24
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 24 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Physical Exercise Program (Vivifrail) in people with Frailty and Physical Inactivity, run by China Medical University Hospital 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 1 inclusion and 1 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 24 Mar 2026. 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?
SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24 (time frame: SPPB Score change at Weeks 0, 4, 8, 12, 16, 20, 24). The study lists 2 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 24 Mar 2026.