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FrailtyVivifrailNCT07731529

Vivifrail Exercise Program in Nonagenarians: Effects on Function, Muscle, and Cognition

A study testing Vivifrail multicomponent exercise program in people with Frailty and Aging, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This randomized clinical trial investigates the effects of a home-based multicomponent exercise program (Vivifrail) on physical function, muscle morphology, and cognition in community-dwelling adults aged 90 years and older. Read more about this study

Who is it for?
Ages 90 years and older
Conditions the study is for
Frailty, Aging, Cognitive Decline
What is being tested?
Vivifrail multicomponent exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesBrazil
Study dates
29 Jul 2026to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 90 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged 90 years or older
  • Living in the community (own or family home)
  • Able to walk independently or with a walking aid (cane or walker), without third-party assistance
  • Minimum cognitive capacity to understand and perform the exercises (MMSE, education-adjusted cutoffs)
  • Adequate home conditions to perform the program
  • Availability of a family member or caregiver to support the sessions
  • Signed informed consent (with legal guardian assistance when needed)

Who cannot join

  • - Total inability to walk or permanent bedridden condition
  • Severe cognitive impairment preventing safe understanding and execution of exercises
  • Severe orthopedic, neurological, or rheumatological conditions preventing exercise
  • Concurrent participation in another structured exercise program
  • Anticipated unavailability (relocation, planned hospitalization, or institutionalization) during the intervention
  • Refusal to sign informed consent or absence of a legal guardian when required

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil2 sites

  • Hospital de Clínicas de Porto Alegre (HCPA) - Geriatrics outpatient clinic

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Escola de Educação Física, Fisioterapia e Dança (ESEFID/UFRGS) - and participants' homes

    Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Effects of a Multicomponent Exercise Program Based on the Vivifrail Protocol on Functional Capacity, Muscle Morphology, and Cognition in Nonagenarians: A Randomized Clinical Trial

This randomized clinical trial investigates the effects of a home-based multicomponent exercise program (Vivifrail) on physical function, muscle morphology, and cognition in community-dwelling adults aged 90 years and older. Participants are randomized into three groups: Vivifrail at least twice a week, Vivifrail at least three times a week, or a control group. Outcomes are assessed at baseline, 12 weeks, and 24 weeks. The primary outcome is physical function measured by the Short Physical Performance Battery (SPPB).

Read the detailed description

This is a three-arm, parallel-group randomized controlled trial evaluating a home-based multicomponent exercise program based on the Vivifrail protocol in community-dwelling nonagenarians (aged 90 years or older). A total of 54 participants (18 per group) will be randomly allocated to one of three groups: G1, performing the Vivifrail program at least twice a week; G2, performing it at least three times a week; or a control group (GC) maintaining usual activities.

Randomization will be performed using Randomizer software (www.randomizer.org) by an independent researcher not involved in the assessments. Allocation is stratified by sex and by baseline functional level, defined by collapsing the six Vivifrail functional categories into two groups (lower function: Types A, B, and B+; higher function: Types C, C+, and D), to ensure balanced distribution of baseline physical function across the three groups. Each participant is still assigned the individualized Vivifrail training passport corresponding to their specific functional category. Given the autonomous, home-based nature of the intervention, participants and interventionists cannot be blinded; however, outcome assessors remain blinded to group allocation throughout the study.

Assessments occur at three timepoints: baseline (T0), 12 weeks (T1), and 24 weeks (T2). The 24-week intervention is individualized according to each participant's functional profile, determined by the Short Physical Performance Battery (SPPB) and the corresponding Vivifrail training passport.

The primary outcome is physical function measured by the total SPPB score (0-12). Secondary outcomes include mobility (Timed Up and Go and cognitive dual-task cost), handgrip strength, lower-limb power (five-times sit-to-stand with linear encoder), gait speed, balance, muscle morphology of the vastus lateralis (ultrasound), cognition (Mini-Mental State Examination), and change in Vivifrail functional category. Data will be analyzed by intention to treat using generalized estimating equations (GEE), examining the group-by-time interaction.

Being tested
Vivifrail multicomponent exercise program
Keywords
Vivifrail, Multicomponent exercise, Nonagenarians, Physical function, Short Physical Performance Battery, Muscle quality, Muscle morphology, Home-based exercise
Medical subject headings
Frailty, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivifrail multicomponent exercise programBehavioural

    Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.

Study groups in NCT07731529
Study groupRoleWhat they receive
Vivifrail - 2 sessions/week (G1)ExperimentalHome-based Vivifrail multicomponent exercise program performed at least twice a week for 24 weeks, individualized by functional profile (SPPB and Vivifrail passport).
Receives: Behavioral: Vivifrail multicomponent exercise program
Vivifrail - 3 sessions/week (G2)ExperimentalHome-based Vivifrail multicomponent exercise program performed at least three times a week for 24 weeks, individualized by functional profile.
Receives: Behavioral: Vivifrail multicomponent exercise program
Control (GC)No interventionParticipants maintain usual activities without a structured exercise program during the 24-week period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical function measured by the Short Physical Performance Battery (SPPB) total score

    Total SPPB score ranging from 0 to 12 points (higher scores indicate better lower-extremity physical function), combining balance, gait speed, and chair-stand tests.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Secondary outcomes (10)

  1. Mobility - Timed Up and Go (TUG)

    ime in seconds to rise, walk 3 meters, turn, return, and sit.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

  2. Mobility under dual task - Cognitive TUG and dual-task cost (DTC%) ·

    TUG performed with a concurrent cognitive task; dual-task cost calculated as percentage change relative to single-task TUG.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).

  3. Handgrip strength

    Maximal isometric handgrip strength in kilograms, measured with a Jamar dynamometer.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).

  4. Lower-limb muscle power - Five-times sit-to-stand

    ime in seconds and estimated lower-limb power measured during the five-times sit-to-stand test using a linear encoder.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).

  5. Gait speed

    Usual gait speed in meters per second.

    Measured: aseline (T0), 12 weeks (T1), and 24 weeks (T2)).

  6. Balance

    Static balance assessed by the SPPB balance component (side-by-side, semi-tandem, and tandem stands).

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).

  7. Change in Vastus Lateralis Muscle Thickness

    Vastus lateralis muscle thickness measured by B-mode ultrasound, defined as the distance between the adipose-muscle and muscle-bone interfaces, analyzed in ImageJ by a single trained, blinded assessor.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

  8. Change in Vastus Lateralis Echo Intensity (Muscle Quality)

    Muscle quality assessed by echo intensity on B-mode ultrasound, expressed in arbitrary units (grayscale, 0-255) via manual region-of-interest analysis in ImageJ, excluding fascia and bone. Higher echo intensity indicates greater intramuscular fat/fibrous infiltration, i.e., poorer muscle quality. Single assessor blinded to group allocation.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

  9. Cognition - Mini-Mental State Examination (MMSE)

    Global cognitive function measured by the MMSE, using education-adjusted cutoffs.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

  10. Change in Vivifrail functional category

    Transition across Vivifrail functional categories (Types A, B, B+, C, C+, D) over the intervention period.

    Measured: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start29 Jul 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07731529
Sponsor's protocol ID
79748517.5.0000.5347
Other IDs
U1111-1343-8083
Acronym
Vivifrail
Status last verified
Sep 2026
First submitted
20 Jul 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Vivifrail multicomponent exercise program in people with Frailty and Aging, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.

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 7 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in physical function measured by the Short Physical Performance Battery (SPPB) total score (time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07731529.

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 3 Sep 2026.

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Vivifrail Clinical Trial NCT07731529 | AzTrials