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

September 1, 2026 updated by: Alessandra Quadros, Federal University of Rio Grande do Sul

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre (HCPA) - Geriatrics outpatient clinic
      • Porto Alegre, Rio Grande do Sul, Brazil, 90690-200
        • Escola de Educação Física, Fisioterapia e Dança (ESEFID/UFRGS) - and participants' homes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vivifrail - 2 sessions/week (G1)
Home-based Vivifrail multicomponent exercise program performed at least twice a week for 24 weeks, individualized by functional profile (SPPB and Vivifrail passport).
Behavioral: Vivifrail multicomponent exercise program
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
Experimental: Vivifrail - 3 sessions/week (G2)
Home-based Vivifrail multicomponent exercise program performed at least three times a week for 24 weeks, individualized by functional profile.
Behavioral: Vivifrail multicomponent exercise program
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
No Intervention: Control (GC)
Participants maintain usual activities without a structured exercise program during the 24-week period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mobility - Timed Up and Go (TUG)
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
ime in seconds to rise, walk 3 meters, turn, return, and sit.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Mobility under dual task - Cognitive TUG and dual-task cost (DTC%) ·
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
TUG performed with a concurrent cognitive task; dual-task cost calculated as percentage change relative to single-task TUG.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Handgrip strength
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Maximal isometric handgrip strength in kilograms, measured with a Jamar dynamometer.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Lower-limb muscle power - Five-times sit-to-stand
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
ime in seconds and estimated lower-limb power measured during the five-times sit-to-stand test using a linear encoder.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Gait speed
Time Frame: aseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Usual gait speed in meters per second.
aseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Balance
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Static balance assessed by the SPPB balance component (side-by-side, semi-tandem, and tandem stands).
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Change in Vastus Lateralis Muscle Thickness
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Change in Vastus Lateralis Echo Intensity (Muscle Quality)
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Cognition - Mini-Mental State Examination (MMSE)
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Global cognitive function measured by the MMSE, using education-adjusted cutoffs.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Change in Vivifrail functional category
Time Frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Transition across Vivifrail functional categories (Types A, B, B+, C, C+, D) over the intervention period.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 79748517.5.0000.5347
  • U1111-1343-8083 (Other Identifier: WHO Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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