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

1 september 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

54

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: Vivifrail multicomponent exercise program
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
Experimenteel: 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.
Gedragsmatig: Vivifrail multicomponent exercise program
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
Geen tussenkomst: Control (GC)
Participants maintain usual activities without a structured exercise program during the 24-week period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in physical function measured by the Short Physical Performance Battery (SPPB) total score
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mobility - Timed Up and Go (TUG)
Tijdsspanne: 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%) ·
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Federal University of Rio Grande do Sul

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 juli 2026

Primaire voltooiing (Geschat)

1 november 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 79748517.5.0000.5347
  • U1111-1343-8083 (Andere identificatie: WHO Universal Trial Number (UTN))

Plan Individuele Deelnemersgegevens (IPD)

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