NCT07731529

Brief 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. 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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Sep 2027

Study Start

First participant enrolled

July 1, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 20, 2026

Last Update Submit

July 24, 2026

Conditions

FrailtyAgingCognitive Decline

Keywords

VivifrailMulticomponent exerciseNonagenariansPhysical functionShort Physical Performance BatteryMuscle qualityMuscle morphologyHome-based exercise

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

  • Mobility - Timed Up and Go (TUG)

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

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

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

  • Handgrip strength

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

  • Lower-limb muscle power - Five-times sit-to-stand

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

  • Gait speed

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

  • +5 more secondary outcomes

Study Arms (3)

Vivifrail - 2 sessions/week (G1)

EXPERIMENTAL

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

Vivifrail - 3 sessions/week (G2)

EXPERIMENTAL

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

Control (GC)

NO INTERVENTION

Participants maintain usual activities without a structured exercise program during the 24-week period.

Interventions

Vivifrail multicomponent exercise programBEHAVIORAL

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

Vivifrail - 2 sessions/week (G1)Vivifrail - 3 sessions/week (G2)

Eligibility Criteria

Age90 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

MeSH Terms

Conditions

FrailtyCognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

ALESSANDRA Silva QUADROS

CONTACT

+5551991020557quadros.ale@gmail.com

Caroline Pietta Dias, PhD

CONTACT

+55 51 84484400carolpieta@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded to group allocation. Participants and interventionists cannot be blinded due to the autonomous, home-based nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate and Principal Investigator

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 28, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations

BR(2)