Vivifrail Exercise Program in Nonagenarians: Effects on Function, Muscle, and Cognition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivifrail multicomponent exercise program.
- Who it may be relevant to
- Registry conditions: Frailty, Aging, Cognitive Decline. Basic parameters: from 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (10)
- Mobility - Timed Up and Go (TUG) [Time frame: 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)).]
- Handgrip strength [Time frame: 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)).]
- Gait speed [Time frame: aseline (T0), 12 weeks (T1), and 24 weeks (T2)).]
- Balance [Time frame: 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)]
- Change in Vastus Lateralis Echo Intensity (Muscle Quality) [Time frame: 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)]
- Change in Vivifrail functional category [Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 2 centers
- Hospital de Clínicas de Porto Alegre (HCPA) - Geriatrics outpatient clinic — Porto Alegre
- Escola de Educação Física, Fisioterapia e Dança (ESEFID/UFRGS) - and participants' homes — Porto Alegre
Identifiers
NCT: NCT07731529 · 79748517.5.0000.5347 · U1111-1343-8083