An interventional study of Vivifrail multicomponent exercise program in Frailty, Aging and Cognitive Decline, sponsored by Federal University of Rio Grande do Sul. Enrolling by invitation at 2 sites in Brazil. Open to participants aged 90 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment
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).
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 54 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants maintain usual activities without a structured exercise program during the 24-week period.
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
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.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Mobility - Timed Up and Go (TUG)
ime in seconds to rise, walk 3 meters, turn, return, and sit.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Handgrip strength
Maximal isometric handgrip strength in kilograms, measured with a Jamar dynamometer.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Gait speed
Usual gait speed in meters per second.
Time frame: aseline (T0), 12 weeks (T1), and 24 weeks (T2)).
Balance
Static balance assessed by the SPPB balance component (side-by-side, semi-tandem, and tandem stands).
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Cognition - Mini-Mental State Examination (MMSE)
Global cognitive function measured by the MMSE, using education-adjusted cutoffs.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Change in Vivifrail functional category
Transition across Vivifrail functional categories (Types A, B, B+, C, C+, D) over the intervention period.
Time frame: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2027, 16 months after the start.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 16 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Federal University of Rio Grande do Sul →