Aging, Cognitive Decline, Frailty
Conditions
Keywords
Vivifrail, Multicomponent exercise, Nonagenarians, Physical function, Short Physical Performance Battery, Muscle quality, Muscle morphology, Home-based exercise
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).
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
Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to group allocation. Participants and interventionists cannot be blinded due to the autonomous, home-based nature of the intervention.
Eligibility
Sex/Gender
ALL
Age
90 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical function measured by the Short Physical Performance Battery (SPPB) total score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility - Timed Up and Go (TUG) | Baseline (T0), 12 weeks (T1), and 24 weeks (T2) | ime in seconds to rise, walk 3 meters, turn, return, and sit. |
| Mobility under dual task - Cognitive TUG and dual-task cost (DTC%) · | 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. |
| Handgrip strength | Baseline (T0), 12 weeks (T1), and 24 weeks (T2)). | Maximal isometric handgrip strength in kilograms, measured with a Jamar dynamometer. |
| Lower-limb muscle power - Five-times sit-to-stand | 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. |
| Gait speed | aseline (T0), 12 weeks (T1), and 24 weeks (T2)). | Usual gait speed in meters per second. |
| Balance | 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). |
| Change in Vastus Lateralis Muscle Thickness | 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. |
| Change in Vastus Lateralis Echo Intensity (Muscle Quality) | 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. |
| Cognition - Mini-Mental State Examination (MMSE) | Baseline (T0), 12 weeks (T1), and 24 weeks (T2) | Global cognitive function measured by the MMSE, using education-adjusted cutoffs. |
| Change in Vivifrail functional category | 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. |
Countries
Brazil
Outcome results
None listed