Vivifrail Exercise Program in Nonagenarians: Effects on Function, Muscle, and Cognition (Vivifrail)
Effects of a Multicomponent Exercise Program Based on the Vivifrail Protocol on Functional Capacity, Muscle Morphology, and Cognition in Nonagenarians: A Randomized Clinical Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
- Hospital de Clínicas de Porto Alegre (HCPA) - Geriatrics outpatient clinic
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Porto Alegre、Rio Grande do Sul、ブラジル、90690-200
- Escola de Educação Física, Fisioterapia e Dança (ESEFID/UFRGS) - and participants' homes
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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).
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Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
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実験的：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.
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Individualized multicomponent home-based training (strength/power, balance, gait, and flexibility) prescribed according to the participant's Vivifrail functional profile.
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介入なし：Control (GC)
Participants maintain usual activities without a structured exercise program during the 24-week period.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in physical function measured by the Short Physical Performance Battery (SPPB) total score
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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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.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mobility - Timed Up and Go (TUG)
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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ime in seconds to rise, walk 3 meters, turn, return, and sit.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Mobility under dual task - Cognitive TUG and dual-task cost (DTC%) ·
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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TUG performed with a concurrent cognitive task; dual-task cost calculated as percentage change relative to single-task TUG.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Handgrip strength
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Maximal isometric handgrip strength in kilograms, measured with a Jamar dynamometer.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Lower-limb muscle power - Five-times sit-to-stand
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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ime in seconds and estimated lower-limb power measured during the five-times sit-to-stand test using a linear encoder.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Gait speed
時間枠：aseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Usual gait speed in meters per second.
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aseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Balance
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Static balance assessed by the SPPB balance component (side-by-side, semi-tandem, and tandem stands).
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)).
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Change in Vastus Lateralis Muscle Thickness
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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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.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Change in Vastus Lateralis Echo Intensity (Muscle Quality)
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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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.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Cognition - Mini-Mental State Examination (MMSE)
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Global cognitive function measured by the MMSE, using education-adjusted cutoffs.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Change in Vivifrail functional category
時間枠：Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Transition across Vivifrail functional categories (Types A, B, B+, C, C+, D) over the intervention period.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 79748517.5.0000.5347
- U1111-1343-8083 (その他の識別子：WHO Universal Trial Number (UTN))
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