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Esercizio a Doppio Compito vs. Esercizio Multicomponente per Anziani Istituzionalizzati (DT-Fall)

2 novembre 2026 aggiornato da: Filipe Fernandes Rodrigues, Instituto Politécnico de Leiria

Effetti dei Programmi di Esercizio a Doppio Compito rispetto a quelli Multicomponente sulla Paura di Cadere e sul Rischio di Caduta negli Anziani Istituzionalizzati: Uno Studio Controllato Randomizzato

The aging global population faces a major public health challenge regarding the growing number of older adults in long-term care facilities. Institutionalized older adults exhibit high rates of sedentary behavior, accelerating physiological decline (such as sarcopenia, diminished muscle strength, and impaired balance) and increasing fall risk. Beyond biomechanical risks, the fear of falling acts as a psychological barrier, creating a negative spiral of frailty where a lack of confidence leads to activity restriction. This further reduces functional capacity and paradoxically increases the actual fall risk. Addressing fall risk requires interventions targeting both the physical mechanisms of balance and the psychological mechanisms of self-efficacy.

Current WHO guidelines emphasize multicomponent physical activity (combining balance, strength, and aerobic training) to prevent falls. However, traditional programs may not fully address the cognitive-motor interference of real-world falls, which often occur during complex, divided-attention tasks. Institutionalized older adults often struggle to allocate attentional resources efficiently. This study posits that breaking the spiral of inactivity requires stimulating the complex demands of daily living. The investigators hypothesize that a Dual-Task Exercise Program, integrating cognitive challenges (e.g., executive function tasks, memory recall) into a multicomponent routine, will provide superior benefits compared to a Multicomponent Exercise Program alone. By training cognitive functions to process mental stimuli while maintaining motor control, the goal is to improve physical and cognitive capabilities and enhance participants' confidence.

This randomized controlled trial aims to compare the effects of these two modalities on physical fall risk and psychological fear of falling. Conducted in a nursing home for over 12 weeks, participants will be randomly assigned to either the Control Group (Multicomponent Training: physical strength and balance) or the Experimental Group (Dual-Task Training: physical protocol with simultaneous cognitive stimulation).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Ageing is a universal biological process. However, the trajectory of physical and cognitive decline varies significantly across individuals based on their lifestyle and environment. Literature consistently demonstrates that older adults residing in long-term care institutions (nursing homes) represent a particularly vulnerable demographic compared to those living in the community. While community-dwelling older adults often maintain a baseline level of physical activity through household chores, social interactions, and recreational tasks, institutionalized older adults frequently face an environment characterized by sedentarism and a lack of autonomy. This environmental physical deprivation in institutional settings leads not only to physical deconditioning (loss of strength, loss of balance, and reduced mobility) but also to a lack of cognitive stimulation. The absence of complex daily challenges means that these individuals rarely engage the neuro-motor pathways required to manage simultaneous tasks. Consequently, institutionalized older adults are at a disproportionately high risk of adverse health outcomes, most notably falls.

Falls are not merely biomechanical events caused by muscle weakness; they are deeply intertwined with psychological factors. Recent systematic reviews highlight fear of falling as a critical health concern that affects a vast majority of institutionalized older adults, regardless of whether they have a history of falling. Fear of falling acts as a psychological barrier that triggers a negative spiral of frailty, specifically, the fear leads to self-imposed activity restriction, which further degrades physical fitness (i.e., strength and balance), thereby paradoxically increasing the actual risk of future falls. Breaking this cycle is imperative. The literature suggests that interventions must address not only the physical capacity to move but also the confidence to move safely. While physical activity is widely recognized as a protective factor, reducing fall risk and promoting independence, the specific type of physical activity that best addresses the psychological aspect of fear of falling remains a subject of investigation.

International guidelines, such as those from the World Health Organization and Cochrane reviews, advocate for multicomponent exercise programs by combining resistance, balance, and aerobic training, as the most effective strategy for fall prevention. These programs, typically prescribed at moderate intensities, have proven effective in improving pure physical parameters like muscle strength and static balance. However, a critical gap exists between clinical improvements and real-world applicability. Standard multicomponent exercise is often performed in controlled environments where the individual focuses exclusively on the motor task (i.e., single tasking). Yet, in daily life, falls rarely occur when an individual is solely focused on walking. Instead, falls predominantly happen during complex, multi-task scenarios, such as walking while talking or carrying objects, navigating obstacles, or processing environmental cues. This discrepancy suggests that traditional multicomponent training may lack ecological validity. It strengthens the muscles but may not sufficiently train the brain to allocate attentional resources efficiently during movement, leaving the older adult vulnerable when distracted.

The Cognitive-Motor Interference theory posits that when older adults with cognitive deficits attempt to perform a motor task and a cognitive task simultaneously, performance in one or both domains deteriorates. This dual-task cost is a strong predictor of falls. Therefore, to effectively reduce fall risk and, crucially, the fear of falling, an intervention must simulate these complex demands. This leads to the hypothesis that dual-task training, the integration of simultaneous cognitive challenges (e.g., verbal fluency, arithmetic calculations, memory recall) into physical exercise, may offer superior benefits to multicomponent training alone. By forcing the central nervous system to manage competing attentional demands, dual-task training aims to improve neuroplasticity and executive function alongside physical conditioning.

The primary aim of this investigation is to determine whether increasing the complexity of the training stimulus (Dual-Task) yields greater benefits than the standard physical stimulus (Multicomponent) in institutionalized older adults. Specifically, this study seeks to understand if adding a cognitive load to a standard exercise protocol is a key ingredient required to significantly reduce fear of falling and improve functional mobility in this specific population. Rather than focusing solely on the volume or intensity of exercise, as emphasized in general guidelines, this research focuses on the specificity of the training type. If dual-task training proves more effective, it suggests that fall prevention strategies in nursing homes should move beyond simple repetitive movements and embrace physical and cognitive training. The findings will support healthcare professionals in tailoring interventions that are not only physically strengthening but also cognitively engaging, ultimately promoting a more robust and confident functional independence among the oldest old.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Leiria District
      • Alcobaça, Leiria District, Portogallo, 2460-009
        • Santa Casa da Misericórdia de Alcobaça

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Aged 65 years or older.
  • Resident in the institution (nursing home) for at least 6 months.
  • Autonomous ambulation capacity (independent walking ability, with or without walking aids like canes or walkers).
  • Medical clearance/approval to participate in physical exercise.
  • Ability to understand verbal instructions and communicate.
  • Absence of severe cognitive impairment that prevents understanding of the tasks.

Exclusion Criteria:

  • Uncontrolled cardiovascular or metabolic conditions (e.g., severe heart failure, unstable angina, recent myocardial infarction in the last month).
  • Severe musculoskeletal, visual, or auditory impairments that preclude participation in the exercise program.
  • Diagnosis of severe dementia or other neurological conditions that prevent following the protocol instructions.
  • Absence from more than 5 consecutive sessions or attendance of less than 75% of the total sessions.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Multicomponent Exercise Group

Participants in this group will perform a standard multicomponent exercise program.

The program consists of 45-60 minute sessions, twice a week for 12 weeks. It includes resistance training (using free weights, elastic bands, and body weight), static and dynamic balance training, and aerobic walking exercises. Intensity is moderate, adjusted to individual tolerance using the Borg Scale.

Sperimentale: Dual-Task Exercise Group

Participants in this group will perform the multicomponent protocol with added cognitive demands.

Participants perform the exact same physical exercises as the control group (same duration, frequency, and intensity), but with simultaneous cognitive tasks designed to induce cognitive-motor interference. Tasks include verbal fluency (naming animals/colors), arithmetic calculations (subtraction), and memory recall while performing motor movements.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Fear of Falling
Lasso di tempo: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Falls Efficacy Scale International (FES-I). This self-report questionnaire assesses the level of concern about falling during 16 social and physical activities inside and outside the home. Total scores range from 16 (no concern) to 64 (extreme concern).

Baseline (Week 0) and Post-Intervention (Week 13).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Functional Mobility and Fall Risk
Lasso di tempo: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Timed Up and Go (TUG) test. Measures the time (in seconds) required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower times indicate better mobility and reduced fall risk.

Baseline (Week 0) and Post-Intervention (Week 13).
Change in Physical Performance
Lasso di tempo: Baseline (Week 0) and Post-Intervention (Week 13).

Assessed using the Short Physical Performance Battery (SPPB). A composite score evaluating three domains: balance (side-by-side, semi-tandem, tandem stands), gait speed (4 meters), and chair stand ability (5 repetitions). Total scores range from a minimum of 0 to a maximum of 12. Higher scores indicate a better outcome (better physical function).

Baseline (Week 0) and Post-Intervention (Week 13).
Exercise Adherence (Attendance Rate)
Lasso di tempo: Through study completion (up to Week 12).

Measures the frequency of participation in the assigned exercise program. It will be recorded as the total number of sessions attended by each participant divided by the total number of scheduled sessions (24 sessions), expressed as a percentage. This variable assesses the feasibility and acceptance of the training frequency.

Through study completion (up to Week 12).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 novembre 2025

Completamento primario (Effettivo)

27 febbraio 2026

Completamento dello studio (Effettivo)

27 febbraio 2026

Date di iscrizione allo studio

Primo inviato

17 febbraio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 febbraio 2026

Primo Inserito (Effettivo)

23 febbraio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CE/IPLEIRIA/88/2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Periodo di condivisione IPD

Data will be available beginning 6 months and ending 5 years following article publication.

Criteri di accesso alla condivisione IPD

Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator (filipe.rodrigues@ipleiria.pt). To gain access, data requestors will need to sign a data access agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .