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Dvojúkolové vs. vícesložkové cvičení u institucionalizovaných seniorů (DT-Fall)

2. listopadu 2026 aktualizováno: Filipe Fernandes Rodrigues, Instituto Politécnico de Leiria

Efekty dvojité úlohy versus vícesložkových cvičebních programů na strach z pádu a riziko pádu u institucionalizovaných starších dospělých: Randomizovaná kontrolovaná studie

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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

54

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

65 let a starší (Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.

Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Fear of Falling
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Functional Mobility and Fall Risk
Časové okno: 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
Časové okno: 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)
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. listopadu 2025

Primární dokončení (Aktuální)

27. února 2026

Dokončení studie (Aktuální)

27. února 2026

Termíny zápisu do studia

První předloženo

17. února 2026

První předloženo, které splnilo kritéria kontroly kvality

17. února 2026

První zveřejněno (Aktuální)

23. února 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • CE/IPLEIRIA/88/2025

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .