- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07714148
Visual Stimulus-Based Cognitive-Motor Agility Exercise in Older Adults
Effects of Visual Stimulus-Based Cognitive-Motor Agility Exercise on Cognitive, Psychomotor, and Functional Performance in Older Adults: A Randomized Controlled Trial
Přehled studie
Postavení
Detailní popis
This study was designed as an 8-week, parallel-group randomized controlled exercise intervention in community-dwelling older adults. The study aimed to determine whether adding a brief Light Trainer-assisted visual stimulus-based cognitive-motor agility exercise component to a multicomponent exercise program would provide additional benefits for cognitive, psychomotor, and functional performance.
After completion of baseline assessments, eligible participants were randomized to either an experimental group or an active control group. Both groups participated in supervised exercise sessions twice weekly for 8 weeks, for a total of 16 sessions. Each session lasted 45 minutes. The first 35 minutes of each session consisted of the same multicomponent exercise program in both groups. This program included light-paced walking, mobility exercises, multidirectional stepping, balance tasks, agility exercise, coordination exercises, low-resistance strengthening exercises, and functional movement combinations.
During the final 10 minutes of each session, participants in the experimental group completed visual stimulus-based cognitive-motor agility exercises using the Light Trainer system. These tasks required participants to perceive randomized visual stimuli, select an appropriate motor response, and respond as quickly and accurately as possible using hand or foot movements. The Light Trainer component included 13 repetitions of 30-second task intervals separated by 15-second rest periods. Task difficulty progressed across the 8-week intervention by increasing the number of modules from two to six and by increasing task complexity, stimulus randomness, movement direction changes, response speed requirements, and cognitive-motor demands.
Participants in the active control group completed the same 35-minute multicomponent exercise program followed by a time-matched 10-minute low-intensity activity period. These activities included supervised stretching, mobility, agility, balance, or recovery exercises and did not include visual stimulus-based response tasks, rapid decision-making, reactive agility tasks, or Light Trainer-assisted exercises.
Assessments were performed at baseline and after the 8-week intervention period. The primary outcome was global cognitive performance assessed using the Montreal Cognitive Assessment. Secondary outcomes included hand and foot visual-motor response time, visual working memory performance time and accuracy, Ten-Step Test, 30-second Chair Stand Test, 30-second Arm Curl Test, and 8-Foot Up-and-Go Test. The study was conducted in community-dwelling older adults aged 60 years or older who were able to ambulate independently and follow basic exercise and testing instructions.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Çanakkale, Turecko (Türkiye), 17100
- Canakkale Onsekiz Mart University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Community-dwelling older adults aged 60 years or older
- Able to ambulate independently
- Able to understand and follow basic exercise and testing instructions
- Montreal Cognitive Assessment score of 23 or higher
- No health condition that would limit safe participation in exercise
- Able to participate regularly in the 8-week exercise program
Exclusion Criteria:
- Serious cardiovascular, neurological, orthopedic, or vestibular disease that could prevent safe participation in exercise
- Recent surgery
- Uncontrolled hypertension
- Severe visual or hearing problems
- Montreal Cognitive Assessment score below 23
- Use of medications known to substantially affect cognitive, psychomotor, balance, or motor performance
- Very low physical function preventing safe participation in the exercise program
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Visual stimuli Cognitive-Motor Agility Exercise
Participants in this arm completed supervised exercise sessions twice weekly for 8 weeks.
Each 45-minute session included the same 35-minute multicomponent exercise program performed by both groups, followed by 10 minutes of Light Trainer-assisted visual stimulus-based cognitive-motor agility exercise.
The Light Trainer component included reactive visual-motor tasks requiring participants to respond to randomized visual stimuli using hand and foot movements.
|
Participants completed a supervised 35-minute multicomponent exercise program twice weekly for 8 weeks.
The program included light-paced walking, mobility exercises, multidirectional stepping, balance tasks, coordination exercises, low-resistance strengthening exercises, and functional movement combinations.
This component was performed by both the experimental and active control groups.
The experimental group completed a 10-minute Light Trainer-assisted visual stimulus-based cognitive-motor agility exercise component during the final part of each supervised session.
Tasks required participants to perceive randomized visual stimuli, select an appropriate motor response, and respond as quickly and accurately as possible using hand or foot movements.
Each session included 13 repetitions of 30-second task intervals separated by 15-second rest periods.
Task difficulty progressed across 8 weeks by increasing the number of modules from two to six and increasing task complexity.
|
|
Aktivní komparátor: Active Control: Multicomponent Exercise With Low-Intensity Activities
Participants in this arm completed supervised exercise sessions twice weekly for 8 weeks.
Each 45-minute session included the same 35-minute multicomponent exercise program performed by the experimental group, followed by 10 minutes of time-matched low-intensity activities.
These activities included supervised stretching, mobility, balance, or recovery exercises and did not include visual stimulus-based response tasks, rapid decision-making, reactive agility tasks, or Light Trainer-assisted exercises.
|
Participants completed a supervised 35-minute multicomponent exercise program twice weekly for 8 weeks.
The program included light-paced walking, mobility exercises, multidirectional stepping, balance tasks, coordination exercises, low-resistance strengthening exercises, and functional movement combinations.
This component was performed by both the experimental and active control groups.
The active control group completed a 10-minute time-matched low-intensity activity period during the final part of each supervised session.
These activities included stretching, mobility, balance, or recovery exercises and did not include visual stimulus-based response tasks, rapid decision-making, reactive agility tasks, or Light Trainer-assisted exercises.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Montreal Cognitive Assessment Score
Časové okno: Baseline and 8 weeks
|
The Montreal Cognitive Assessment was used to assess global cognitive function.
Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Change from baseline to 8 weeks was evaluated.
The Montreal Cognitive Assessment was used to assess global cognitive function.
Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Change from baseline to 8 weeks was evaluated.
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Baseline and 8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Ten-Step Test Time
Časové okno: Baseline and after 8 weeks
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Lower-extremity rapid stepping and agility performance were assessed using the Ten-Step Test.
Participants completed 10 alternating stepping movements on a 10-cm step block as quickly as possible.
Test duration was recorded in seconds.
Shorter time indicates better performance.
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Baseline and after 8 weeks
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Change in Hand Visual-Motor Response Time
Časové okno: Baseline and 8 weeks
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Hand visual-motor response performance was assessed using the Light Trainer system.
Participants responded to randomized visual stimuli by touching illuminated modules with either hand during a 30-second task.
Fastest and mean response times were recorded in seconds.
Shorter response times indicate better performance.
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Baseline and 8 weeks
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Change in Foot Visual-Motor Response Time
Časové okno: Baseline and 8 weeks
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Foot visual-motor response performance was assessed using the Light Trainer system.
Participants responded to randomized visual stimuli by stepping on illuminated modules with either foot during a 30-second task.
Fastest and mean response times were recorded in seconds.
Shorter response times indicate better performance.
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Baseline and 8 weeks
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Change in Visual Working Memory Performance Time
Časové okno: Baseline and 8 weeks
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Visual working memory response time was assessed using the memory mode of the Light Trainer system.
Participants memorized the color and position of illuminated modules and then identified the module corresponding to a target color.
Fastest times were recorded in seconds, with shorter values indicating better visual working memory performance.
Change from baseline to 8 weeks was evaluated.
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Baseline and 8 weeks
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Change in Visual Working Memory Accuracy
Časové okno: Baseline and 8 weeks
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Visual working memory accuracy was assessed using the memory mode of the Light Trainer system.
Participants memorized the color and position of illuminated modules and then identified the module corresponding to a target color.
Accuracy was expressed as the device-recorded percentage of correct responses across all trials and ranged from 0% to 100%, with higher values indicating better visual working memory performance.
Change from baseline to 8 weeks was evaluated.
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Baseline and 8 weeks
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Change in 30-Second Chair Stand Test Performance
Časové okno: Baseline and 8 weeks
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Lower-body functional strength was assessed using the 30-second Chair Stand Test.
Participants were instructed to stand up fully and sit down as many times as possible within 30 seconds.
The total number of correctly completed repetitions was recorded.
Higher repetition count indicates better performance.
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Baseline and 8 weeks
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Change in 30-Second Arm Curl Test Performance
Časové okno: Baseline and 8 weeks
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Upper-body functional strength was assessed using the 30-second Arm Curl Test.
Participants performed as many controlled elbow flexion-extension repetitions as possible within 30 seconds while seated.
The test was performed separately for the right and left arms.
Higher repetition count indicates better performance.
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Baseline and 8 weeks
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Change in 8-Foot Up-and-Go Test Time
Časové okno: Baseline and 8 weeks
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Functional mobility, agility, and dynamic balance were assessed using the 8-Foot Up-and-Go Test.
Participants rose from a chair, walked around a marker placed 2.44 meters away, returned to the chair, and sat down again.
Test duration was recorded in seconds.
Shorter time indicates better performance.
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Baseline and 8 weeks
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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