- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07823166
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait
Comparison of the Effects of Motor and Cognitive Dual Task Exercises on Fall Risk, Balance, and Gait in Geriatric Individuals Residing in Nursing Homes: A Randomized Controlled Trial
This study aimed to compare the effects of motor and cognitive dual-task exercise programs on fall risk, balance, and gait performance in older adults residing in nursing homes.The main question it aims to answer is:
An eight-week motor or cognitive dual-task exercise program did not provide additional benefits over standard single-task exercise in improving fall risk, balance, or gait performance in nursing home residents.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Assessments were conducted before and after the intervention using the Five-Repetition Sit-to-Stand Test, 2-Minute Walk Test, Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Scale, and Functional Reach Test.
Przegląd badań
Status
Szczegółowy opis
Individuals residing in nursing homes who were aged between 65 and 95 years, able to walk independently, literate, willing to participate, and cognitively capable of understanding and performing the assessments and exercises were included in the study.
Individuals with systemic or metabolic conditions such as malignancy, osteoporosis, history of fracture, coagulation disorders, active infection, orthostatic hypotension, or pacemaker implantation were excluded. Participants were withdrawn from the study if they discontinued the intervention, failed to attend pre- or post-intervention assessments, or were unable to understand or perform the required tests and exercises.
A total of 69 eligible participants were allocated into three groups using a systematic allocation sequence based on the order of enrollment. Participants were assigned sequentially to the motor dual-task group, cognitive dual-task group, or control group in a 1:1:1 ratio.
Due to the absence of a dedicated exercise room, all interventions were conducted in participants' rooms using space-adapted exercise protocols.
Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task. During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
Baseline demographic characteristics, including participant identification number, group allocation, age, sex, body weight, and height, were recorded using a standardized assessment form. All evaluations were performed before and after the eight-week intervention period by the same physiotherapist to ensure assessment consistency and minimize inter-rater variability.
Fall risk was assessed using the Five Times Sit-to-Stand Test (FTSST). Balance and gait performance were evaluated using the 2-Minute Walk Test (2MWT), Single-Leg Stance Test, Timed Up and Go (TUG) Test, Tinetti Balance and Gait Assessment Scale, and Functional Reach Test.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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ÇANKAYA
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Ankara, ÇANKAYA, Turcja (Türkiye), 06550
- Altınçatı Nursing Home and Elderly Care Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- residing in nursing homes who were aged between 65 and 95 years
- Individuals able to walk independently
- Individuals who are literate
- Individuals willing to participate in the study
- Individuals cognitively capable of understanding and performing the required assessments and exercises.
Exclusion Criteria:
- Individuals with malignancy
- Individuals with osteoporosis
- Individuals with a history of fracture
- Individuals with coagulation disorders
- Individuals with an active infection
- Individuals with orthostatic hypotension
- Individuals with pacemaker implantation
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Grupa kontrolna
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The control group performed a conventional exercise program of equivalent duration and frequency without any additional dual-task component.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
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Eksperymentalny: Motor Dual-Task Exercise Group
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Participants in the motor dual-task group performed a structured exercise program consisting of the Five Times Sit-to-Stand Test, Timed Up and Go test (3 m), single-leg stance, 10-meter tandem walking, 10-meter normal walking, and a 20-meter marching activity while simultaneously carrying a tray filled with water.
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
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Eksperymentalny: Cognitive Dual-Task Exercise Group
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Participants in the cognitive dual-task group performed the same exercise program combined with a concurrent cognitive task.
During each exercise, participants were instructed to verbally generate proper nouns beginning with the letter "A".
All interventions were administered for approximately 40 minutes per session, three times per week, for eight weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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2-Minute Walk Test (2MWT)
Ramy czasowe: 8 weeks
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Walking capacity was assessed over a 30-meter walkway during a two-minute period.
Participants wore comfortable clothing and footwear and rested for 10 minutes before testing.
The total walking distance was recorded in meters.
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8 weeks
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Five Times Sit-to-Stand Test (FTSST)
Ramy czasowe: 8 weeks
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The FTSST was used to assess lower extremity strength, functional mobility, and fall risk.
Participants were instructed to stand up from a standard chair and sit down five consecutive times as quickly as possible while keeping their arms crossed over the chest.
Total completion time was recorded using a stopwatch.
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8 weeks
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Timed Up and Go (TUG) Test
Ramy czasowe: 8 weeks
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Functional mobility was assessed by measuring the time required for participants to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down.
Time was recorded in seconds using a stopwatch.
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8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Single-Leg Stance Test
Ramy czasowe: 8 weeks
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Static balance was evaluated by asking participants to stand on one leg while lifting the opposite foot approximately 5 cm off the ground.
Participants were instructed to maintain balance for as long as possible, and the duration was recorded using a stopwatch.
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8 weeks
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Tinetti Balance and Gait Assessment Scale
Ramy czasowe: 8 weeks
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Balance and gait performance were assessed using the Tinetti Balance and Gait Assessment Scale according to standardized administration procedures.
Total scores were used to classify fall risk.
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8 weeks
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Functional Reach Test
Ramy czasowe: 8 weeks
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Dynamic balance was assessed using the Functional Reach Test.
A measuring tape was positioned horizontally on the wall at shoulder height.
Participants were instructed to reach forward as far as possible with the dominant arm elevated to 90° shoulder flexion without stepping or losing balance.
The distance between the initial and maximal reach positions was recorded in centimeters.
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8 weeks
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Współpracownicy i badacze
Śledczy
- Główny śledczy: BİHTER AKINOĞLU, Assoc. Prof. Dr., PT., Ankara Yildirim Beyazıt University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AYBU-FTR-BA-11
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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