- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07630272
Optimizing Combined Physical and Cognitive Activity in Community-Dwelling Older Adults. (CONSCIOUS)
Determining the Optimal Combination of Physical and Cognitive Activity for Acute Cognitive Benefits in Community-Dwelling Older Adults.
This laboratory-based interventional study aims to determine which combination of physical activity intensity and cognitive activity difficulty yields the greatest acute cognitive benefits in community-dwelling older adults.
The main question it aims to answer is:
- Which combination of physical and cognitive activity results in the greatest short-term improvement in cognitive functioning?
Researchers will compare four different combinations of physical intensity and cognitive task difficulty to determine whether one combination stands out. In addition, the study examines whether these effects differ depending on baseline cardiorespiratory fitness.
Participants will:
- undergo a preparatory phase in which their cardiorespiratory fitness, individualized physical activity intensity levels, and cognitive activity difficulty levels are established
- visit the laboratory four times, with one week between visits, to complete each combination of physical and cognitive activity (light vs. moderate physical activity × easy vs. challenging cognitive activity)
- complete cognitive tests immediately before and after each condition
Przegląd badań
Status
Warunki
Szczegółowy opis
Recognizing the escalating dementia rates, its profound social and economic consequences and the lack of curative treatments, the World Health Organization (WHO) emphasizes the importance of reducing modifiable risk factors for dementia, as outlined in Action Area 3 of the WHO Global action plan on the public health response to dementia 2017-2025. Previous research suggests that combining physical activity and cognitive activity may produce greater cognitive benefits than either activity alone, but it remains unclear which specific combinations are most effective in older adults. In particular, little is known about how physical activity intensity and cognitive activity difficulty interact, and whether cardiorespiratory fitness influences these effects. The present study addresses this knowledge gap in community-dwelling older adults.
The study is conducted in two consecutive parts. In the preparatory phase, participants attend one laboratory visit. During this phase, baseline screening and descriptive assessments will be performed, cardiorespiratory fitness will beestimated using the 6-Minute Walk Test, individualized physical activity intensity zones will be determined using heart-rate reserve, and cognitive activities will be classified as easy or challenging based on subjective ratings. Participants will also be familiarized with treadmill walking and simultaneous physical and cognitive task performance.
In the fundamental phase, eligible participants will complete four laboratory sessions in randomized order, each involving one combination of physical and cognitive activity: light physical activity with easy cognitive activity, light physical activity with challenging cognitive activity, moderate physical activity with easy cognitive activity, and moderate physical activity with challenging cognitive activity. During each session, participants walk on a treadmill at a prescribed heart-rate-based intensity while simultaneously performing cognitive tasks. Cognitive functioning is assessed immediately before and after each session using three tasks from the CANTAB neuropsychological test battery: a) Multitasking test (MTT), (b) Delayed Matching to Sample (DMS), and (c) Match to Sample Visual Search (MTS), allowing the study to examine the short-term cognitive effects of each physical activity × cognitive activity combination. The overall aim is to identify the optimal combination of simultaneous physical and cognitive activity for acute cognitive benefits in older adults.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ghent, Belgia, 9000
- University Ghent
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Aged 65 years or older
- Community-dwelling
- Able to safely walk on a treadmill and complete the 6-Minute Walk Test
- Sufficient Dutch proficiency to understand study instructions and complete study procedures
Exclusion Criteria:
- MoCA score < 23
- Severe cognitive or physical impairment that would hinder participation or understanding of study procedures
- Use of medication affecting heart rate
- Any medical condition contraindicating engagement in physical or cognitive activity
- Severe visual or hearing impairment that would prevent valid participation in the study procedures
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Sequence 1
Participants complete the four experimental conditions in the following order across four separate laboratory visits: C1, C2, C3, and C4.
C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity.
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Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
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Eksperymentalny: Sequence 2
Participants complete the four experimental conditions in the following order across four separate laboratory visits: C2, C4, C1, and C3. C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity. |
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
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Eksperymentalny: Sequence 3
Participants complete the four experimental conditions in the following order across four separate laboratory visits: C3, C1, C4, and C2. C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity. |
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
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|
Eksperymentalny: Sequence 4
Participants complete the four experimental conditions in the following order across four separate laboratory visits: C4, C3, C2, and C1. C1 = light physical activity + easy cognitive activity; C2 = light physical activity + challenging cognitive activity; C3 = moderate physical activity + easy cognitive activity; C4 = moderate physical activity + challenging cognitive activity. |
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized light physical activity intensity (30-39% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as easy.
Participants walk on a treadmill at an individualized moderate physical activity intensity (40-59% of heart rate reserve) while performing cognitive tasks individually classified as challenging.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Multitasking Test (MTT) performance from pre- to post-condition
Ramy czasowe: Immediately before and 10 minutes after each experimental condition
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Change in accuracy and response latency from pre- to post-condition on the Multitasking Test (MTT), assessing executive functioning, cognitive flexibility, and processing speed.
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Immediately before and 10 minutes after each experimental condition
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Change in Delayed Matching to Sample (DMS) performance from pre- to post-condition
Ramy czasowe: Immediately before and 10 minutes after each experimental condition
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Change in accuracy and response latency from pre- to post-condition on the Delayed Matching to Sample (DMS), assessing short-term visual recognition memory.
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Immediately before and 10 minutes after each experimental condition
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Change in Match to Sample Visual Search (MTS) performance from pre- to post-condition
Ramy czasowe: Immediately before and 10 minutes after each experimental condition
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Change in accuracy and response latency from pre- to post-condition on the Match to Sample Visual Search (MTS), assessing visual attention and psychomotor speed.
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Immediately before and 10 minutes after each experimental condition
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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General impression of each experimental condition
Ramy czasowe: Immediately after each experimental condition, during the 10-minute post-condition interval.
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Self-reported general impression of each experimental condition, rated on a 0-10 scale, where 0 indicates "not good at all" and 10 indicates "very good."
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Immediately after each experimental condition, during the 10-minute post-condition interval.
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Perceived feasibility of each experimental condition
Ramy czasowe: Immediately after each experimental condition, during the 10-minute post-condition interval.
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Self-reported feasibility of each experimental condition, rated on a 0-10 scale in response to the statement "I feel capable of doing this session," where higher scores indicate greater perceived feasibility.
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Immediately after each experimental condition, during the 10-minute post-condition interval.
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Enjoyment of each experimental condition
Ramy czasowe: Immediately after each experimental condition, during the 10-minute post-condition interval.
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Self-reported enjoyment of each experimental condition, rated on a 0-10 scale in response to the statement "I enjoyed this session," where higher scores indicate greater enjoyment.
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Immediately after each experimental condition, during the 10-minute post-condition interval.
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Greet Cardon, Prof. Dr., University Ghent
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
- CONSCIOUS - ONZ-2025-0282
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
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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