Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Optimizing Combined Physical and Cognitive Activity in Community-Dwelling Older Adults. (CONSCIOUS)

1 juni 2026 bijgewerkt door: University Ghent

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

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

53

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Ghent, België, 9000
        • University Ghent

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.
Experimenteel: 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.
Experimenteel: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Multitasking Test (MTT) performance from pre- to post-condition
Tijdsspanne: Immediately before and 10 minutes after each experimental condition
Change in accuracy and response latency from pre- to post-condition on the Multitasking Test (MTT), assessing executive functioning, cognitive flexibility, and processing speed.
Immediately before and 10 minutes after each experimental condition
Change in Delayed Matching to Sample (DMS) performance from pre- to post-condition
Tijdsspanne: Immediately before and 10 minutes after each experimental condition
Change in accuracy and response latency from pre- to post-condition on the Delayed Matching to Sample (DMS), assessing short-term visual recognition memory.
Immediately before and 10 minutes after each experimental condition
Change in Match to Sample Visual Search (MTS) performance from pre- to post-condition
Tijdsspanne: Immediately before and 10 minutes after each experimental condition
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.
Immediately before and 10 minutes after each experimental condition

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
General impression of each experimental condition
Tijdsspanne: Immediately after each experimental condition, during the 10-minute post-condition interval.
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."
Immediately after each experimental condition, during the 10-minute post-condition interval.
Perceived feasibility of each experimental condition
Tijdsspanne: Immediately after each experimental condition, during the 10-minute post-condition interval.
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.
Immediately after each experimental condition, during the 10-minute post-condition interval.
Enjoyment of each experimental condition
Tijdsspanne: Immediately after each experimental condition, during the 10-minute post-condition interval.
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.
Immediately after each experimental condition, during the 10-minute post-condition interval.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Greet Cardon, Prof. Dr., University Ghent

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 februari 2026

Primaire voltooiing (Werkelijk)

13 mei 2026

Studie voltooiing (Werkelijk)

13 mei 2026

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CONSCIOUS - ONZ-2025-0282

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data collected during the study will be made available to other researchers. The exact dataset(s), supporting documents, timing, and access procedures will be specified after completion of the main analyses and publication of the primary study results.

IPD-tijdsbestek voor delen

De-identified individual participant data will become available after publication of the primary study results and are expected to remain available indefinitely in an institutional or open research repository.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren