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Completed

NCT Number: NCT07630272

Optimizing Combined Physical and Cognitive Activity 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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Light physical activity + easy cognitive activity

Behavioral

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.

Light physical activity + challenging cognitive activity

Behavioral

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.

Moderate physical activity + easy cognitive activity

Behavioral

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.

Moderate physical activity + challenging cognitive activity

Behavioral

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.

Primary outcomes

  1. Change in Multitasking Test (MTT) performance from pre- to post-condition

    Time frame: 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.

  2. Change in Delayed Matching to Sample (DMS) performance from pre- to post-condition

    Time frame: 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.

  3. Change in Match to Sample Visual Search (MTS) performance from pre- to post-condition

    Time frame: 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.

Secondary outcomes

  1. General impression of each experimental condition

    Time frame: 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."

  2. Perceived feasibility of each experimental condition

    Time frame: 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.

  3. Enjoyment of each experimental condition

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Determining the Optimal Combination of Physical and Cognitive Activity for Acute Cognitive Benefits in Community-Dwelling Older Adults.

Acronym: CONSCIOUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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