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

June 1, 2026 updated by: 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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ghent, Belgium, 9000
        • University Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before and 10 minutes after each experimental condition
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.
Immediately before and 10 minutes after each experimental condition
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.
Immediately before and 10 minutes after each experimental condition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Immediately after each experimental condition, during the 10-minute post-condition interval.
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.
Immediately after each experimental condition, during the 10-minute post-condition interval.
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.
Immediately after each experimental condition, during the 10-minute post-condition interval.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Greet Cardon, Prof. Dr., University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Actual)

May 13, 2026

Study Completion (Actual)

May 13, 2026

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONSCIOUS - ONZ-2025-0282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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