HealthyCONSCIOUSNCT07630272
Optimizing Combined Physical and Cognitive Activity in Community-Dwelling Older Adults.
A study testing Light physical activity + easy cognitive activity, Light physical activity + challenging cognitive activity and Moderate physical activity + easy cognitive activity in people with Healthy, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- Light physical activity + easy cognitive activity, Light physical activity + challenging cognitive activity and Moderate physical activity + easy cognitive activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Feb 2026to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Healthy
- Being tested
- Light physical activity + easy cognitive activity, Light physical activity + challenging cognitive activity, Moderate physical activity + easy cognitive activity, Moderate physical activity + challenging cognitive activity
- Keywords
- community-dwelling older adults, physical activity, cognitive activity, healthy ageing
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light physical activity + easy cognitive activityBehavioural
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 activityBehavioural
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 activityBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 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. Receives: Behavioral: Light physical activity + easy cognitive activity; Behavioral: Light physical activity + challenging cognitive activity; Behavioral: Moderate physical activity + easy cognitive activity; Behavioral: Moderate physical activity + challenging cognitive activity |
| Sequence 2 | Experimental | 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. Receives: Behavioral: Light physical activity + easy cognitive activity; Behavioral: Light physical activity + challenging cognitive activity; Behavioral: Moderate physical activity + easy cognitive activity; Behavioral: Moderate physical activity + challenging cognitive activity |
| Sequence 3 | Experimental | 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. Receives: Behavioral: Light physical activity + easy cognitive activity; Behavioral: Light physical activity + challenging cognitive activity; Behavioral: Moderate physical activity + easy cognitive activity; Behavioral: Moderate physical activity + challenging cognitive activity |
| Sequence 4 | Experimental | 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. Receives: Behavioral: Light physical activity + easy cognitive activity; Behavioral: Light physical activity + challenging cognitive activity; Behavioral: Moderate physical activity + easy cognitive activity; Behavioral: Moderate physical activity + challenging cognitive activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Multitasking Test (MTT) performance from pre- to post-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.
Measured: Immediately before and 10 minutes after each experimental condition
Change in Delayed Matching to Sample (DMS) performance from pre- to post-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.
Measured: Immediately before and 10 minutes after each experimental condition
Change in Match to Sample Visual Search (MTS) performance from pre- to post-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.
Measured: Immediately before and 10 minutes after each experimental condition
Secondary outcomes (3)
General impression of each experimental condition
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."
Measured: Immediately after each experimental condition, during the 10-minute post-condition interval.
Perceived feasibility of each experimental condition
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.
Measured: Immediately after each experimental condition, during the 10-minute post-condition interval.
Enjoyment of each experimental condition
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.
Measured: Immediately after each experimental condition, during the 10-minute post-condition interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start2 Feb 2026
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greet Cardon, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630272
- Sponsor's protocol ID
- CONSCIOUS - ONZ-2025-0282
- Acronym
- CONSCIOUS
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Optimal Combination of Physical and Cognitive Activity for Acute Cognitive Benefits in Community-Dwelling Older Adults.
- ClinicalTrials.gov ID
- NCT07630272
- Acronym / sponsor ID
- CONSCIOUS / CONSCIOUS - ONZ-2025-0282
- Conditions
- Healthy
- Keywords
- community-dwelling older adults, physical activity, cognitive activity, healthy ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Behavioral: Light physical activity + easy cognitive activity, Behavioral: Light physical activity + challenging cognitive activity, Behavioral: Moderate physical activity + easy cognitive activity, Behavioral: Moderate physical activity + challenging cognitive activityParticipants 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. |
| Sequence 2 | Experimental | Behavioral: Light physical activity + easy cognitive activity, Behavioral: Light physical activity + challenging cognitive activity, Behavioral: Moderate physical activity + easy cognitive activity, Behavioral: Moderate physical activity + challenging cognitive activityParticipants 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. |
| Sequence 3 | Experimental | Behavioral: Light physical activity + easy cognitive activity, Behavioral: Light physical activity + challenging cognitive activity, Behavioral: Moderate physical activity + easy cognitive activity, Behavioral: Moderate physical activity + challenging cognitive activityParticipants 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. |
| Sequence 4 | Experimental | Behavioral: Light physical activity + easy cognitive activity, Behavioral: Light physical activity + challenging cognitive activity, Behavioral: Moderate physical activity + easy cognitive activity, Behavioral: Moderate physical activity + challenging cognitive activityParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light physical activity + easy cognitive activityParticipants 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. | Behavioural | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Light physical activity + challenging cognitive activityParticipants 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. | Behavioural | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Moderate physical activity + easy cognitive activityParticipants 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. | Behavioural | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Moderate physical activity + challenging cognitive activityParticipants 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. | Behavioural | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
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.
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.
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.
3 secondary outcomes
General impression of each experimental condition
Time frame: 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.
Enjoyment of each experimental condition
Time frame: Immediately after each experimental condition, during the 10-minute post-condition interval.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greet Cardon, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light physical activity + easy cognitive activity, Light physical activity + challenging cognitive activity and Moderate physical activity + easy cognitive activity in people with Healthy, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Multitasking Test (MTT) performance from pre- to post-condition (time frame: Immediately before and 10 minutes after each experimental condition). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.