Cognitive PerformanceNCT05226039
The Effects of a Single Bout of Aerobic Exercise on Cognition: The Moderating Role of Age
A study testing Moderate intensity acute exercise bout in people with Cognitive Performance, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
The current clinical study will have two groups of participants (young adults ages 20 - 30, and older adults ages 60 - 70) take part in three visits to the lab. On the first visit participants will fill out questionnaires assessing demographics and physical activity level. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Moderate intensity acute exercise bout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 20 May 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 30 years old for young adult group
- 60 to 70 years old for older adult group
- Cognitive normal (assessed via Montreal Cognitive Assessment on visit 1)
Who cannot join
- Do not have any contraindications to exercise (assessed via American College of Sport Medicine Health screening form)
- No current musculoskeletal injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Greensboro
Greensboro, North Carolina, 27402
About this study
The current clinical study will have two groups of participants (young adults ages 20 - 30, and older adults ages 60 - 70) take part in three visits to the lab. On the first visit participants will fill out questionnaires assessing demographics and physical activity level. On the 2nd and 3rd visits participants will be engage in both a moderate intensity bout of aerobic exercise for 20 minutes, and 20 minutes of resting on a stationary bike watching an educational video. These two visits will be counterbalanced across age groups. Following both the exercise bout and the resting control condition participants will complete cognitive tasks assessing episodic memory and executive functioning. The first hypothesis is that older adults who are more physically active (assessed via questionnaire) will have significantly greater cognitive abilities compared to those who are less active or sedentary. The second hypothesis is that following a single bout of moderate intensity aerobic exercise, older adults will have a greater magnitude of change in their short-term memory, and long-term memory performance compared to younger adults.
Read the detailed description
Participants who express interest in the study will be contacted by telephone. During this phone call, the primary investigator will assess the inclusion/exclusion criteria (i.e., investigators will ask their age, if participants are willing to stay inactive during the required times, refrain from caffeine and food intake within an hour of every visit). Eligible participants will be scheduled for their 1st visit. On the first day of participation in the study, participants will read and sign the informed consent, complete questionnaires, and (to further assess their eligibility for both parts of the study) participants will perform the Montreal Cognitive Assessment, fill out a physical activity questionnaire, and complete a health history form (American College of Sports Medicine). On visit 1 participants will also complete cognitive tasks measuring memory and executive functioning. Investigators will assess resting heart rate by having participants put on a heart rate monitor to record R-R intervals (to assess heart rate variability) at rest for 5 minutes. If participants meet the eligibility requirements assessed on visit 1 (> 90 mins of physical activity/week) participants will qualify and be scheduled for visits 2 and 3.
During visits 2 and 3, participants will put on a heart rate monitor so that investigators can record their heart rate during the two conditions. Participants will then perform one of two conditions in a counterbalanced order. Participants will either rest for 25 minutes while watching an educational video, do the memory task, complete tasks measuring executive functioning (Stroop color word task, spatial working memory task), and do the recall task; or exercise for 25 min, do the memory task, complete the executive functioning tasks and do the recall task. The memory task is the Auditory Verbal Learning Test (AVLT) which consists of hearing and recalling a list of 15 words (List A) 5 times, hearing and recalling a different list of 15 words (List B), and then recalling List A. Participants will be audio recorded during the memory task to ensure that accurate scoring can be completed. The executive functioning tasks (Stroop, Spatial working memory task) will involve participants responding to stimuli on a computer via a keyboard. The Stroop task requires participants to respond to the color of stimuli that come up on the screen and the Spatial working memory task requires participants to remember the position of varying numbers of dots. The recall task involves participants recalling List A and then being asked to identify from a list of words those that came from List A or List B (recognition). The exercise consists of 5-min of warm-up followed by 20 min of moderate intensity exercise (55-65% heart rate reserve at 60-80 revolutions per minute). All exercise and rest periods will be on a cycle ergometer. During all memory tasks, there will be audio-taping. Subjects will be scheduled with a minimum of 48 hours between Day 1 and Day 2 and between Day 2 and Day 3.
- Conditions
- Cognitive Performance
- Being tested
- Moderate intensity acute exercise bout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity acute exercise boutBehavioural
The treatment/intervention will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. Intensity will be prescribed based off of heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| Young adult group | Other | One group will consist of 20 to 30 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. Receives: Behavioral: Moderate intensity acute exercise bout |
| Older adult group | Other | The other group will consist of 60 to 70 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. Receives: Behavioral: Moderate intensity acute exercise bout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory - Rey Auditory Verbal Learning Task Visit 1
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Measured: Approximately 20 minutes into visit 1.
Episodic memory - Rey Auditory Verbal Learning Task Visit 2
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Measured: immediately following exercise or control (witnin 5 minutes)
Episodic memory - Rey Auditory Verbal Learning Task Visit 3
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Measured: immediately following exercise or control (within 5 minutes)
Episodic memory - Associative memory task Visit 1
Participants will hear pairs of words read to them over an audio recording. Following this they will be asked to name the second word in each pair during recall. The number of words correctly recalled on 3 trials will be measured.
Measured: Approximately 45 minutes into visiti 1.
Secondary outcomes (12)
Executive functioning - Stroop reaction time Visit 1
Executive functioning will be assessed using a Stroop Color Word task. Reaction time will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop reaction time Visit 2
Executive functioning will be assessed using a Stroop Color Word task. Reaction time will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop reaction time Visit 3
Executive functioning will be assessed using a Stroop Color Word task. Reaction time will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 1
Executive functioning will be assessed using a Stroop Color Word task. Accuracy on the task will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 2
Executive functioning will be assessed using a Stroop Color Word task. Accuracy on the task will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 3
Executive functioning will be assessed using a Stroop Color Word task. Accuracy on the task will be assessed.
Measured: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 1
Executive functioning will be assessed using a Spatial Working memory task. Reaction time on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 2
Executive functioning will be assessed using a Spatial Working memory task. Reaction time on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 3
Executive functioning will be assessed using a Spatial Working memory task. Reaction time on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 1
Executive functioning will be assessed using a Spatial Working memory task. Accuracy on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 2
Executive functioning will be assessed using a Spatial Working memory task. Accuracy on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 3
Executive functioning will be assessed using a Spatial Working memory task. Accuracy on this task will be measured.
Measured: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start5 Oct 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- 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
- Model description
- Following the first visit, participants will be randomly counterbalanced to one of the two conditions first (exercise, or control condition). Following completion of the first condition, the third visit will be completion of the other condition.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- North American Society for the Psychology of Sport and Physical Activity
- Responsible party
- Principal investigator, Jarod Vance, University of North Carolina, Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226039
- Sponsor's protocol ID
- FY22-134
- Status last verified
- Jun 2022
- First submitted
- 4 Oct 2021
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The current study is Jarod Vances' Dissertation project. A plan has not been created to share the data at this time due to the nature of the study having a very specific scope to be assessed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Bout of Aerobic Exercise on Cognition: The Moderating Role of Age
- ClinicalTrials.gov ID
- NCT05226039
- Acronym / sponsor ID
- FY22-134
- Conditions
- Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- North American Society for the Psychology of Sport and Physical Activity
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 7 Feb 2022 (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.
The current clinical study will have two groups of participants (young adults ages 20 - 30, and older adults ages 60 - 70) take part in three visits to the lab. On the first visit participants will fill out questionnaires assessing demographics and physical activity level. On the 2nd and 3rd visits participants will be engage in both a moderate intensity bout of aerobic exercise for 20 minutes, and 20 minutes of resting on a stationary bike watching an educational video. These two visits will be counterbalanced across age groups. Following both the exercise bout and the resting control condition participants will complete cognitive tasks assessing episodic memory and executive functioning. The first hypothesis is that older adults who are more physically active (assessed via questionnaire) will have significantly greater cognitive abilities compared to those who are less active or sedentary. The second hypothesis is that following a single bout of moderate intensity aerobic exercise, older adults will have a greater magnitude of change in their short-term memory, and long-term memory performance compared to younger adults.
Detailed description
Participants who express interest in the study will be contacted by telephone. During this phone call, the primary investigator will assess the inclusion/exclusion criteria (i.e., investigators will ask their age, if participants are willing to stay inactive during the required times, refrain from caffeine and food intake within an hour of every visit). Eligible participants will be scheduled for their 1st visit. On the first day of participation in the study, participants will read and sign the informed consent, complete questionnaires, and (to further assess their eligibility for both parts of the study) participants will perform the Montreal Cognitive Assessment, fill out a physical activity questionnaire, and complete a health history form (American College of Sports Medicine). On visit 1 participants will also complete cognitive tasks measuring memory and executive functioning. Investigators will assess resting heart rate by having participants put on a heart rate monitor to record R-R intervals (to assess heart rate variability) at rest for 5 minutes. If participants meet the eligibility requirements assessed on visit 1 (> 90 mins of physical activity/week) participants will qualify and be scheduled for visits 2 and 3.
During visits 2 and 3, participants will put on a heart rate monitor so that investigators can record their heart rate during the two conditions. Participants will then perform one of two conditions in a counterbalanced order. Participants will either rest for 25 minutes while watching an educational video, do the memory task, complete tasks measuring executive functioning (Stroop color word task, spatial working memory task), and do the recall task; or exercise for 25 min, do the memory task, complete the executive functioning tasks and do the recall task. The memory task is the Auditory Verbal Learning Test (AVLT) which consists of hearing and recalling a list of 15 words (List A) 5 times, hearing and recalling a different list of 15 words (List B), and then recalling List A. Participants will be audio recorded during the memory task to ensure that accurate scoring can be completed. The executive functioning tasks (Stroop, Spatial working memory task) will involve participants responding to stimuli on a computer via a keyboard. The Stroop task requires participants to respond to the color of stimuli that come up on the screen and the Spatial working memory task requires participants to remember the position of varying numbers of dots. The recall task involves participants recalling List A and then being asked to identify from a list of words those that came from List A or List B (recognition). The exercise consists of 5-min of warm-up followed by 20 min of moderate intensity exercise (55-65% heart rate reserve at 60-80 revolutions per minute). All exercise and rest periods will be on a cycle ergometer. During all memory tasks, there will be audio-taping. Subjects will be scheduled with a minimum of 48 hours between Day 1 and Day 2 and between Day 2 and Day 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following the first visit, participants will be randomly counterbalanced to one of the two conditions first (exercise, or control condition). Following completion of the first condition, the third visit will be completion of the other condition.
| Arm | Type | Receives |
|---|---|---|
| Young adult group | Other | Behavioral: Moderate intensity acute exercise boutOne group will consist of 20 to 30 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. |
| Older adult group | Other | Behavioral: Moderate intensity acute exercise boutThe other group will consist of 60 to 70 year olds. Participants will complete all three visits that include both the treatment (exercise visit) and the control (rest) visits. The treatment visit will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 to 30 years old for young adult group
- 60 to 70 years old for older adult group
- Cognitive normal (assessed via Montreal Cognitive Assessment on visit 1)
Key exclusion criteria (2 listed)
- Do not have any contraindications to exercise (assessed via American College of Sport Medicine Health screening form)
- No current musculoskeletal injuries
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 |
|---|---|---|
| Moderate intensity acute exercise boutThe treatment/intervention will consist of 20 minutes of moderate intensity aerobic exercise on a stationary bike. Intensity will be prescribed based off of heart rate reserve. | Behavioural | Older adult group, Young adult group |
Primary outcome
Episodic memory - Rey Auditory Verbal Learning Task Visit 1
Time frame: Approximately 20 minutes into visit 1.
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Episodic memory - Rey Auditory Verbal Learning Task Visit 2
Time frame: immediately following exercise or control (witnin 5 minutes)
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Episodic memory - Rey Auditory Verbal Learning Task Visit 3
Time frame: immediately following exercise or control (within 5 minutes)
The Rey Auditory Verbal Learning task (RAVLT) will assess single-item episodic memory. The number of words correctly recalled on 8 trials will be measured.
Episodic memory - Associative memory task Visit 1
Time frame: Approximately 45 minutes into visiti 1.
Participants will hear pairs of words read to them over an audio recording. Following this they will be asked to name the second word in each pair during recall. The number of words correctly recalled on 3 trials will be measured.
12 secondary outcomes
Executive functioning - Stroop reaction time Visit 1
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop reaction time Visit 2
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop reaction time Visit 3
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 1
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 2
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Stroop accuracy Visit 3
Time frame: Executive functioning will be measured 7 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 1
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 2
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory reaction time Visit 3
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 1
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 2
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
Executive functioning - Spatial working memory accuracy Visit 3
Time frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
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 24 Jun 2022.
- Individual participant dataSharing planned: Undecided. The current study is Jarod Vances' Dissertation project. A plan has not been created to share the data at this time due to the nature of the study having a very specific scope to be assessed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity acute exercise bout in people with Cognitive Performance, run by University of North Carolina, Greensboro at 1 site in United States.
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 3 inclusion and 2 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 24 Jun 2022. 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 United States. 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?
Episodic memory - Rey Auditory Verbal Learning Task Visit 1 (time frame: Approximately 20 minutes into visit 1.). The study lists 4 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 24 Jun 2022.