- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05226039
The Effects of a Single Bout of Aerobic Exercise on Cognition: The Moderating Role of Age
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Greensboro, North Carolina, United States, 27402
- University of North Carolina at Greensboro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Do not have any contraindications to exercise (assessed via American College of Sport Medicine Health screening form)
- No current musculoskeletal injuries
Study Plan
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 |
|---|---|
|
Other: Young adult group
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.
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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.
|
|
Other: Older adult group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Approximately 20 minutes into visit 1.
|
|
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.
|
immediately following exercise or control (witnin 5 minutes)
|
|
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.
|
immediately following exercise or control (within 5 minutes)
|
|
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.
|
Approximately 45 minutes into visiti 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 will be assessed using a Stroop Color Word task.
Reaction time will be assessed.
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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 will be assessed using a Stroop Color Word task.
Reaction time will be assessed.
|
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 will be assessed using a Stroop Color Word task.
Reaction time will be assessed.
|
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 will be assessed using a Stroop Color Word task.
Accuracy on the task will be assessed.
|
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 will be assessed using a Stroop Color Word task.
Accuracy on the task will be assessed.
|
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 will be assessed using a Stroop Color Word task.
Accuracy on the task will be assessed.
|
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 will be assessed using a Spatial Working memory task.
Reaction time on this task will be 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
Time Frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
|
Executive functioning will be assessed using a Spatial Working memory task.
Reaction time on this task will be 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
Time Frame: Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
|
Executive functioning will be assessed using a Spatial Working memory task.
Reaction time on this task will be measured.
|
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 will be assessed using a Spatial Working memory task.
Accuracy on this task will be measured.
|
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 will be assessed using a Spatial Working memory task.
Accuracy on this task will be measured.
|
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.
|
Executive functioning will be assessed using a Spatial Working memory task.
Accuracy on this task will be measured.
|
Executive functioning will be measured 12 minutes after completion of the exercise or control conditions.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FY22-134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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