Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000242820
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
8/03/2021
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of chronic exercise on cognitive function in healthy young adults.
Scientific title
A randomised controlled trial investigating the effects of chronic exercise on the neurophysiological function of healthy young adults
Secondary ID [1] 302893 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 319896 0
Mood States 319897 0
Condition category
Condition code
Mental Health 317832 317832 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 317833 317833 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to attend the laboratory for two testing sessions (approximately 50 minutes - 1 hour) which will assess cognitive function, mood and fitness. Participants recruited will be sedentary (i.e., not exercising more than twice a week). A 3:1 ratio assignment to either the exercise or control group will be used. Those assigned to the exercise group will be asked to complete a six-week running regime which has been adapted from the protocol used in Stroth et al., (2009). The exercise group will be asked to run (or walk vigorously or jog if they are unable to run at first) at least 3 times a week for a period of 30 minutes at a time. Participants will be advised that they must warm up and cool down appropriately when completing their running session and that they should only engage in exercise if it is safe for them to do so (e.g., not running if they feel unwell and being aware of their surroundings when running). During the exercise session, participants should ensure that their breathing and heart rate increases. The control group will be asked to maintain their normal routine, with no additional exercise. Both groups will be asked to keep an exercise diary to record exercise sessions. This diary asks for details of the environmental conditions of the exercise as well as the dates and time. The experimental group will be required to record the details of their regime and any additional exercise they take part in during the week whereas the control group will just be asked to record any details of exercise that they take part in during the week. The diary will be sent to them at the beginning of each week and participants will be asked to send it back at the end of the week. Following the completion of the six-week period, participants will be asked to attend the second testing session.

Participants will be recruited until 23/04/2021 such that the final data collection date will be 04/06/2021. However, if 80 participants (control = 20, runners = 60) are not completed in this time the trial will continue. In this case, recruitment will continue until 16/07/2021 and the final data collection date will be 27/08/2021.

References
Stroth, S., Hille, K., Spitzer, M., & Reinhardt, R. (2009). Aerobic endurance exercise benefits memory and affect in young adults. Neuropsychological Rehabilitation, 19(2), 223-243. https://doi.org/10.1080/09602010802091183
Intervention code [1] 319179 0
Behaviour
Comparator / control treatment
The control group will be exposed to comparable testing conditions as the exercise group in relation to the cognitive, fitness and mood testing as well as the lifestyle questionnaires and completion of an exercise diary. However, the control group will be asked to maintain their normal daily routine during the six-week period.
Control group
Active

Outcomes
Primary outcome [1] 325864 0
Visuospatial short-term memory (Forward Spatial). Computerised recall task. Participants will be shown nine boxes which will light up in an increasing sequence and will be asked to recall them in the order shown.
Total score (i.e., the product of the maximum span and the total number of sequences recalled correctly) will be used as the outcome.


References
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: Performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4), 539-549. doi:10.1037/pas0000503
Timepoint [1] 325864 0
Assessed at pre-intervention (baseline) and at follow up (six weeks after baseline)
Primary outcome [2] 325868 0
Positive Affect (PANAS). A questionnaire that asks the extent to which a positive or negative mood (e.g., distressed, proud, alert, irritable) is felt. Responses are given on five point range from not at all to extremely. Positive mood scores will be used as outcomes.

References
Stroth, S., Hille, K., Spitzer, M., & Reinhardt, R. (2009). Aerobic endurance exercise benefits memory and affect in young adults. Neurpsychological Rehabilitation, 19(2), 223-243. https://doi.10.1080/09602010802091183
Timepoint [2] 325868 0
Assessed at baseline and at follow up (six weeks after baseline)
Primary outcome [3] 325885 0
Negative Affect (PANAS). A questionnaire that asks the extent to which a positive or negative mood (e.g., distressed, proud, alert, irritable) is felt. Responses are given on five point range from not at all to extremely. Negative mood scores will be used as outcomes.

References
Stroth, S., Hille, K., Spitzer, M., & Reinhardt, R. (2009). Aerobic endurance exercise benefits memory and affect in young adults. Neuropsychological Rehabilitation, 19(2), 223-243. https://doi.10.1080/09602010802091183
Timepoint [3] 325885 0
Assessed at baseline and at follow up (six weeks after baseline)
Secondary outcome [1] 389368 0
Visuospatial Working Memory (Backward Spatial). Computerised recall task. Participants will be shown boxes that will light up in increasing sequences and will be asked to recall them in the reverse order.
Total score (i.e., the product of the maximum span and the total number of sequences recalled correctly) will be used as the outcome.


References
White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: Performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4), 539-549. doi:10.1037/pas0000503
Timepoint [1] 389368 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [2] 389375 0
Verbal short-term memory (Forward digit). Computerised recall task. Participants will be shown increasing sequences of digits and be asked to recall them in the same order they were shown.
Total score (i.e., the product of the maximum span and the total number of sequences recalled correctly) will be used as the outcome.


References
White, N., Naldoza-Drake, P., Black, K., Scullion, L., & Machado, L. (2018). Can improving the nutritional content of bread enhance cognition? Cognitive outcomes from a randomized controlled trial. Journal of Cognitive Enhancement, 4(2), 167-178.
https://doi.org/10.1007/s41465-019-00149-0
Timepoint [2] 389375 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [3] 389419 0
Verbal working memory (Backward Digit). Computerised recall task. Participants will be shown increasing sequences of digits and be asked to recalled them backwards.
Total score (i.e., the product of maximum span and the total number of sequences remembered correctly) will be used as the outcome.

References
White, N., Naldoza-Drake, P., Black, K., Scullion, L., & Machado, L. (2018). Can improving the nutritional content of bread enhance cognition? Cognitive outcomes from a randomized controlled trial. Journal of Cognitive Enhancement, 4(2), 167-178.
https://doi.org/10.1007/s41465-019-00149-0
Timepoint [3] 389419 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [4] 389421 0
Cognitive Flexibility (Pro/Anti). Computerised reaction time task. Reaction Time will be used as the main outcome variable for this task. It is expected that there will be ceiling accuracy scores, however accuracy rates will be checked to ensure that they do not show changes that contradict the correct response latency data. Should this occur, a combined measure may be used instead called accuracy adjusted reaction time.

References
Guiney, H., Lucas, S., Cotter, J., & Machado, L. (2015). Evidence cerebral blood-flow regulation mediates exercise-cognition links in healthy young adults. Neuropsychology, 29(1), 1-9. https://doi. 10.1037/neu0000124

White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: Performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4), 539-549. doi:10.1037/pas0000503
Timepoint [4] 389421 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [5] 389422 0
Basic visuomotor skills (Pro). Computerised reaction time task. Reaction time will be used as the main outcome variable for this task. It is expected that there will be ceiling accuracy scores, however accuracy rates will be checked to ensure that they do not show changes that contradict the correct response latency data. Should this occur, a combined measure may be used instead called accuracy adjusted reaction time.

References
Guiney, H., Lucas, S., Cotter, J., & Machado, L. (2015). Evidence cerebral blood-flow regulation mediates exercise-cognition links in healthy young adults. Neuropsychology, 29(1), 1-9. https://doi. 10.1037/neu0000124

White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: Performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4), 539-549. doi:10.1037/pas0000503
Timepoint [5] 389422 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [6] 389423 0
Inhibitory control (Anti). Computerised reaction time task. Reaction time be used as the main outcome. It is expected that there will be ceiling accuracy scores, however accuracy rates will be checked to ensure that they do not show changes that contradict the correct response latency data. Should this occur, a combined measure may be used instead called accuracy adjusted reaction time.
References
Guiney, H., Lucas, S., Cotter, J., & Machado, L. (2015). Evidence cerebral blood-flow regulation mediates exercise-cognition links in healthy young adults. Neuropsychology, 29(1), 1-9. https://doi. 10.1037/neu0000124

White, N., Forsyth, B., Lee, A., & Machado, L. (2018). Repeated computerized cognitive testing: Performance shifts and test-retest reliability in healthy young adults. Psychological Assessment, 30(4), 539-549. doi:10.1037/pas0000503
Timepoint [6] 389423 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [7] 389424 0
Fitness (YMCA 3-minute step test). Participants are asked to step up and down on a 30cm step for a period of 3 minutes whilst maintaining a pace of 96 beats per minute. Cumulative heart rate 1 minute post test will be used as outcome. A Polar M430 heart rate watch will be used to collect the heart rate data throughout the test and for the period after the test. The data will later be assessed in order to gain the necessary results i.e. the heart rate at 1 minute post test.


References
Bohannon, R., Bubela, D., Wang, Y., Magasi, S., & Gershon, R. (2015). Six-minute walk test vs. three-minute step test for measuring functional endurance. Journal of Strength and Conditioning Research, 29(11), 3240-3244.
Timepoint [7] 389424 0
Assessed at baseline and at follow up (six weeks after baseline).
Secondary outcome [8] 389425 0
Environmental conditions (Exercise diary). Participants will fill out a diary which describes the environmental conditions of their exercise session (e.g., indoors/outdoors). The environmental conditions will be coded and used as outcomes (this is dependent on variability within the exercise group).
Timepoint [8] 389425 0
Assessed throughout the six-week exercise period.
Secondary outcome [9] 390618 0
Exercise enjoyment will be assessed using the Visual Analogue Mood Scales (VAMS).

The response is given on a 0 (Not at all) to 100 (Extremely) visual analogue scale.

Reference
Machado, L., Thompson, L. M., & Brett, C. H. (2018). Visual analogue mood scale scores in healthy young versus older adults. International Psychogeriatrics, 1-8. doi:10.1017/S1041610218000996
Timepoint [9] 390618 0
At the second testing session, six weeks after the beginning of the exercise regime.

Eligibility
Key inclusion criteria
Between the ages of 18-30 years
Normal or corrected-to-normal vision
Currently sedentary (e.g., not exercising more than twice a week)
Physically capable of running or jogging
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Colour blindness

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will use a 2 group (control, exercise) x 2 time (pre, post) mixed model ANOVA to assess whether cognitive and mood benefits are superior in the exercise group. A correlational analysis will be conducted to determine whether there is a relationship between increases in fitness in the exercise group and changes in cognitive function and mood. It may also be necessary to determine whether there is a dose effect of exercise on cognitive function and mood. However, this is dependent on whether the runners show variance in how much they run.
The power analysis for the current study is based on data and effect sizes reported by Stroth et al., (2009). We used G*Power (Faul et al., 2007) with a desired power level of 80%, alpha level of 0.05, group as the between-subjects factor and time as the within-subjects factor which indicated that 20 participants (10 control, 10 exercise group) were required for a group x time interaction effect with an effect size of np2 = 0.23.

References
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G* Power 3: A flexible statistical power analysis program for the social, behavioural, and biomedical sciences. Behaviour Research Methods, 39(2), 175-191. https://doi.org/10.3758/BF03193146

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2021
Actual
Date of last participant enrolment
Anticipated
16/07/2021
Actual
Date of last data collection
Anticipated
27/08/2021
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 23235 0
New Zealand
State/province [1] 23235 0
Otago

Funding & Sponsors
Funding source category [1] 307317 0
University
Name [1] 307317 0
University of Otago
Country [1] 307317 0
New Zealand
Funding source category [2] 307973 0
University
Name [2] 307973 0
University of Otago
Country [2] 307973 0
New Zealand
Primary sponsor type
Individual
Name
Liana Machado
Address
Department of Psychology
University of Otago
362 Leith Street,
Dunedin 9016.
PO Box 56,
Dunedin 9054,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 307953 0
None
Name [1] 307953 0
Address [1] 307953 0
Country [1] 307953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307407 0
University of Otago Human Ethics Committee
Ethics committee address [1] 307407 0
Ethics committee country [1] 307407 0
New Zealand
Date submitted for ethics approval [1] 307407 0
27/11/2020
Approval date [1] 307407 0
10/12/2020
Ethics approval number [1] 307407 0
20/128

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107126 0
A/Prof Liana Machado
Address 107126 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107126 0
New Zealand
Phone 107126 0
+64 3 479 7622
Fax 107126 0
Email 107126 0
[email protected]
Contact person for public queries
Name 107127 0
Liana Machado
Address 107127 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107127 0
New Zealand
Phone 107127 0
+64 3 479 7622
Fax 107127 0
Email 107127 0
[email protected]
Contact person for scientific queries
Name 107128 0
Liana Machado
Address 107128 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 107128 0
New Zealand
Phone 107128 0
+64 3 479 7622
Fax 107128 0
Email 107128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Data will be made available to researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data can be obtained from the principal investigator upon request via email ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.