Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000484145
Ethics application status
Approved
Date submitted
18/03/2019
Date registered
25/03/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Young Adults
Scientific title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Young Adults
Secondary ID [1] 297716 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 312032 0
Mood states 312033 0
Condition category
Condition code
Mental Health 310600 310600 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon arrival at the laboratory at the University, the participant will be asked to remain seated for 5 min to obtain a measure of resting heart rate. Following the 5-min resting period participants will receive verbal instructions regarding how to perform the ratings of perceived exertion (RPE) and the stair-climbing protocol, and watch a short demonstration video of the stair-climbing phase. Participants will then leave the testing room with the experimenter to complete the protocol. Further instructions are provided during the stair-climbing protocol. An adapted version of the 3 x 60-s 1F stair-climbing protocol from Allison et al. (2017) will be used. The number of stair-climbing intervals will be six, instead of three as in the original protocol by Allison et al. (2017). The protocol entail the following phases: 2-min warm up, 45-s instructional interval, 1-min stair climbing, 1-min recovery, 1-min stair climbing, 1-min recovery, 1-min stair climbing, 1-min recovery, 1-min stair climbing, 1-min recovery, 1-min stair climbing, 1-min recovery, 1-min stair climbing, and 3-min cool down. For the warm up, the participant walk at a moderate pace on a flat surface from the laboratory to the stairwell and then up two flights of 12 stairs (each 17 cm in height). The participant then walk at a brisk pace back and forth along the corridor for the remainder of the 2 min. During the 45-s instructional interval, the experimenter provide final instructions for the stair-climbing and recovery phases. The three stair-climbing phases are completed on one flight of 12 stairs, measuring 17 cm in height. Participants receive the following instruction adapted from Allison et al. (2017): “For the stair climbing please move vigorously. This means relatively intense but not all out, so please move up the stairs as fast as you can while taking one step at a time. Maintain control and safety at all times”. Each recovery phase involve the participant descending to the landing from their place on the stairs, and walking back and forth at a self-selected pace. RPE ratings are given immediately before (pre RPE) and after (post RPE) each stair-climbing interval. The cool down phase involve walking down two flights of stairs, then back and forth on a flat surface, all at a self-selected pace. Following cool down, the participant return to the testing room and sit for 5 min (seated rest), after which they begin the cognitive battery. Cognitive testing takes approximately 7 min. The duration between the stair-climbing session and control session is one week.

Reference
Allison, M. K., Baglole, J. H., Martin, B. J., Macinnis, M. J., Gurd, B. J., & Gibala, M. J. (2017). Brief intense stair climbing improves cardiorespiratory fitness. Medicine and Science in Sports and Exercise, 49(2), 298-307. doi:10.1249/MSS.0000000000001188
Intervention code [1] 313953 0
Behaviour
Comparator / control treatment
All aspects of the control session are identical to the stair-climbing session, except that following the initial 5-min resting period, the participant remain seated in the testing room for 5 min, after which they begin the cognitive battery. No stair-climbing intervals are performed during the control session.
Control group
Active

Outcomes
Primary outcome [1] 319448 0
Inhibitory control (Anti). Computerized reaction time task. Reaction times and cost scores are used as outcomes. To separate inhibitory control performance from visuomotor performance an inhibition cost score is calculated for each participant by subtracting reaction times from a visuomotor performance task (i.e., Pro) from inhibitory control (Anti) reaction times.

References
Guiney, H., Lucas, S. J., Cotter, J. D., & Machado, L. (2015). Evidence cerebral blood-flow regulation mediates exercise-cognition links in healthy young adults. Neuropsychology, 29(1), 1-9. 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 [1] 319448 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Primary outcome [2] 319449 0
Switching (Pro/Anti). Computerized reaction time task. Reaction times and cost scores are used as outcomes. To separate the switching component of the Pro/Anti task from visuomotor and inhibitory components, a switching cost measure is calculated for each participant by subtracting Anti reaction times from Pro/Anti reaction times..

References
Guiney, H., Lucas, S. J., Cotter, J. D., & Machado, L. (2015). Evidence cerebral blood-flow regulation mediates exercise-cognition links in healthy young adults. Neuropsychology, 29(1), 1-9. 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 [2] 319449 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [1] 368234 0
Mood state (sad) 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 [1] 368234 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [2] 368544 0
Mood state (energetic) 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 [2] 368544 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [3] 368545 0
Mood state (tense) 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 [3] 368545 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [4] 368546 0
Mood state (happy) 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 [4] 368546 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [5] 368547 0
Mood state (tired) 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 [5] 368547 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [6] 368548 0
Mood state (calm) 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 [6] 368548 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.

Eligibility
Key inclusion criteria
- Aged 18-24
- Normal or corrected-to-normal vision
- Readiness for physical activity (based on the Physical Activity Readiness Questionnaire (PARQ; Thomas, Reading, & Shephard, 1992)

Reference
Thomas, S., Reading, J., & Shephard, R. J. (1992). Revision of the Physical Activity Readiness Questionnaire (PAR-Q). Canadian Journal of Sport Sciences, 17(4), 338-345.
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Colour blindness
- Neurological or psychiatric conditions (based on self-report).

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary statistical analysis will be repeated measures ANCOVA (RM-ANCOVA) with follow-up t tests. In the RM-ANCOVAs self-reported physical activity will be included as a control variable and sex will be a between-subject factor. The same statistical analysis plan will be used for the cognitive outcomes and mood states.

In a previous study (Stenling et al., 2019) we found a session by sex interaction effect for switching (partial eta squared = 0.17) indicating that males performed better following the stair-climbing, whereas females did not. On average males had 44 milliseconds faster reaction times on the switching task following the stair-climbing compared to the control session. The difference in switching performance for females was on average 0.5 milliseconds between sessions. The power calculation for the current study is based on estimates from this previous study (Stenling et al., 2019) and we want to be able to detect a session by sex interaction effect of similar magnitude. Based on a power calculation using the GLIMMPSE software (Kreidler et al., 2013) with a desired power of 80%, an alpha level of 0.05, session as a within-subject factor, sex as a between-subject factor, and self-reported physical activity as a control variable, 60 participants (30 males, 30 females) are needed to detect a session by sex interaction effect with a similar magnitude as the interaction effect found in Stenling et al. (2019).

With 30 males and 30 females, a one-tailed alpha level of 0.05, and a desired power of 80%, we will be able to detect a medium-sized repeated measures main effect (Cohen's d = 0.50) within each sex group.

With a total of 60 participants, a one-tailed alpha level of 0.05, and a desired power of 80% power, we will be able to detect a small repeated measures main effect of the stair-climbing intervention (Cohen's d = 0.35).

Secondary statistical analyses are linear regression analyses to examine the influence of exercise intensity (as measured by % heart rate reserve) on inhibitory control, switching, and mood states. A power calculation using G*Power version 3.1.9.2 (Faul, Erdfelder, Lang, & Buchner, 2007) indicated that with three predictors (exercise intensity, self-reported physical activity, and sex), a desired power of 80%, and an alpha level of 0.05, we can detect a small effect size (f = 0.15) with a sample size of 60 participants.

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

Kreidler SM, Muller KE, Grunwald GK, Ringham BM, Coker-Dukowitz ZT, Sakhadeo UR, Barón AE, and Glueck DH (2013) GLIMMPSE: Online power computation for linear models with and without a baseline covariate. Journal of Statistical Software, 54(10). PMCID: PMC3882200

Stenling, A., Moylan, A., Fulton, E., & Machado, L. (2019). Effects of a brief stair-climbing intervention on cognitive performance and mood states in healthy young adults. Manuscript submitted for publication.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/03/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
25/07/2019
Date of last data collection
Anticipated
31/12/2019
Actual
1/08/2019
Sample size
Target
60
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 21345 0
New Zealand
State/province [1] 21345 0
Otago

Funding & Sponsors
Funding source category [1] 302243 0
University
Name [1] 302243 0
University of Otago
Country [1] 302243 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] 302098 0
Individual
Name [1] 302098 0
Andreas Stenling
Address [1] 302098 0
Department of Psychology
Umeå University, Mediagränd 14,
Beteendevetarhuset
901 87 Umeå SE
Country [1] 302098 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302919 0
University of Otago Human Ethics Committee
Ethics committee address [1] 302919 0
Ethics committee country [1] 302919 0
New Zealand
Date submitted for ethics approval [1] 302919 0
31/01/2019
Approval date [1] 302919 0
06/03/2019
Ethics approval number [1] 302919 0
18/012

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

Contacts
Principal investigator
Name 91850 0
A/Prof Liana Machado
Address 91850 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 91850 0
New Zealand
Phone 91850 0
+64 3 479 7622
Fax 91850 0
Email 91850 0
[email protected]
Contact person for public queries
Name 91851 0
Liana Machado
Address 91851 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 91851 0
New Zealand
Phone 91851 0
+64 3 479 7622
Fax 91851 0
Email 91851 0
[email protected]
Contact person for scientific queries
Name 91852 0
Liana Machado
Address 91852 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 91852 0
New Zealand
Phone 91852 0
+64 3 479 7622
Fax 91852 0
Email 91852 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 of 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 will be available from the principal investigator upon request.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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