Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000383965
Ethics application status
Approved
Date submitted
10/03/2020
Date registered
20/03/2020
Date last updated
18/05/2021
Date data sharing statement initially provided
20/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Young Adults: Dose-Response Relationships
Scientific title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Young Adults: Dose-Response Relationships
Secondary ID [1] 300720 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is an expansion of ACTRN12619000484145

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 316557 0
Mood states 316558 0
Condition category
Condition code
Mental Health 314795 314795 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 314796 314796 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will visit the laboratory on three separate occasions for a control session, a 3 x 60-s stair climbing session, and a 6 x 60-s stair-climbing session. Prior to their first visit they will be randomly assigned a session order. 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. During a stair-climbing session, following the 5-min resting period participants will receive verbal instructions regarding how to perform the ratings of perceived exertion (RPE) using Borg's (1998) RPE scale, 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) and Stenling et al. (2019) will be used. Participants will complete one session of 3 x 60-s 1F stair-climbing and one session of 6 x 60-s 1F stair-climbing, either one or two weeks apart (depending on their session order). The 3 x 60-s protocol includes the following phases: 2-min warm-up, 45-s instructional interval, 1-min stair climbing, 45-s recovery, 1-min stair climbing, 45-s recovery, 1-min stair climbing, and 3-min cool-down. The 6 x 60-s protocol includes the same phases, but with six stair-climbing intervals instead of three. For the warm-up, the participant walks 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 walks 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 provides final instructions for the stair-climbing and recovery phases. The 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 involves 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 involves 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 returns to the testing room and sits for 5 min (seated rest), after which they begin the cognitive battery. Cognitive testing takes approximately 7 min. The duration between each session (control, 3 x 60-s stair climbing, 6 x 60-s stair climbing) 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

Borg, G. (1998). Borg's perceived exertion and pain scales. Human kinetics.

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. Frontiers in Psychology, 10, 2300.
Intervention code [1] 317057 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] 323159 0
Inhibitory control (assessed via Anti task). Computerized reaction time task in which participants have to press a button on the opposite side of a red square that appears on a computer screen. Reaction times (ms) 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 (assessed via Pro task) from inhibitory control (Anti task) 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
Timepoint [1] 323159 0
Assessed at three time points (i.e., 3 x 60-s stair-climb, 6 x 60-s stair-climb, and control session), each one week apart.
Primary outcome [2] 323160 0
Switching ability (assessed via Pro/Anti task). Computerized reaction time task in which participants press a button on the same side as green squares and on the opposite side of red squares that appear on a computer screen. Reaction times (ms) 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] 323160 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control) each one week apart.
Secondary outcome [1] 380973 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] 380973 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control) each one week apart
Secondary outcome [2] 380986 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] 380986 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control), each one week apart.
Secondary outcome [3] 380987 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] 380987 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control), each one week apart.
Secondary outcome [4] 380988 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] 380988 0
Assessed at three time points (i..e, 3 x 60-s stair climb, 6 x 60-s stair climb, and control), each one week apart.
Secondary outcome [5] 380989 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] 380989 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control), each one week apart.
Secondary outcome [6] 380990 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] 380990 0
Assessed at three time points (i.e., 3 x 60-s stair climb, 6 x 60-s stair climb, and control), each one week apart.

Eligibility
Key inclusion criteria
- Aged 18-30
- Normal or corrected-to-normal vision
- Readiness for physical activity, based on the Physical Activity Readiness Questionaire (PAR-Q; 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
30 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
We will use a repeated measures analysis of variance with follow-up t-tests to determine whether cognitive performance and mood were superior during the stair climbing visits relative to the no stair climbing visit, and whether cognitive performance and mood were superior during the 6 x 60-s stair climbing session compared to the 3 x 60-s stair climbing session. Cognitive performance will be indicated by accuracy-adjusted reaction times (by dividing median reaction times on correct trials by the proportion of accurate responses). Dropouts will be replaced to ensure a fully counterbalanced design within each sex group. If any missing data is deemed not missing at random, care will be taken to characterize it relative to other data.

The power analysis for the current study is based on data and effect sizes reported by Stenling et al. (2019) as well as (as of yet) unpublished data using the 6 x 60-s stair climbing protocol. We used GLIMMPSE (Kreidler et al., 2013) with a desired power of 80%, an alpha level of 0.05, sex as a between-subjects factor, and session and cognitive test as within-subjects factors, which indicated 48 participants (24 males, 24 females) are needed to detect a sex x session x cognitive test interaction effect. Additional analyses using G*Power (Faul et al., 2007) indicated that with a total sample size of 48 participants, we will be able to detect a medium (np2 = 0.06) repeated measures main effect of the stair climbing intervention and the cognitive tests. With 24 males and 24 females, we will be able to detect a medium-sized (np2 = 0.06) sex x session and sex x cognitive test interaction with 80% power.


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, S. M., Muller, K. E., Grunwald, G. K., Ringham, B. M., Coker-Dukowitz, Z. T., Sakhadeo, U. R., Barón, A. E., and Glueck, D. H. (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. Frontiers in Psychology, 10:2300. doi: 10.3389/fpsyg.2019.02300

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2020
Date of last participant enrolment
Anticipated
17/12/2020
Actual
4/09/2020
Date of last data collection
Anticipated
31/12/2020
Actual
21/09/2020
Sample size
Target
48
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 22427 0
New Zealand
State/province [1] 22427 0
Otago

Funding & Sponsors
Funding source category [1] 305164 0
University
Name [1] 305164 0
University of Otago
Country [1] 305164 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] 305560 0
None
Name [1] 305560 0
Address [1] 305560 0
Country [1] 305560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305531 0
University of Otago Human Ethics Committee
Ethics committee address [1] 305531 0
Ethics committee country [1] 305531 0
New Zealand
Date submitted for ethics approval [1] 305531 0
Approval date [1] 305531 0
26/02/2018
Ethics approval number [1] 305531 0
18/012

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

Contacts
Principal investigator
Name 100690 0
A/Prof Liana Machado
Address 100690 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 100690 0
New Zealand
Phone 100690 0
+64 3 479 7622
Fax 100690 0
Email 100690 0
[email protected]
Contact person for public queries
Name 100691 0
Liana Machado
Address 100691 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 100691 0
New Zealand
Phone 100691 0
+64 3 479 7622
Fax 100691 0
Email 100691 0
[email protected]
Contact person for scientific queries
Name 100692 0
Liana Machado
Address 100692 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 100692 0
New Zealand
Phone 100692 0
+64 3 479 7622
Fax 100692 0
Email 100692 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 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.