Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001690145
Ethics application status
Approved
Date submitted
25/11/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Older Adults
Scientific title
Effects of a Brief Stair-Climbing Intervention on Cognitive Performance and Mood States in Healthy Older Adults
Secondary ID [1] 299629 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 314946 0
Mood states 314947 0
Condition category
Condition code
Mental Health 313293 313293 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 313701 313701 0 0
Studies of the normal brain and nervous system

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) 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) 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

Borg, G. (1998). Borg's perceived exertion and pain scales. Human kinetics.
Intervention code [1] 315884 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] 321774 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

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] 321774 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Primary outcome [2] 321775 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] 321775 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [1] 376168 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] 376168 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [2] 376169 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] 376169 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [3] 376170 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] 376170 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [4] 376171 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] 376171 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [5] 376172 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] 376172 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.
Secondary outcome [6] 376173 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] 376173 0
Assessed at two time points (i.e., stair-climb and control session), one week apart.

Eligibility
Key inclusion criteria
- Aged 65-74
- 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
65 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Colour blindness
- Neurological or psychiatric conditions (based on self-report and scores from the Mini-Mental State Examination)

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 an Analysis of Covariance (ANCOVA), with significant covariates factored in, to determine whether cognitive performance and mood was superior during the stair climbing visit relative to the no stair climbing visit. Cognitive performance will be indicated by accuracy-adjusted reaction times (by dividing median reaction times on correct trials by the proportion of accurate responses). Drop outs 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 study that established the stair climbing protocol showed significant cardiorespiratory effects with only 6 to 9 young women per group (Allison et al. 2017); however, we have larger sample sizes planned as the cognitive effects may be less robust. A power analysis using the effect size reported by Ludyga et al. (2016) for acute cognitive benefits following moderate aerobic exercise in older adults (g = .67) indicates that to achieve 80% power for ANCOVA, 20 participants would be required given 0 to 1 identified covariates, and 21 participants would be required given 2 to 6 identified covariates. To allow for a fully counterbalanced design, while ensuring sufficient power, we will plan for a group size of 24 participants. Given that our initial study in young adults indicated sex differences (Stenling et al., 2019), we will aim to achieve a final total sample size of n = 48 (24 in each sex group). This sample size should be sufficient based on past studies that reported cognitive benefits following an acute bout of moderate exercise (Hyodo et al., 2012; Yanagisawa et al., 2010). The crossover design helps limit variability associated with interindividual differences.

References
Allison MK, Baglole JH, Martin BJ, Macinnis MJ, Gurd BJ, Gibala MJ. Brief Intense Stair Climbing Improves Cardiorespiratory Fitness. Med Sci Sports Exerc. 2017;49(2):298-307.

Hyodo K, Dan I, Suwabe K, et al. Acute moderate exercise enhances compensatory brain activation in older adults. Neurobiol Aging. 2012;33(11):2621-2632.

Ludyga S, Gerber M, Brand S, Holsboer-Trachsler E, Puhse U. Acute effects of moderate aerobic exercise on specific aspects of executive function in different age and fitness groups: A meta-analysis. Psychophysiology. 2016;53(11):1611-1626.

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

Yanagisawa H, Dan I, Tsuzuki D, et al. Acute moderate exercise elicits increased dorsolateral prefrontal activation and improves cognitive performance with Stroop test. Neuroimage. 2010;50(4):1702-1710.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/11/2019
Date of last participant enrolment
Anticipated
17/02/2020
Actual
Date of last data collection
Anticipated
28/02/2020
Actual
Sample size
Target
48
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 21961 0
New Zealand
State/province [1] 21961 0
Otago

Funding & Sponsors
Funding source category [1] 304105 0
University
Name [1] 304105 0
University of Otago
Country [1] 304105 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] 304677 0
None
Name [1] 304677 0
Address [1] 304677 0
Country [1] 304677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304593 0
University of Otago Human Ethics Committee
Ethics committee address [1] 304593 0
Ethics committee country [1] 304593 0
New Zealand
Date submitted for ethics approval [1] 304593 0
Approval date [1] 304593 0
26/02/2018
Ethics approval number [1] 304593 0
18/012

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

Contacts
Principal investigator
Name 97514 0
A/Prof Liana Machado
Address 97514 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 97514 0
New Zealand
Phone 97514 0
+64 3 479 7622
Fax 97514 0
Email 97514 0
[email protected]
Contact person for public queries
Name 97515 0
Liana Machado
Address 97515 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 97515 0
New Zealand
Phone 97515 0
+64 3 479 7622
Fax 97515 0
Email 97515 0
[email protected]
Contact person for scientific queries
Name 97516 0
Liana Machado
Address 97516 0
Department of Psychology
Brain Health Research Centre
University of Otago
PO Box 56
Dunedin 9054
NEW ZEALAND
Country 97516 0
New Zealand
Phone 97516 0
+64 3 479 7622
Fax 97516 0
Email 97516 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

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No documents have been uploaded by study researchers.

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