Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000434796
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
17/03/2022
Date last updated
5/05/2022
Date data sharing statement initially provided
17/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the supporting mechanisms of changes in neuropsychological function after stairclimbing in adults
Scientific title
Investigating the supporting mechanisms of neuropsychological function changes after stairclimbing in adults
Secondary ID [1] 306427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neuropsychological functioning 325262 0
Impaired cognition 325263 0
impaired mood 325463 0
Condition category
Condition code
Mental Health 322663 322663 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overview
Participants will come into a psychology lab at Otago University for three visits. Postgraduate students will be supervising and running each experiment. With the assistance of a research assistant who is trained in all relevant methods and procedures. Each session separated by 1 week. The sessions will last approximately (1 ½ hours). During two of the three visits, stair climbing (15 mins) will precede brain recordings (set up approx. 45 mins) collected during cognitive testing (10 mins). Testing will occur at the same time of day on all occasions, and the order of the visits will be randomized and counterbalanced across participants. The two stair climbing sessions will be identical except for the duration of stair climbing. Participants will receive course credits to encourage them to attend all three sessions.

Stair climbing
On two of the three visits, stair climbing will precede neuropsychological testing, entailing 3 x ascending and descending one flight of stairs. The protocol involves multiple phases: warm-up (2 min; moderate-paced climb up and down 18 stairs at a self-selected pace, followed by brisk walking on flat ground), [stair climbing (1 min), recovery (1 min) x either 2 or 5 repetitions], stair climbing (1 min), cool down (3 min). The recovery and cool down phases involve walking down stairs and on flat ground at a self-selected pace. Number of stairs climbed and heart rate will be recorded. One visit will entail the 3 x 1 min stair climbing protocol, and the other visit will entail 6 x 1 min stair climbing. Participants will be asked be self-report their perceived level of exertion using the Borg RPE scale. A 15-grade scale for of perceived exertion rated from, i.e., no exertion at all to maximal exertion. Instructions: “Climb up and down the stairs one step at a time for 1 min, ascending vigorously and descending as desired. Vigorous means relatively intense, but not all-out”. All aspects of the two stair climbing protocols will be identical except for the number of intense stair climbing intervals (3 or 6).

Neuropsychological Testing
Participants will perform a battery of neuropsychological tests ( assessing cognition and mood). Throughout testing, haemoglobin concentrations and electrical activity will be recorded concurrently. The cognitive tests involve viewing a display on a computer monitor and then pressing a button. The displays show simple shapes that are not in any way stressful, offensive, or unpleasant. The responses involve indicating the location or identity of a target stimulus. Each response and response latency will be recorded. Button presses will be made on a two-button response box. No visual or audio recordings are involved, and all recordings are completely non-invasive. The cognitive tests are not difficult or stressful and participants will be encouraged to rest as often as they please.

Hemoglobin concentrations and electrical activity measures
Concentrations of oxygenated and deoxygenated haemoglobin will be measured continuously using near-infrared spectroscopy (NIRS). This method assesses cerebral oxygenation changes. The NIRS technique is based on the relative transparency of human tissue to near-infrared light and on the oxygenation-dependent light absorption changes caused by the chromophores oxyhemoglobin [O2Hb] and deoxyhemoglobin [HHb]. It is completely non-invasive and painless. In the current experiment six pairs of transmitter-receiver optodes of the NIRS device will be attached to participants’ scalp according to the international 10/20 standard system. The distance between transmitter and receiver of each pair was three centimetres. The twelve optodes formed ten channels in total; two on bilateral frontal areas and eight on bilateral motor regions.

Concurrently with NIRS, the electrical activity of the brain will be recorded using electroencephalogram (EEG). EEG refers to recordings from multiple electrodes placed over the scalp, to record underlying electrical activity from the brain over a period of time (commonly referred to as brain waves). The EEG technique measures ionic current-voltage fluctuations which result from within the neurons of the brain. EEG is completely non-invasive and painless.
Intervention code [1] 322863 0
Prevention
Comparator / control treatment
Randomized controlled crossover trial

For the no stair climbing protocol, the participant will undertake seated rest for the same duration as the stair climbing protocols. Then identical to the active trials complete cognitive testing (10 mins) with concurrent brain recordings (set up approx. 45 min). The first experimental session will include completion of the 2018 census question on ethnicity, recording age, gender, years of education, any mental health diagnoses, medication (5 mins). Height and weight will be recorded to calculate BMI. The Mini Mental State Exam (MMSE) will be used for cognitive screening for anyone aged at least 50.
Control group
Active

Outcomes
Primary outcome [1] 330464 0
Change in haemoglobin during cognitive engagement as measured by NIRS.
Timepoint [1] 330464 0
Three visits separated by 1 week (session order which will be randomized and assessed during each task at each visit). For example,
Timepoint 1: Baseline (1 week post-enrolment)
Timepoint 2: 1 week post-stair climbing interval 3
Timepoint 3: 1 week post-stair climbing interval 6
Secondary outcome [1] 406324 0
Change in cognitive performance as assessed by increases in hemoglobin assessed using NIRS, specifically as task difficulty increases. Changes in cognitive performance will be assessed by a cognitive battery developed in the Machado lab, i.e., Pro, Anti, Pro/Anti; Simon; Flanker; Forward Spatial; Backwards Spatial; Digit Forward; Digit Backwards.
Timepoint [1] 406324 0
Three visits separated by 1 week (session order which will be randomized and assessed during each task at each visit). For example,
Timepoint 1: Baseline (1 week post-enrolment)
Timepoint 2: 1 week post-stair climbing interval 3
Timepoint 3: 1 week post-stair climbing interval 6

Eligibility
Key inclusion criteria
When participants come into the laboratory, they will be screened using the Adult pre-exercise screening system (APSS) to assess their current physical health and determine whether they are eligible to safely participate in this study. Eligibility to participate requires the participant to answer YES to the first 6 questions in stage 1.

The participant will be asked if they have normal or corrected-to-normal vision and no colour blindness
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Before being invited to come into the laboratory for testing, participants will be
screened to ensure they meet the following inclusion criteria:

- No neurological or psychiatric conditions (based on self-report)

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis
ANCOVA will be used, with significant covariates factored in, to determine whether oxygenated and total haemoglobin concentrations during cognitive engagement are enhanced on the stair climbing visits (cf control visit), and whether this is particularly true for one of the two stair climbing protocols. The primary outcome variable will be oxygenated haemoglobin and the secondary will be total haemoglobin. Follow-up t tests will compare the protocol with the best numerical outcome to the no stair climbing control condition and to the other active stair climbing condition. Drop outs will be replaced to ensure a fully counterbalanced design, which requires multiples of six. If any missing data is deemed not missing at random, care will be taken to characterize it relative to the other data. Our secondary hypothesis (linking the stair-climbing-induced enhancement of brain oxygenation, measured during cognitive engagement, to better cognitive performance) will be tested using correlation analyses (in line with our previous studies linking haemoglobin concentrations during cognitive engagement to better cognitive performance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
29/04/2022
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
22/12/2023
Actual
Sample size
Target
200
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 24580 0
New Zealand
State/province [1] 24580 0
Otago

Funding & Sponsors
Funding source category [1] 310776 0
University
Name [1] 310776 0
University of Otago
Country [1] 310776 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
William James Building 275 Leith Walk,
Dunedin North,
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 312015 0
Individual
Name [1] 312015 0
Wayne Meighan
Address [1] 312015 0
William James Building 275 Leith Walk,
Dunedin North,
Dunedin 9016
Country [1] 312015 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310351 0
University of Otago Human Ethics Committee
Ethics committee address [1] 310351 0
Ethics committee country [1] 310351 0
New Zealand
Date submitted for ethics approval [1] 310351 0
14/02/2022
Approval date [1] 310351 0
03/03/2022
Ethics approval number [1] 310351 0

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

Contacts
Principal investigator
Name 117342 0
A/Prof Liana Machado
Address 117342 0
University of Otago,
Psychology department,
William James Building 275 Leith Walk,
Dunedin North,
Dunedin 9016
Country 117342 0
New Zealand
Phone 117342 0
+64 03 479 7622
Fax 117342 0
Email 117342 0
[email protected]
Contact person for public queries
Name 117343 0
Liana Machado
Address 117343 0
University of Otago,
Psychology department,
William James Building 275 Leith Walk,
Dunedin North,
Dunedin 9016
Country 117343 0
New Zealand
Phone 117343 0
+64 03 479 7622
Fax 117343 0
Email 117343 0
[email protected]
Contact person for scientific queries
Name 117344 0
Liana Machado
Address 117344 0
University of Otago,
Psychology department,
William James Building 275 Leith Walk,
Dunedin North,
Dunedin 9016
Country 117344 0
New Zealand
Phone 117344 0
+64 03 479 7622
Fax 117344 0
Email 117344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15101Study protocol  [email protected]
15102Statistical analysis plan  [email protected]
15259Informed consent form  [email protected]



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.