Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001514897
Ethics application status
Approved
Date submitted
28/09/2021
Date registered
5/11/2021
Date last updated
5/11/2021
Date data sharing statement initially provided
5/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating how an exercise intervention influences sleep, and memory and thinking skills, in healthy older adults with poor sleep.
Scientific title
The Impact of a High Intensity Acute Exercise intervention on sleep and cognition in older adults experiencing poor sleep.
Secondary ID [1] 305393 0
None
Universal Trial Number (UTN)
Trial acronym
HIAESC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 323750 0
Poor sleep 324217 0
Condition category
Condition code
Mental Health 321273 321273 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 321556 321556 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 321557 321557 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants complete a triple baseline assessment for the current study, with baseline sessions separated by approximately one week. In the first and third baseline assessments, participants first complete the cogstate cognitive battery, and subsequently undergo a maximal fitness test conducted on a stationary bicycle. During the fitness test, participants cycle at varying intensities and wear a specially designed mask which measures their breathing rate. At the second baseline assessment participants complete only the cogstate cognitive battery and the Montreal Cognitive Assessment (MoCA). After baseline assessments are complete, there is approximately 7 days until the intervention sessions, which are conducted in a counter balanced order.

The intervention for the current study is a high-intensity interval exercise (HIIE) intervention, designed as a cross-over trial. The intervention will be conducted on a stationary bicycle ergometer and will consist of 10x 1 minute bouts at 80% of individual peak aerobic power (produced in a baseline fitness assessment), interspersed by 1 minute of active recovery at 40% of their peak aerobic power, resulting in a total of 20 minutes cycling. The intervention is delivered under the supervision of a trained and accredited exercise physiologist. The intervention session will be conducted individually for each participant at Murdoch University, and participants will only receive the intervention once. There will be a wash out period of approximately seven days between the control and intervention conditions.
Intervention code [1] 321813 0
Lifestyle
Comparator / control treatment
The study is a cross over design, each participant will receive both the intervention and control condition. The control session is conducted exactly the same way as the intervention session, however instead of cycling, participants will sit quietly in a room for 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 329066 0
The primary outcome for this study is the associations between changes in sleep (measured via WatchPAT) and changes in cognitive function (on the cogstate cognitive battery) due to an acute high intensity exercise intervention.
Timepoint [1] 329066 0
Objective sleep measurement (WatchPAT) completed at baseline (5 nights of data), the night after the intervention, and the night after the control.
Cognitive function (cogstate) completed at baseline, immediately after the control and immediately after the intervention, and 24-hours post control and post-intervention.
Primary outcome [2] 329067 0
The effect of acute exercise on cognitive function (measured via the cogstate cognitive battery) immediately post exercise.
Timepoint [2] 329067 0
baseline - post intervention session
baseline - post control session
Primary outcome [3] 329068 0
The effect of acute high intensity exercise on objective sleep (measured via WatchPAT) the night following exercise
Timepoint [3] 329068 0
baseline - post intervention session
baseline - post control session
Secondary outcome [1] 401338 0
Reliability of the cogstate cognitive battery assessed by analysing the consistency of results on outcome measures across the three baseline assessments.
Timepoint [1] 401338 0
Triple baseline assessments (separated by approximately 7 days)
Secondary outcome [2] 401339 0
Reliability of a cycling based maximal fitness test in older adults by examining the intra-class correlation between the results of the two assessments.
Timepoint [2] 401339 0
Double baseline measure (separated by approximately 14 days)
Secondary outcome [3] 402135 0
Practice effects on the cogstate cognitive battery. These will be assessed by examining the change in performance over the triple baseline assessment.
Timepoint [3] 402135 0
Triple baseline assessment (each separated by 7 days)

Eligibility
Key inclusion criteria
Cognitively healthy older adults aged 60-80, defined as 'poor sleepers' based on scores from the Pittsburgh Sleep Quality Index. Individuals who are physically active (150 minutes of moderate intensity exercise per week), but not currently engaged in high intensity exercise.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or cognitive decline
Uncontrolled depression
Uncontrolled Sleep Apnoea
Uncontrolled hypertension
Stent or pacemaker
History of severe neurological conditions
Cancer in last 2 years
Insulin dependent diabetes
Alcohol: >14 / >28 units per week

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
G*Power software was used to determine the required sample size for the study analysis. To detect an effect size of f =.35, based on literature examining the relationship between acute exercise and sleep (Larsen et al., 2019), and acute exercise and cognition (Ludyga, Gerber, Brand, Holsboer-Trachsler, & Pühse, 2016), at a power of .8, with an error of .05, the required sample is 16 participants. This study aims to recruit 30 participants and will be adequately powered for the main analysis.
A repeated measures linear model will be conducted using time
(baseline or post-exercise) and condition (control, HIIE) as within-subjects variables, and
cognition as the dependent variable. Separate models will be run for each cognitive
outcome at each timepoint (immediately following exercise and 24-hours post exercise). Another repeated measures analysis will be conducted, using time (baseline
or post-exercise) and condition (control, HIIE) as within subject variables, and sleep outcomes
as the dependent variable. Finally, a mediation analysis will be conducted to examine whether acute exercise improves sleep, and in turn, cognitive function. All analyses will be conducted using R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/08/2021
Date of last participant enrolment
Anticipated
15/12/2021
Actual
Date of last data collection
Anticipated
15/02/2022
Actual
Sample size
Target
30
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 309756 0
University
Name [1] 309756 0
Murdoch University
Country [1] 309756 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, Western Australia, 6150
Country
Australia
Secondary sponsor category [1] 310822 0
None
Name [1] 310822 0
Address [1] 310822 0
Country [1] 310822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309512 0
Murdoch University Human Resources and Ethics Committee
Ethics committee address [1] 309512 0
Ethics committee country [1] 309512 0
Australia
Date submitted for ethics approval [1] 309512 0
17/11/2020
Approval date [1] 309512 0
03/02/2021
Ethics approval number [1] 309512 0
2020/207

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

Contacts
Principal investigator
Name 114414 0
Dr Belinda Brown
Address 114414 0
90 South Street, Murdoch University, Murdoch, Western Australia, 6150
Country 114414 0
Australia
Phone 114414 0
+61 412848985
Fax 114414 0
Email 114414 0
[email protected]
Contact person for public queries
Name 114415 0
Kelsey Sewell
Address 114415 0
90 South Street, Murdoch University, Murdoch, Western Australia, 6150
Country 114415 0
Australia
Phone 114415 0
+61457673728
Fax 114415 0
Email 114415 0
[email protected]
Contact person for scientific queries
Name 114416 0
Kelsey Sewell
Address 114416 0
90 South Street, Murdoch University, Murdoch, Western Australia, 6150
Country 114416 0
Australia
Phone 114416 0
+61457673728
Fax 114416 0
Email 114416 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?

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.