Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000476730
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
25/03/2022
Date last updated
25/03/2022
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the impacts of sustained exercise on cognition
Scientific title
Examining the impacts of sustained exercise on cognition: A feasibility study
Secondary ID [1] 303241 0
None
Universal Trial Number (UTN)
U1111-1264-1162
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 320407 0
Alzheimer's disease 320408 0
Mild cognitive impairment 320409 0
Subjective cognitive decline 320410 0
Condition category
Condition code
Neurological 318312 318312 0 0
Dementias
Neurological 318313 318313 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise delivery: All exercise will be delivered by an accredited exercise physiologist (AEP) or physiotherapist in a group setting (3-5 participants per session). Attendance and exercise completion records will be kept to monitor adherence to the intervention.

High-intensity program (HIP) group: Individuals allocated to this group will complete three exercise and education sessions per week during the three-month Supervised exercise block. This will be followed by a nine-month unsupervised maintenance period, where participants will be provided with a gym membership and receive regular check-ins by exercise professionals.

During the three months of supervised exercise, the intent is for participants in HIP to reach a minimum of 90 minutes of aerobic high-intensity interval training per week delivered on a stationary bike. Aerobic exercise intensity will be set using the Borg scale of perceived exertion (17 to 19 during intervals). In addition to the aerobic exercise, participants will undertake a progressive resistance training program of 40 minutes of progressive resistance exercise targeting major muscle groups and 30 minutes of education relating to healthy lifestyle habits per week. Thus, participants will attend two 50 minute sessions per week (aerobic and resistance training) and one 60 minute session per week (aerobic training and education).

Moderate-intensity program (MIP) group: Individuals allocated to this group will complete three exercise and education sessions per week during the three-month Supervised exercise block. This will be followed by a 9 month unsupervised maintenance period, where participants will be provided with a gym membership and receive regular check-ins by exercise professionals.

The intent is for participants in MIP to reach a minimum of 150 minutes of aerobic moderate-intensity exercise per week. Aerobic exercise intensity will be set using the Borg scale of perceived exertion (13 to 14). In addition to the aerobic exercise, participants will undertake a progressive resistance training program of 40 minutes of progressive resistance exercise and 30 minutes of education relating to healthy lifestyle habits, per week. Thus, participants will attend two 70 minute sessions per week (aerobic and resistance training) and one 80 minute session per week (aerobic training and education).

Unsupervised maintenance period: Participants will be provided with written programmes to follow during the unsupervised portion of this intervention, with the aim of achieving similar intensities of exercise to what will be delivered during the supervised portion. An AEP will regularly check-in with participants (monthly) to discuss their exercise programmes. Our research team will have access to gym attendance records, and participants will wear a FitBit activity monitor throughout this portion of the intervention.

Education: The education sessions have been developed to both educate and create long-term behavioural change in our participants. Participants will receive 30 minutes of education, one day a week (delivered by AEP, physiotherapist, or psychologist). These sessions will include information regarding healthy behaviours and group sessions addressing barriers to behaviour change. In addition, 1 hour educational seminars will be delivered on three occasions during the Maintenance portion of the programs, which will continue to encourage exercise levels commensurate with their allocated intervention (i.e. high-intensity, moderate-intensity).
Intervention code [1] 319546 0
Prevention
Intervention code [2] 319547 0
Lifestyle
Intervention code [3] 319548 0
Behaviour
Comparator / control treatment
Stretching and usual-care group: Individuals allocated to the Stretching group will undertake a supervised stretching intervention for three months, three times per week for 50 minutes. These sessions will be conducted by an accredit exercise physiologist or physiotherapist. The classes will be conducted in groups of 3-5 participants, and will include stretching of major muscle groups and balance exercises. Attendance records and completion of sessions will be kept to monitor adherence.
In the 9 months following the 3 months of stretching, participants will be provided with usual-care (i.e., recommendations to exercise). The stretching group will not participate in any education sessions.
Control group
Active

Outcomes
Primary outcome [1] 326284 0
Feasibility, defined by adherence to the intervention during the supervised (0-3 months) intervention block, recruitment time and costs, attrition, and adverse events.
This will be measured by analysis of the study database, specifically examining data collection on session attendance (adherence), the budget (costs spent on recruitment and delivery of project), study withdrawals and adverse events. These will be assessed by audit of the study-specific database.
Timepoint [1] 326284 0
3 months post-commencement of intervention
Primary outcome [2] 327578 0
Feasibility, defined by adherence to the intervention during the unsupervised (3-12 months) intervention block, attrition, and adverse events.
This will be measured by analysis of the study database, specifically examining data collection on session attendance (adherence), the budget (costs spent on recruitment and delivery of project), study withdrawals and adverse events. These will be assessed by audit of the study-specific database.
Timepoint [2] 327578 0
12 months post-commencement of intervention
Secondary outcome [1] 390895 0
Change in Fitness, measured by the six-minute walk test
Timepoint [1] 390895 0
Measured by change from baseline to 3 and 12 months post-intervention
Secondary outcome [2] 390898 0
Cognitive function, defined by a composite score from a range of cognitive tasks assessing various cognitive domains. A comprehensive battery of neuropsychological tests will be administered at baseline and 12 months. Participants will undertake the Montreal Cognitive Assessment (MoCA), Memory Assessment Clinic-Questionnaire (MAC-Q), California Verbal Learning Test (CVLT-II), Visual reproduction test I and II, Digit Span (WAIS-IV), Trail Making test forms A and B, verbal fluency and switching (DKEFS), Colour-Word Interference and Switching (DKEFS), and flanker and set-shifting .
A shorter battery of tests (alternate forms and/or low practice effects) will be completed immediately post the Supervised Exercise (3 months), and will include: MoCA, CVLT-II, Visual Reproduction tests, and MAC-Q.
Timepoint [2] 390898 0
Measured by change from baseline to 3 and 12 months post-intervention
Secondary outcome [3] 390902 0
Subjective change in cognitive ability, as defined by scores on the memory complaint questionnaire (MAC-Q)
Timepoint [3] 390902 0
Measured by change from baseline to 3 and 12 months post-intervention

Eligibility
Key inclusion criteria
- 65-85 years of age
- Cognitively normal (normal performance on objective cognitive tests)
- Subjective cognitive decline (defined by subjective reports of memory complaints)
- Not meeting physical activity guidelines of 150 minutes of moderate-intensity exercise per week or 90 minutes of vigorous-intensity activity per week
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Outside ages 65 to 85
• Non-English speaker
• Physical impairments limiting ability to participate in either resistance or aerobic exercise (particularly cycle-based exercise)
• Dementia/cognitive decline
• Schizophrenia or bipolar disorder
• Uncontrolled depression
• Untreated sleep apnoea
• Alcohol or drug abuse
• Serious head injury
• Cancer within 5 years (excluding basal cell skin cancers)
• Uncontrolled hypertension or diabetes mellitus
• Other significant untreated illness
• Participating in over 150 minutes of moderate intensity exercise p/w or greater than 90 minutes of vigorous intensity activity p/w

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be conducted off-site by a researcher not working directly on this project or having contact with participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation accounting for gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics and group comparisons (i.e. using independent sample t-tests and chi-square) will be used to describe the feasibility of the study. Analysis of variance will be used to determine differences in changes in cognition, fitness and subjective cognitive decline symptoms from pre- (baseline) to mid- (3 months) to post-intervention (12 months).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 32813 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 307651 0
Charities/Societies/Foundations
Name [1] 307651 0
Dementia Australia Research Foundation/Dementia Collaborative Research Centre
Country [1] 307651 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street,
Murdoch,
Western Australia, 6150
Country
Australia
Secondary sponsor category [1] 308347 0
None
Name [1] 308347 0
Address [1] 308347 0
Country [1] 308347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307689 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 307689 0
Ethics committee country [1] 307689 0
Australia
Date submitted for ethics approval [1] 307689 0
17/03/2020
Approval date [1] 307689 0
20/05/2020
Ethics approval number [1] 307689 0
2020/038

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

Contacts
Principal investigator
Name 108150 0
A/Prof Belinda Brown
Address 108150 0
Murdoch University
90 South Street,
Murdoch,
Western Australia 6150
Country 108150 0
Australia
Phone 108150 0
+61 8 93609163
Fax 108150 0
Email 108150 0
[email protected]
Contact person for public queries
Name 108151 0
Belinda Brown
Address 108151 0
Murdoch University
90 South Street,
Murdoch,
Western Australia 6150
Country 108151 0
Australia
Phone 108151 0
+61 8 93609163
Fax 108151 0
Email 108151 0
[email protected]
Contact person for scientific queries
Name 108152 0
Belinda Brown
Address 108152 0
Murdoch University
90 South Street,
Murdoch,
Western Australia 6150
Country 108152 0
Australia
Phone 108152 0
+61 8 93609163
Fax 108152 0
Email 108152 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?
Raw data from outcome measures at all timepoints and randomisation.
When will data be available (start and end dates)?
Following completion of data collection and quality control (anticipated December 2022) for 5 years after publication
Available to whom?
Other researchers following an expression of interest submitted to the Principal Investigator.
Available for what types of analyses?
Available for analyses relating to cognitive ageing.
How or where can data be obtained?
Expressions of interest should be submitted to the Principal Investigator 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.