Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000643370
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
3/05/2017
Date last updated
29/03/2022
Date data sharing statement initially provided
29/03/2022
Date results information initially provided
29/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of high-intensity exercise on cognitive function in healthy older adults
Scientific title
The influence of exercise intensity on the prevention of cognitive decline in older adults
Secondary ID [1] 291745 0
Nil
Universal Trial Number (UTN)
Trial acronym
IPAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 302956 0
Cognitive decline 302957 0
Condition category
Condition code
Neurological 302424 302424 0 0
Alzheimer's disease
Neurological 302431 302431 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to either low-intensity exercise or high-intensity exercise will complete 6 months of either a low-intensity or high-intensity cycling program consisting of two sessions (~50 minutes per session) per week. All exercise sessions will be completed within a university setting under the guidance of an Exercise Physiologist and other trained staff. The sessions will be completed on a cycle ergometer to allow accurate measurement of workload (Wattage), and radiotelemetric heart rate monitors (Polar 810i, Polar, Finland) will be used to monitor physiological effort.

The intensity of exercise will be determined using the Borg scale of perceived exertion. This method will alleviate the need to do multiple retests of fitness as individuals will increase effort to maintain perceived exertion with increasing fitness. Individuals in the high-intensity group will complete the six month intervention regimen, attending 2 sessions per week of ~50mins at Murdoch University exercise physiology laboratory. Each session will be comprised of 11 intervals of 1 minute of hard effort cycling (~80-90% aerobic capacity; 18.0 Borg scale) interspersed with 2 minutes of active recovery (30-40% aerobic capacity; 12 Borg scale) with an additional warm-up and cool-down period provided. Participants allocated to the low-intensity group will also complete a six month exercise regimen, attending 2 sessions per week of ~50 mins at Murdoch University exercise physiology laboratory. Each session will be comprised of constant intensity cycling (~50% aerobic capacity; 13.0 Borg scale) and, within their best ability, participants will be encouraged to complete the entire 50 minutes of cycling.
Intervention code [1] 297850 0
Lifestyle
Intervention code [2] 297851 0
Prevention
Comparator / control treatment
Individuals assigned to the control group will be provided with educational material (in the form of pamphlets designed for the purpose of this study) related to the benefits of diet and exercise with respect to Alzheimer’s disease; however, these individuals will not receive any exercise technique instruction.
Control group
Active

Outcomes
Primary outcome [1] 301827 0
A composite cognitive score calculated from test scores from validated neuropsychological tests. The neuropsychological tests used to comprise the composite score include: The California Verbal Learning Test, Brief Visual Memory Test, Verbal fluency, Trails B and Digit Span.
Timepoint [1] 301827 0
Post-intervention (6 months)
Secondary outcome [1] 333976 0
Brain volume measured using volumetric magnetic resonance imaging
Timepoint [1] 333976 0
Post-intervention (6 months)
Secondary outcome [2] 333977 0
Brain connectivity measured using functional magnetic resonance imaging
Timepoint [2] 333977 0
Post-intervention (6 months)
Secondary outcome [3] 334005 0
Blood biomarkers (these will be defined based on the most current evidence of biomarkers linked to AD pathology)
Timepoint [3] 334005 0
Post-intervention (6 months)
Secondary outcome [4] 334193 0
A composite cognitive score calculated from test scores from validated neuropsychological tests. The neuropsychological tests used to comprise the composite score include: The California Verbal Learning Test, Brief Visual Memory Test, Verbal fluency, Trails B and Digit Span.
Timepoint [4] 334193 0
12 months post-intervention (18 months from baseline)

Eligibility
Key inclusion criteria
Aged 60-80 years, cognitively healthy (i.e. no diagnosis of dementia), adequate visual and auditory acuity to complete neuropsychological testing, willingness to participate in entirety of study, willingness and ability to provide written informed consent, able to provide a letter from usual GP endorsing participants ability to partake in all aspects of the study.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A diagnosis of AD or another neurodegenerative disease, or a score of less than 26 on the Mini Mental State Examination.
2. Presence of clinical depression as measured by a score of 6 or greater on the Geriatric Depression Scale (GDS) Short Form.
3. Inability to undertake cycling-based exercise due to neuromuscular and/or musculo-skeletal limitations.
4. Inability to obtain medical clearance to participate in the exercise program.
5. Lifetime history of schizophrenia, shizoaffective disorder, or bipolar disorder
6. Subjects with untreated obstructive sleep apnoea
7. History of electroconvulsive therapy or serious head injury resulting in a prolonged period of unconsciousness.
8. History of alcohol abuse or dependence within 2 years of screening
9. Participants with a history of cancer (other than skin or in situ prostate cancer) within the previous 5 years
10. Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol including: history of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or Congestive Heart, chronic renal failure, chronic hepatic disease, severe pulmonary disease, epilepsy etc.
11. Insulin-requiring diabetes or uncontrolled diabetes mellitus
12. Uncontrolled hypertension (systolic BP greater than 170 or diastolic BP greater than 100)
13. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
5/12/2017
Date of last data collection
Anticipated
31/07/2019
Actual
25/09/2019
Sample size
Target
105
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296239 0
Government body
Name [1] 296239 0
NHMRC-ARC Dementia Research Development Fellowship
Country [1] 296239 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 295158 0
None
Name [1] 295158 0
Address [1] 295158 0
Country [1] 295158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297479 0
Murdoch University
Ethics committee address [1] 297479 0
90 South St, Murdoch WA 6150
Ethics committee country [1] 297479 0
Australia
Date submitted for ethics approval [1] 297479 0
Approval date [1] 297479 0
07/10/2016
Ethics approval number [1] 297479 0
Ethics committee name [2] 297480 0
Edith Cowan University
Ethics committee address [2] 297480 0
270 Joondalup Drive
Joondalup
Western Australia 6027
Ethics committee country [2] 297480 0
Australia
Date submitted for ethics approval [2] 297480 0
Approval date [2] 297480 0
31/03/2015
Ethics approval number [2] 297480 0

Summary
Brief summary
This study is designed to assess the impact of a six month high- and low-intensity cycle-based exercise intervention on cognitive function, measures of brain volume and connectivity and Alzheimer’s disease (AD)-related blood biomarkers in a cohort of older adults aged 60 - 80 years. Furthermore, we will assess the impact of genetic predisposition on responses to exercise within this population. The effect of the exercise regimen will be assessed using a comprehensive battery of neuropsychological tests to assess cognitive function. To assess the impact of the intervention on AD risk, MRI scans and measurements of blood biomarkers will also be evaluated across the intervention groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74178 0
Dr Belinda Brown
Address 74178 0
School of Psychology and Exercise Science
Murdoch University
90 South Street, Murdoch, Western Australia, 6150
Country 74178 0
Australia
Phone 74178 0
+ 618 9360 6193
Fax 74178 0
Email 74178 0
b.brown@murdoch.edu.au
Contact person for public queries
Name 74179 0
Mr Shaun Markovic
Address 74179 0
Australian Alzheimer's Research Centre
Building 11, Hollywood Private Hospital
115 Monash Avenue
Nedlands, Western Australia, 6009
Country 74179 0
Australia
Phone 74179 0
+61862986308
Fax 74179 0
Email 74179 0
s.markovic@ecu.edu.au
Contact person for scientific queries
Name 74180 0
Dr Belinda Brown
Address 74180 0
School of Psychology and Exercise Science
Murdoch University
90 South Street, Murdoch, Western Australia, 6150
Country 74180 0
Australia
Phone 74180 0
+61893606193
Fax 74180 0
Email 74180 0
b.brown@murdoch.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individuals participant data for cognition, fitness and MRI outcomes. As well as descriptive/demographic data in the cohort.
When will data be available (start and end dates)?
01/01/2022 to 31/12/2024
Available to whom?
Researchers that apply directly to b.brown@murdoch.edu.au
Available for what types of analyses?
Any analysis examining the role of exercise in maintaining health in older adulthood.
How or where can data be obtained?
Please contact Belinda Brown on b.brown@murdoch.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15606Study protocolBrown, B. M., Rainey-Smith, S. R., Castalanelli, N., Gordon, N., Markovic, S., Sohrabi, H. R., ... & Peiffer, J. J. (2017). Study protocol of the Intense Physical Activity and Cognition study: The effect of high-intensity exercise training on cognitive function in older adults. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 3(4), 562-570. b.brown@murdoch.edu.au



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Brown, B. M., Frost, N., Rainey-Smith, S. R., Doec... [More Details]
Study results articleYes Frost, N. J., Weinborn, M., Gignac, G. E., Rainey-... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh-intensity exercise and cognitive function in cognitively normal older adults: a pilot randomised clinical trial.2021https://dx.doi.org/10.1186/s13195-021-00774-y
EmbaseStudy protocol of the Intense Physical Activity and Cognition study: The effect of high-intensity exercise training on cognitive function in older adults.2017https://dx.doi.org/10.1016/j.trci.2017.09.003
Dimensions AIThe impact of exercise on blood-based biomarkers of Alzheimer’s disease in cognitively unimpaired older adults2024https://doi.org/10.1007/s11357-024-01130-2
N.B. These documents automatically identified may not have been verified by the study sponsor.