Study Summary
This trial is designed to investigate the effect of different types of exercise on the neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.
Eligible Conditions
- Aging
- Cardiovascular Risk
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Baseline and post-intervention at 12 months
Baseline
Baseline level of physical activity
Change in self-reported physical activity
Cognitive Reserve
Genetic biomarkers
Self-reported masculinity and femininity trait
Month 12
Change in gut microbiome
Month 12
Change in Balance performance
Change in Dietary patterns
Change in anxiety
Change in apolipoprotein B (ApoB)
Change in brain structure
Change in cardiorespiratory fitness
Change in central artery stiffness
Change in cerebral activity
Change in cerebral autoregulation - frontal cortical region
Change in cerebral autoregulation - middle cerebral arteries
Change in cerebral pulsatility - cortical frontal region
Change in cerebral pulsatility - middle cerebral arteries
Change in cerebral vasoreactivity - middle cerebral arteries
Change in cerebral vasoreactivity - prefrontal cortex
Change in cerebral vasoreactivity - whole brain
Change in chloride
Change in cholesterol non-HDL
Change in cholesterol-HDL
Change in cholesterol-LDL calculated
Change in chronic stress levels
Change in creatinine
Change in depressive symptoms
Change in episodic memory
Change in executive functions
Change in functional mobility
Change in general cognitive functioning
Change in glucose
Change in glycated hemoglobin (HbA1c)
Change in health related quality-of-life
Change in high-sensitive C-reactive protein (hsCRP)
Change in insulin
Change in lower limb muscles strength
Change in perceived stress
Change in peripheral endothelial function
Change in potassium
Change in processing speed
Change in sleep quality
Change in social and community activities involvement
Change in sodium
Change in total cholesterol
Change in transcriptomics
Body Weight Changes
Change in upper limb muscle strength
Change in walking speed
Change of neurotrophic biomarkers
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
3 Treatment Groups
Active control intervention
1 of 3
Multidomain intervention
1 of 3
Physical exercise intervention
1 of 3
Active Control
Experimental Treatment
318 Total Participants · 3 Treatment Groups
Primary Treatment: Aerobic and resistance exercises · No Placebo Group · N/A
Multidomain interventionExperimental Group · 2 Interventions: Aerobic and resistance exercises, Cognitive Training · Intervention Types: Other, Other
Physical exercise intervention
Other
Experimental Group · 1 Intervention: Aerobic and resistance exercises · Intervention Types: OtherActive control intervention
Other
ActiveComparator Group · 1 Intervention: Stretching and Toning · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and post-intervention at 12 months
Who is running the clinical trial?
Louis BhererLead Sponsor
4 Previous Clinical Trials
227 Total Patients Enrolled
2 Trials studying Aging
133 Patients Enrolled for Aging
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,268 Previous Clinical Trials
25,600,873 Total Patients Enrolled
11 Trials studying Aging
4,293 Patients Enrolled for Aging
The Montreal Health Innovations Coordinating Center (MHICC)OTHER
11 Previous Clinical Trials
8,828 Total Patients Enrolled
1 Trials studying Aging
216 Patients Enrolled for Aging
Louis Bherer, PhDPrincipal InvestigatorMontreal Heart Institute
8 Previous Clinical Trials
623 Total Patients Enrolled
3 Trials studying Aging
349 Patients Enrolled for Aging
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are not physically active for at least 150 minutes per week.
You have good eyesight and hearing for your age.
References
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- Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
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- Louis Bherer 2021. "A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04962061.
Frequently Asked Questions
How many participants are contributing to this research project?
"Affirmative. Clinicaltrials.gov documents the fact that this research project, which was first listed on September 1st 2021, is still enrolling patients. The total count of participants sought after stands at 318 from a single site." - Anonymous Online Contributor
Unverified Answer
What are the desired outcomes of this trial?
"This experiment's primary goal is to gauge changes in executive functions over the course of 12 months. In addition, secondary objectives include measuring Cerebral VasoReactivity (CVR) using TCD and NIRS on middle cerebral arteries and prefrontal cortex respectively as well as Pulsatility with NIRS applied to the prefrontal cortical region." - Anonymous Online Contributor
Unverified Answer
Are there any unfilled slots available in this research project?
"Affirmative. As indicated by the clinicaltrials.gov data, this clinical trial is currently accepting participants. This trial was first posted on September 1st 2021 and has most recently been updated on September 29th 2021; 318 individuals need to be recruited from one medical centre." - Anonymous Online Contributor
Unverified Answer