The Effects of Exercise on Synaptic Plasticity in Individuals With Mild Cognitive Impairment and in Healthy Aging.
1 other identifier
interventional
36
1 country
6
Brief Summary
The research is focused on ameliorating cognitive decline in aging and in individuals diagnosed with Mild Cognitive Impairment (MCI). In the proposed research, we ask whether synaptic plasticity is modified by exercise in these groups and if these changes relate to improved cognition. We know that cognition improves with exercise, but if we discover that synaptic plasticity is indeed modified by exercise, this opens many possibilities for us to explore new approaches to change synaptic plasticity in these populations. We view this project as benefiting all aging individuals, with or without MCI, since we are working to improve cognition. Understanding the mechanisms will help design better therapeutic strategies for older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedStudy Start
First participant enrolled
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedMarch 16, 2023
March 1, 2023
1.9 years
November 10, 2022
March 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline Synaptic Plasticity at 4 weeks
To assess synaptic plasticity, repetitive TMS will be performed using two methods. Intermittent theta burst stimulation (iTBS) protocol will be delivered using biphasic pulses in burst of three pulses delivered at 30Hz, in 6Hz trains that will last 2s, this will be followed by 8s with no pulse delivered. iTBS will be repeated for a total of 612 pulses at 80% of active motor threshold.The average of twenty single-pulse motor evoked potentials (MEPs) will be recorded following iTBS. In the second protocol participants will receive approximately 10 trains of 10 stimuli at a frequency of 5Hz. The stimulation intensity will be set to 120% of rMT with an inter-train interval of 2 minutes. MEPs will be recorded during the first and tenth bout of a 5Hz rTMS protocol.
1-7 days prior to intervention , 1-7 days post intervention
Secondary Outcomes (4)
Change from Baseline Cognitive function at 4 weeks
1-7 days prior to intervention , 1-7 days post intervention
Change from Baseline Brain Derived Neurotropic Factor at 4 weeks
1-7 days prior to intervention , 1-7 days post intervention
Participant experience
1-7 days post intervention
Change from Baseline Osteocalcin at 4 weeks
1-7 days prior to intervention , 1-7 days post intervention
Study Arms (3)
Exercise Training in Individuals with Mild Cognitive Impairment
ACTIVE COMPARATORIndividuals will participate in 3 sessions of Self Determined Intensity Interval training per week for 4 weeks, using a stationary bike at an intensity whereby their Ratings of Perceived exertion (RPE) is challenging. RPE will be measured using a Borg's 6-20 scale. (44). The cycling protocol will include a 3-minute warm-up, five, 1-minute cycling intervals, interspersed with 1.5 minutes of recovery. and a 2-minute cool-down. The RPE will be acquired by asking the participant to provide their rating at the end of the last interval.
Individuals with Mild Cognitive Impairment and No exercise
NO INTERVENTIONGroup B: Participants in this arm will not experience any intervention during a 4 week period of time.
Exercise Training in age and sex matched healthy controls
ACTIVE COMPARATORIndividuals will participate in 3 sessions of Self Determined Intensity Interval training per week for 4 weeks, using a stationary bike at an intensity whereby their Ratings of Perceived exertion (RPE) is challenging. RPE will be measured using a Borg's 6-20 scale. (44). The cycling protocol will include a 3-minute warm-up, five, 1-minute cycling intervals, interspersed with 1.5 minutes of recovery. and a 2-minute cool-down. The RPE will be acquired by asking the participant to provide their rating at the end of the last interval.
Interventions
Individuals will participate in 3 sessions of Self Determined Intensity Interval training, using a cycle ergometer, for 4 weeks.Ratings of Perceived exertion (RPE) will be measured using a Borg's 6-20 scale. (44). Users will be asked to exercise on a stationary bike at an intensity whereby there RPE is challenging. The cycling protocol includes five, 1-minute cycling intervals, interspersed with 1.5 minutes of recovery (cycling at a slow pace to bring the individuals heart rate down). Participants will also perform a 3-minute warm-up and a 2-minute cool-down for a total exercise duration of 17.5 minutes
Eligibility Criteria
You may qualify if:
- Individuals must have a diagnosis of mild cognitive impairment in order to be assigned to Group A or Group B
You may not qualify if:
- Contradictions to receiving repetitive transcranial magnetic stimulation.
- Contradictions to performing physical exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- McMaster Institute for Research in Agingcollaborator
- Canada Research Chaircollaborator
Study Sites (6)
St. Joseph's Healthcare Hamilton, King Campus
Hamilton, Ontario, L8G5E4, Canada
St. Joseph's Hospital- St. Peter's Clinic
Hamilton, Ontario, L8M 1W9, Canada
St. Joseph's Healthcare's Charlton Campus
Hamilton, Ontario, L8N 4A6, Canada
McMaster Family Practice
Hamilton, Ontario, L8P 1H6, Canada
McMaster Unviersity
Hamilton, Ontario, L8S 4K1, Canada
Stonechurch Family Practice
Hamilton, Ontario, L8W 3J6, Canada
Related Publications (1)
Ramdeo KR, Fahnestock M, Gibala M, Selvaganapathy PR, Lee J, Nelson AJ. The Effects of Exercise on Synaptic Plasticity in Individuals With Mild Cognitive Impairment: Protocol for a Pilot Intervention Study. JMIR Res Protoc. 2023 Oct 18;12:e50030. doi: 10.2196/50030.
PMID: 37851488DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor will be unaware of the allocation of participants to specific groups because the data will be anonymized.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Aimee Nelson
Study Record Dates
First Submitted
November 10, 2022
First Posted
December 23, 2022
Study Start
February 13, 2023
Primary Completion
January 1, 2025
Study Completion
May 1, 2025
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share