Recruiting

Exercise

Sponsor:

McMaster University

Code:

NCT05663918

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Interventions

Self- determined Intensity Interval Training

Study Details

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.

Conditions

Mild Cognitive Impairment

Study ID

NCT05663918

Start date

Feb 13, 2023

Status verified date

Mar, 2023

Completion date

May 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals must have a diagnosis of mild cognitive impairment in order to be assigned to Group A or Group B

Exclusion Criteria:

  • Contradictions to receiving repetitive transcranial magnetic stimulation.
  • Contradictions to performing physical exercise

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Exercise Training in Individuals with Mild Cognitive Impairment

Individuals 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.

no intervention: Individuals with Mild Cognitive Impairment and No exercise

Group B: Participants in this arm will not experience any intervention during a 4 week period of time.

active comparator: Exercise Training in age and sex matched healthy controls

Individuals 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

Self- determined Intensity Interval Training

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

Primary outcome measure

  • Change from Baseline Synaptic Plasticity at 4 weeks [ Time Frame: 1-7 days prior to intervention , 1-7 days post intervention ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton, King Campus

Recruiting

Hamilton, Ontario, Canada, L8G5E4

Contacts

Justin Lee, MD

(905) 521-2100

St. Joseph's Hospital- St. Peter's Clinic

Recruiting

Hamilton, Ontario, Canada, L8M 1W9

St. Joseph's Healthcare's Charlton Campus

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

McMaster Family Practice

Recruiting

Hamilton, Ontario, Canada, L8P 1H6

Contacts

Jill Berridge

905 525 9140

McMaster Unviersity

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Stonechurch Family Practice

Recruiting

Hamilton, Ontario, Canada, L8W 3J6

Contacts

Barb Flaherty

905.575.1744

More Information

Sponsor

McMaster University

Last update posted

Mar 16, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-03-16.