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Exercise Training for Mild Cognitive Impairment

N/A

Waitlist Available

Led By Alexander MacKay, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a baseline Montreal Cognitive Assessment (MoCA) score < 26/30

Able to walk independently

Must not have

Diagnosed with dementia of any type

At high risk for cardiac complications during exercise or unable to self-regulate activity or to understand recommended activity level

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of AT, RT, and a combination of both on cognitive function in older adults with mild cognitive impairment.

Who is the study for?

This trial is for older adults in Metro Vancouver with mild cognitive impairment, who have a MMSE score of 22 or higher and MoCA score below 26. They should be able to walk, follow the trial's plan, and not be on certain dementia medications. People already doing moderate exercise, diagnosed with dementia other than AD or VCI, at high cardiac risk during exercise, or on cognition-impairing drugs can't join.

What is being tested?

The study tests how different types of exercises affect brain function in those with mild cognitive impairment. It compares aerobic training (like running), resistance training (like lifting weights), and balance/tone training to see which is best for improving memory and thinking skills.

What are the potential side effects?

Exercise programs generally carry risks like muscle strain or injury from physical activity. Specific side effects will depend on the individual's health condition but are typically low when exercises are done correctly under supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cognitive test score is below 26 out of 30.

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I can walk on my own without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a type of dementia.

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I am at high risk for heart problems during exercise or can't manage my activity level.

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I am not on medications that could worsen my thinking or memory.

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I have not taken hormone therapy in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)

Secondary study objectives

ADAS-Cog Plus

Body composition as measured by DXA

Brain function as measured by functional magnetic resonance imaging (fMRI)

+47 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Resistance Training (RT)Experimental Treatment2 Interventions

The RT program will be a four-times-per week program. Twice a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.

Group II: Aerobic Training and Resistance Training (A&RT)Experimental Treatment2 Interventions

The A\&RT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form.

Group III: Aerobic Training (AT)Experimental Treatment2 Interventions

The AT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.

Group IV: Balance and Tone Program (CON)Active Control1 Intervention

The CON program will be a four-times-per week program. The CON group will consist of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Training

2024

N/A

~880

Resistance Training

2019

Completed Phase 2

~1230