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Regular Exercise for Aging Brain Health (BIM Trial)

N/A

Recruiting

Led By Marc J Poulin, PhD, DPhil

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Ability to walk independently outside or on stairs

Be older than 18 years old

Must not have

Known asthma or sleep apnea

History of arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the effects of physical activity on the brain. It will test if exercise can help maintain brain function as we age.

Who is the study for?

This trial is for men and women aged 55 or older who are generally inactive, with a BMI under 35, can walk independently, and have not had major surgery or trauma in the past 6 months. Women must be postmenopausal for at least a year. People with recent heart issues, stroke, chronic headaches, blood clots, smokers within the last year or those on certain medications like beta-blockers cannot participate.

What is being tested?

The study tests if regular aerobic exercise improves brain blood flow (cerebrovascular reserve) and mental functions in older adults. It includes an initial assessment period followed by six months of guided aerobic training based on established guidelines and cognitive testing before concluding with follow-up assessments over several years.

What are the potential side effects?

Aerobic exercise is typically safe but may include muscle soreness, fatigue, falls risk for those with balance issues; however serious side effects are rare especially when activities are tailored to individual fitness levels as per this study's design.

Eligibility Criteria

Inclusion Criteria

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

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I can walk by myself outside or on stairs.

Exclusion Criteria

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

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I have asthma or sleep apnea.

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I have a history of irregular heartbeats.

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I have had a heart attack before.

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I have had heart valve disease.

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I have a history of chronic heart failure.

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I experience chest pain when I exert myself physically.

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I have a history of blood clots.

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I am currently taking medication such as beta-blockers, anti-depressants, or blood thinners.

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I have had a stroke in the past.

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I have a history of heart or stroke-related issues.

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I have a history of chronic headaches or migraines.

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I have a history of chest pain due to heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline (0 and 6 months), during the exercise intervention (9 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in Risk/protective factors Assessed by Questionnaires

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aerobic exerciseExperimental Treatment1 Intervention

Participants took part in a supervised 6-month long aerobic (walk/jog) training program held 3 days/week. Each session included a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cooldown, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise increased from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity is based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity builds from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic exercise

2000

Completed Phase 2

~1130

0 / 13Eligibility criteria met