NCT03158337

Brief Summary

While it is well established that physical inactivity is a modifiable risk factor for vascular disease and cognitive decline, the mechanism by which exercise exerts its protective effect on the cerebral circulation and cognition is unknown. This knowledge gap was recognized recently in the Centers for Disease Control \& Prevention and the Alzheimer's Association document "National Public Health Road Map to Maintaining Cognitive Health". Our rationale for these studies is that the identification of physical exercise as a lifestyle factor able to improve cerebrovascular reserve and cognition would establish a strong scientific framework justifying design of a randomized clinical trial that could evaluate the role of physical activity in cerebrovascular health and function. This research is based on data we obtained from a cross-sectional study that showed significant relations between physical fitness, vascular regulation and cognition. Cerebrovascular reserve and cognition were better maintained in women who were physically active but reduced in women who were sedentary. Our central hypothesis is that regular aerobic exercise mitigates age-related decreases in cerebrovascular reserve, which in turn imparts benefits in cognition. Further, we believe that these effects will persist after the structured aerobic exercise program is terminated. Our 18 month study began with a 6-month baseline period, followed by a 6-month exercise intervention, and a 6-month follow-up period. In addition, there are 5-year and 10-year follow-up periods. Volunteers (men and women aged ≥ 55 years) from the community were recruited using a variety of recruitment methods including media and distribution lists. After the baseline (pre-training) measurements, participants underwent a six-month aerobic training program, following guidelines previously used by us and according to the new exercise guidelines for older adults established by American College of Sports Medicine and the American Heart Association. The study involves comprehensive assessments of physical fitness, cerebrovascular responses to carbon dioxide at rest and during sub-maximal exercise, and an extensive battery of cognitive function tests.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

May 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

6 years

First QC Date

May 16, 2017

Last Update Submit

November 2, 2022

Conditions

Keywords

ExercisePhysical ActivityBrain blood flowCognitionFitness

Outcome Measures

Primary Outcomes (1)

  • Change in Cognition Assessed by Neuropsychological Test Battery

    Measured at baseline (0 and 6 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months)

Secondary Outcomes (4)

  • Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart

    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)

  • Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound

    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)

  • Change in Blood Biomarkers Assessed by Elisa Assays

    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)

  • Change in Risk/protective factors Assessed by Questionnaires

    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)

Other Outcomes (2)

  • Change in Sleep Quality Assessed by Polysomnography, Actigraphy and Questionnaires

    A sub-sample of participants were assessed at baseline (6 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months).

  • Change in Brain Structure and Function Assessed by Neuroimaging Modalities

    A sub-sample of participants were assessed at baseline (6 months), exercise intervention completion (12 months) and follow up (18,72 and 132 months).

Study Arms (1)

Aerobic exercise

EXPERIMENTAL

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).

Behavioral: Aerobic exercise

Interventions

Aerobic exercise

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sedentary status (engages in less than 30 minutes of moderate exercise four days per week or 20 continuous minutes of vigorous exercise two days per week), the ability to walk independently outside or on stairs, body mass index (BMI) \< 35 kg/m\^2, women were at least 12 months postmenopausal on entry into the study

You may not qualify if:

  • heart/chest pain upon physical exertion, fainting spells/dizziness, surgery or major trauma in the previous 6 months, known asthma or sleep apnea, history of myocardial infarction, angina, arrhythmia, valve disease, chronic heart failure, history of stroke, cardiovascular or cerebrovascular disease, history of chronic headache or migraines, history of blood clots/thrombosis, smokers (within last 12 months), currently taking medication (beta-blockers, anti-depressants, digitalis/digoxin, blood thinners (warfarin), evista (raloxifene), corticosteroids (e.g., prednisone), adrenaline/epinephrine, anti-arrhythmics (e.g., norpace)).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Publications (6)

  • Tyndall AV, Davenport MH, Wilson BJ, Burek GM, Arsenault-Lapierre G, Haley E, Eskes GA, Friedenreich CM, Hill MD, Hogan DB, Longman RS, Anderson TJ, Leigh R, Smith EE, Poulin MJ. The brain-in-motion study: effect of a 6-month aerobic exercise intervention on cerebrovascular regulation and cognitive function in older adults. BMC Geriatr. 2013 Feb 28;13:21. doi: 10.1186/1471-2318-13-21.

    PMID: 23448504BACKGROUND
  • Pannu T, Sharkey S, Burek G, Cretu D, Hill MD, Hogan DB, Poulin MJ. Medication use by middle-aged and older participants of an exercise study: results from the Brain in Motion study. BMC Complement Altern Med. 2017 Feb 10;17(1):105. doi: 10.1186/s12906-017-1595-5.

  • Gill SJ, Friedenreich CM, Sajobi TT, Longman RS, Drogos LL, Davenport MH, Tyndall AV, Eskes GA, Hogan DB, Hill MD, Parboosingh JS, Wilson BJ, Poulin MJ. Association between Lifetime Physical Activity and Cognitive Functioning in Middle-Aged and Older Community Dwelling Adults: Results from the Brain in Motion Study. J Int Neuropsychol Soc. 2015 Nov;21(10):816-30. doi: 10.1017/S1355617715000880.

  • Tyndall AV, Argourd L, Sajobi TT, Davenport MH, Forbes SC, Gill SJ, Parboosingh JS, Anderson TJ, Wilson BJ, Smith EE, Hogan DB, Hill MD, Poulin MJ. Cardiometabolic risk factors predict cerebrovascular health in older adults: results from the Brain in Motion study. Physiol Rep. 2016 Apr;4(8):e12733. doi: 10.14814/phy2.12733.

  • Ishigami Y, Eskes GA, Tyndall AV, Longman RS, Drogos LL, Poulin MJ. The Attention Network Test-Interaction (ANT-I): reliability and validity in healthy older adults. Exp Brain Res. 2016 Mar;234(3):815-27. doi: 10.1007/s00221-015-4493-4. Epub 2015 Dec 8.

  • Drogos LL, Gill SJ, Tyndall AV, Raneri JK, Parboosingh JS, Naef A, Guild KD, Eskes G, Hanly PJ, Poulin MJ. Evidence of association between sleep quality and APOE epsilon4 in healthy older adults: A pilot study. Neurology. 2016 Oct 25;87(17):1836-1842. doi: 10.1212/WNL.0000000000003255.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marc J Poulin, PhD, DPhil

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc J Poulin, PhD, DPhil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

May 1, 2010

Primary Completion

May 5, 2016

Study Completion

May 1, 2026

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations