The Effects of Exercise on Sleep and Brain Health

NCT04210882 | Completed

• 1 other identifier: 2019P000673
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Brain health and cognitive functioning can be affected by aging. Exercise is a potentially effective method for promoting "successful brain aging" by improving cardiovascular fitness, brain function and possibly sleep quality. This project will measure the effects of exercise on brain health and attempt to develop a better way to track brain health, by measuring brain activity during sleep.

Conditions

Aging; Sleep Disorder

Keywords

Cardiovascular; Neuroscience; Exercise

Outcome Measures

Primary Outcomes (2)

• Change from baseline in EEG-based Brain Age (as measured via the Brain Age Index algorithm) after a 12-week aerobic exercise program.

  The Brain Age Index (BAI) algorithm reports how old an individual's sleeping brain activity "looks", called the "brain age" (BA), and compares this with the chronological age (CA). The difference is the Brain Age Index (BAI), which is calculated by subtracting the Chronological Age (CA) from the calculated Brain Age (BA): BAI = BA-CA. A higher BAI can reflect worse clinical outcomes (e.g. increase mortality risk) while a lower BAI can reflect better clinical outcomes.

  Baseline, 12 weeks

• Change from baseline in cognitive performance (as measured via the National Institutes of Health (NIH) Toolbox Cognition battery) after a 12-week aerobic exercise program.

  The NIH Toolbox Cognition battery is a composite of 7 tests \[Picture Vocabulary (PV), Reading Test (RT), Flanker, Dimensional Change Card Sort (DCCS), Picture Sequence Memory (PSM), List Sorting (LS), Pattern Comparison (PC)\] assessing language, receptive vocabulary, executive function, attention, working/short-term/episodic memory, cognitive flexibility, processing speed, prior education, verbal intelligence. Uncorrected, Age-corrected, and Fully-Corrected scores (mean =100,100,50 and StdDev=15,15,10 respectively) are calculated for each test. Composite scores are given for Fluid, Crystallized, and overall Cognitive Function. The Fluid Composite Score is derived by averaging the std. scores of the Flanker, DCCS, PSM, LS and PC tests. The Crystallized Composite Score is derived by averaging the std. scores of the PV \& RT. The Cognitive Function Composite Score is derived by averaging the Fluid \& Crystallized std. scores. Higher scores indicate higher levels of cognitive functioning.

  Baseline, 12 weeks

Secondary Outcomes (9)

• Association between brain age index (BAI) and sleep quality (as measured via a home sleep EEG monitoring device).

  Weeks 1-12

• Association between brain age index (BAI) and sleep quality (as measured via respiration).

  Weeks 1-12

• Association between brain age index (BAI) and pre-existing co-morbidity (as measured via the Charlson Co-morbidity Index).

  Baseline

• Association between brain age index (BAI) and depression (as measured via the Patient Health Questionnaire-2).

  Baseline

• Association between brain age index (BAI) and anxiety (as measured via the Generalized Anxiety Disorder Questionnaire-2).

  Baseline

Study Arms (1)

12-week Moderate-Intensity Exercise Program

EXPERIMENTAL

Exercise intervention: Participants will complete 57 total sessions of moderate-intensity exercise (walking while tracking heart rate) over 12 weeks. Exercise intensity, frequency, and session duration will increase during the first 4 weeks of the intervention until participants are completing five (5) sessions weekly and walking for 30 min each session at 60-75% of Heart Rate Reserve (HRR) (moderate-intensity exercise), as follows: Week 1: Three sessions, lasting ≥ 15 minutes, at 50-75% of HRR; Week 2: Four sessions, lasting ≥ 20 minutes, at 50-75% of HRR; Week 3: Five sessions, lasting ≥ 30 minutes, at 50-75% of HRR; Weeks 4-12: Five sessions, lasting ≥ 30 minutes, at 60-75% of HRR

Behavioral: Moderate-Intensity Exercise

Interventions

Moderate-Intensity Exercise BEHAVIORAL

See description of study arm.

12-week Moderate-Intensity Exercise Program

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedentary (≤ two exercise sessions per week for the past 6 months)
• Aged 50 to 75 years old
• Cleared by primary care physician or other personal physician to participate in a 12-week moderate-intensity walking exercise program. Clearance can be provided to one of the study investigators either verbally or in writing.

You may not qualify if:

• History of neurological illness (e.g. poorly controlled epilepsy with \>1 seizure per month in the last 6mo, stroke with residual motor language deficits, Multiple sclerosis, Parkinson's disease, clinically diagnosed dementia \[defined as score \<26 on the Mini-Mental State Examination\], head trauma in the preceding 6-months with continued cognitive symptoms, cerebral palsy, brain tumor, normal-pressure hydrocephalus, HIV infection, or Huntington's disease)
• Untreated Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorders (i.e., severe depressive symptoms, substance abuse or dependence)
• Impaired activities of daily living (ADLs) measured by the Lawton and Brody Self-Maintaining and Instrumental Activities of Daily Living Scale.
• Inability to safely exercise or perform any of the tests
• Inability to perform the cognitive tests due to lack of English proficiency
• Known diagnosis of severe sleep apnea (apnea-hypopnea index ≥ 15/hour of sleep)
• Subject fails Cardiopulmonary Exercise Testing (CPET), i.e. develops symptoms such as shortness of breath, chest pain, palpitations, lightheadedness, or syncope during CPET testing
• Patients with a pacemaker or an automatic implantable cardioverter-defibrillator.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• M. Brandon Westover, MD/PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Harvard Medical School & Principal Investigator

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 26, 2019
• Study Start: October 31, 2019
• Primary Completion: August 4, 2021
• Study Completion: August 4, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)