NCT02057354

Brief Summary

The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes, brain function, and the amount of several proteins in the blood. These proteins include a hormone called cortisol, also known as the "stress hormone," and a growth factor called "brain-derived neurotrophic factor" (BDNF). The "stress hormone" cortisol is produced by the adrenal glands. Stress, exercise, obesity, and other factors may influence cortisol levels. BDNF is a protein that promotes the health of nerve cells in the brain and in the body. It plays a role in the growth, maturation, and maintenance of these cells. The amount of this protein in blood samples is therefore an indicator of healthy nerve cell function. Here, the investigators are investigating if exercise improves brain function by changing BDNF levels. Participation in this research study will take approximately 4 months. During this time, participants will make four initial study visits. The first visit is for informed consent and screening, the second and third visits are for baseline fitness testing, and the fourth visit is for a blood draw, cognitive testing, and a functional Magnetic Resonance Imaging (fMRI) exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a given task. It will take up to approximately three weeks to complete these initial four study visits. Following the four initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: an aerobic exercise program and a non-aerobic exercise program consisting of strengthening, balance and stretching exercises. The exercise training program will last 12 weeks. There will be three one-hour exercise sessions per week. After completion of the exercise-training program, participants will attend three follow-up study visits. The first two follow-up visits are for fitness testing. The third and final follow-up visit is for a blood draw, cognitive testing, and an MRI exam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

February 5, 2014

Last Update Submit

April 23, 2018

Conditions

Keywords

BrainBrain-Derived Neurotrophic FactorBrain MappingCognitionExerciseHippocampusHydrocortisoneLearningMemoryMagnetic Resonance ImagingNerve Growth FactorsNeuroimagingPhysical EndurancePhysical FitnessResistance TrainingWalking

Outcome Measures

Primary Outcomes (3)

  • MRI

    Measurement of brain activity during task performance and measurement of change in regional brain volumes.

    1.5 to 2 hours each at Visits 4 and 43

  • Serum BDNF level

    Fasting blood draw on same day of MRI to measure change in serum BDNF from baseline to follow-up

    5 minutes each at Visits 4 and 43

  • Memory test performance

    Participants will perform recognition memory tests during and after functional MRI. Measurements include baseline-to-follow-up change in reaction times and accuracy.

    1.5 to 2 hours each at Visits 4 and 43

Secondary Outcomes (1)

  • Aerobic capacity and muscle strength

    80 min each at Visits 2, 3, 41 and 42

Other Outcomes (4)

  • Blood cortisol levels

    5 min each at Visits 4 and 43

  • Anthropometric measurements

    10 minutes each during Visits 2 and 41

  • Blood serum levels of other neurotrophins

    5 min each at Visit 4 and 43

  • +1 more other outcomes

Study Arms (2)

Healthy Sedentary Young Adults

ACTIVE COMPARATOR

Participants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.

Behavioral: Aerobic ExerciseBehavioral: Non-Aerobic Exercise

Healthy Sedentary Older Adults

EXPERIMENTAL

Participants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.

Behavioral: Aerobic ExerciseBehavioral: Non-Aerobic Exercise

Interventions

The goal of the aerobic exercise training is to increase aerobic endurance. Walking on treadmill at moderate intensity with grade adjusted. Exercise tailored to individual ability level.

Also known as: Endurance Training
Healthy Sedentary Older AdultsHealthy Sedentary Young Adults

The goal of this training is to improve overall muscle strength, balance and flexibility. Participants will do strength, balance and stretching exercises. Exercises tailored to individual ability level.

Also known as: Strength, balance, stretching
Healthy Sedentary Older AdultsHealthy Sedentary Young Adults

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking
  • Age between 18-35 years or between 55-85 years
  • Sedentary status (physically inactive)
  • Generally healthy
  • Native-English speaker

You may not qualify if:

  • Diagnosis of severe anemia
  • Past or present condition that affect cognitive functioning:
  • learning disability
  • neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.)
  • psychiatric disorders or conditions (depression, anxiety disorder, etc.)
  • Poor vision that cannot be corrected with glasses or contact lenses
  • Presence of an infection
  • Diagnosis of kidney failure
  • Diagnosis of liver disease
  • Diagnosis of thyrotoxicosis/hyperthyroidism
  • Diagnosis of cancer
  • Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise:
  • heart (e.g. heart attack, arrhythmias, etc.)
  • circulatory (e.g. uncontrolled hypertension, high cholesterol, etc.)
  • respiratory conditions (e.g., asthma or lung conditions, such as chronic obstructive pulmonary disease, acute bronchitis, acute common cold, lung cancer, pneumonia, etc.)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • Kern KL, Storer TW, Schon K. Cardiorespiratory fitness, hippocampal subfield volumes, and mnemonic discrimination task performance in aging. Hum Brain Mapp. 2021 Mar;42(4):871-892. doi: 10.1002/hbm.25259. Epub 2020 Dec 16.

  • Nauer RK, Dunne MF, Stern CE, Storer TW, Schon K. Improving fitness increases dentate gyrus/CA3 volume in the hippocampal head and enhances memory in young adults. Hippocampus. 2020 May;30(5):488-504. doi: 10.1002/hipo.23166. Epub 2019 Oct 7.

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseEndurance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Karin Schon, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor, Department of Anatomy & Neurobiology, BUSM

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations