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AgingEMFNCT02057354

Neuroimaging Study of Exercise and Memory Function

A study testing Aerobic Exercise and Non-Aerobic Exercise in people with Aging, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Aerobic Exercise and Non-Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
1 siteUnited States
Study dates
Apr 2014to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 29Show fewer
  • 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.)
  • current musculoskeletal impairments (e.g. leg claudication, fractures, hemiplegia, chronic joint pain, arthritis, osteoporosis, not able to walk comfortably without assistance, etc.)
  • diagnosis of electrolyte disorder or abnormality
  • presence of diabetes mellitus
  • Claustrophobia (fear of small, encloses spaces)
  • Female subjects: breast-feeding or potentially pregnant
  • Obesity
  • Eating disorder
  • Compulsive exercising
  • Ferro-magnetic metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, permanent tattoo or eyeliner with metallic specks)
  • Prescription medication or other drugs that are cardio-active
  • Prescription medication or other drugs that are psycho-active
  • Drug abuse or alcohol misuse
  • Regularly exercising
  • Unavailable for the approximately 4-month duration of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Aerobic Exercise, Neurotrophins, and fMRI of Hippocampal Function and Structure

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.

Conditions
Aging
Being tested
Aerobic Exercise, Non-Aerobic Exercise
Keywords
Brain, Brain-Derived Neurotrophic Factor, Brain Mapping, Cognition, Exercise, Hippocampus, Hydrocortisone, Learning, Memory, Magnetic Resonance Imaging, Nerve Growth Factors, Neuroimaging, Physical Endurance, Physical Fitness, Resistance Training, Walking
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    Also called Endurance Training

    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.

  • Non-Aerobic ExerciseBehavioural

    Also called Strength, balance, stretching

    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.

Study groups in NCT02057354
Study groupRoleWhat they receive
Healthy Sedentary Young AdultsActive comparatorParticipants 18-35 years of age will be randomized to either aerobic or non-aerobic exercise training.
Receives: Behavioral: Aerobic Exercise; Behavioral: Non-Aerobic Exercise
Healthy Sedentary Older AdultsExperimentalParticipants 55-85 years of age will be randomized to either aerobic or non-aerobic exercise training.
Receives: Behavioral: Aerobic Exercise; Behavioral: Non-Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI

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

    Measured: 1.5 to 2 hours each at Visits 4 and 43

  2. Serum BDNF level

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

    Measured: 5 minutes each at Visits 4 and 43

  3. 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.

    Measured: 1.5 to 2 hours each at Visits 4 and 43

Secondary outcomes (1)

  1. Aerobic capacity and muscle strength

    Participants will perform two treadmill tests and several muscle strength tests to estimate baseline-to-follow-up change in aerobic capacity, measure change in time on treadmill, and determine change in muscle strength.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057354
Sponsor's protocol ID
H-32635
Other IDs
R00AG036845
Acronym
EMF
Status last verified
Apr 2018
First submitted
5 Feb 2014
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rosario MA, Kern KL, Mumtaz S, Storer TW, Schon K. Cardiorespiratory fitness is associated with cortical thickness of medial temporal brain areas associated with spatial cognition in young but not older adults. Eur J Neurosci. 2024 Jan;59(1):82-100. doi: 10.1111/ejn.16200. Epub 2023 Dec 6.

    PubMed 38056827

  • 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.

    PubMed 33325614

  • 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.

    PubMed 31588607

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise and Non-Aerobic Exercise in people with Aging, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI (time frame: 1.5 to 2 hours each at Visits 4 and 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057354, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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