ECEThe Entorhinal Cortex and Aerobic Exercise in Aging
Cardiovascular endurance
+ Strength, balance, and flexibility
Behavior+1
+ Motor Activity
+ Spatial Behavior
Prevention Study
Summary
Study start date: January 22, 2018
Actual date on which the first participant was enrolled.The investigators are examining the effects of exercise and cardiovascular fitness on cognitive processes. Specifically, the investigators are examining if exercise improves brain function in a brain area known as the entorhinal cortex. Together with the hippocampus this brain area is important for memory formation and spatial navigation. Participation in this research study will take approximately 4 months. During this time, participants will make three initial study visits. The first visit is for informed consent and screening, the second visit is for baseline fitness testing, and the third visit is for cognitive testing and a functional MRI exam. Functional MRI is a brain imaging technique that uses a magnetic field to "take pictures" of the brain while a person performs a cognitive task. It will take up to approximately three weeks to complete these initial three study visits. Following the three initial study visits, the exercise-training program will begin. Participants will be randomized to one of two training programs: a cardiovascular endurance-training program (aerobic exercise) and a strength, balance, and flexibility training program (non-aerobic exercise). 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 two follow-up study visits. The first follow-up visit is for fitness testing. The second follow-up visit is for cognitive testing and an MRI exam.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 60 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age between 60-80 years * Physical inactivity/sedentary status (The American College of Sports Medicine defines a sedentary lifestyle as a lifestyle in which a person is not participating in at least 30 minutes of moderate intensity physical activity on at least three days per week for at least three months.) * Generally healthy * Living in the greater Boston area * Fluent in English (must have attended elementary school and higher in English) * Non-smoking Exclusion Criteria: * Poor vision that cannot be corrected with glasses or contact lenses * Presence of an acute infection * Diagnosis of kidney failure * Diagnosis of liver disease * Diagnosis of thyrotoxicosis/hyperthyroidism * Diagnosis of cancer * Diagnosis of severe anemia * Past or present conditions that affect cognitive functioning: * learning disability * neurological disorders or conditions (movement disorder, history of head trauma or stroke, epilepsy, etc.) * psychiatric disorders or conditions within last 5 years (depression, anxiety disorder, etc.) * Severe stress * Evidence of cognitive impairment (e.g. dementia) * Claustrophobia (fear of small, enclosed spaces) * Obesity * Past or present conditions that are counter indicators for participation in cardio-respiratory fitness assessment and physical exercise: * heart conditions (e.g. heart attack, arrhythmias, etc.) * circulatory conditions (e.g. uncontrolled hypertension, leg claudication, 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. 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 * Prescription medication or other drugs that treat heart, lung, or circulatory conditions (e.g. beta blockers, bronchodilators, etc.) * Prescription medication or other drugs that affect chemicals in the brain (e.g. antidepressants, anxiolytics, etc.) * Drug abuse or alcohol misuse * Metal in or on the body that cannot be removed (e.g. pacemaker, defibrillator, metal implant that is ferrous) * Some known abnormal MRI findings (case by case basis) * Regularly exercising * Unavailable for the approx. 4-month duration of the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Boston University School of Medicine
Boston, United StatesOpen Boston University School of Medicine in Google Maps