Exercise Effects on Brain Health and Learning From Minutes to Months (EXTEND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03114150|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle||Behavioral: Cardiorespiratory fitness training Behavioral: Functional fitness training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Exercise to Improve Hippocampal Connectivity and Learning in Older Adults|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2024|
Experimental: Cardiorespiratory fitness training
Cardiorespiratory fitness training will be a 24-week supervised cycling program designed to improve cardiorespiratory fitness, with supervision directly from the research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes moderate intensity cycling and 30 minutes light intensity cycling, and 5 minute cool-down per session, for 3 sessions/week. In each additional week, 6 minutes of moderate intensity cycling per session will be added, until the total time for moderate intensity is 50 minutes per session by the start of week 5 (with additional 5 minute warm-up and 5 minute cool-down).
Behavioral: Cardiorespiratory fitness training
Physical exercise of moderate intensity designed to improve cardiorespiratory fitness
Active Comparator: Functional fitness training
Functional fitness training will be a 24-week supervised exercise program designed to focus on functional flexibility and mobility, with supervision directly from our research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes of light intensity cycling and 20 minutes of dynamic stretching to increase range of motion and functional fitness, for 3 sessions/week. In each additional week, additional stretches will be added to maintain variety and improve flexibility of all major muscle groups.
Behavioral: Functional fitness training
Physical exercise of light intensity designed to improve functional fitness
- Change in hippocampal-dependent learning [ Time Frame: Baseline, 24-weeks ]Learning rate on constructs that have been examined in animal models including context acquisition, episodic associations, and spatial navigation.
- Change in hippocampal-cortical functional connectivity [ Time Frame: Baseline, 30 minutes ]The strength of the correlation between the spontaneous functional magnetic resonance imaging (fMRI) signal in the hippocampus and cortical regions in a hippocampal-cortical memory system.
- Change in hippocampal-cortical functional connectivity [ Time Frame: Baseline, 24-weeks ]The strength of the correlation between the spontaneous functional magnetic resonance imaging (fMRI) signal in the hippocampus and cortical regions in a hippocampal-cortical memory system.
- Change in cardiorespiratory fitness [ Time Frame: Baseline, 24-weeks ]Cardiorespiratory fitness will be measured during a maximal exercise test. Oxygen uptake (VO2) will be measured from expired air samples taken at 30 second intervals until a peak VO2, the highest VO2, is attained at the point of test termination due to symptom limitation and/or volitional exhaustion.
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|Ages Eligible for Study:||55 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40.
- Approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below.
- Exercising less than 60 minutes a week for the past calendar year
- Not between the ages of 55 and 80 years old
- Not fluent in English
- Score < 20 (out of 30) on the Montreal Cognitive Assessment (MoCA)
- Inability to comply with experimental instructions
- Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine
- Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness
- Inability to complete an MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114150
|Contact: Michelle W Voss, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242-1401|
|Contact: Michelle Voss 319-335-2057 email@example.com|
|Principal Investigator:||Michelle W Voss, PhD||University of Iowa|
Documents provided by Michelle W. Voss, University of Iowa:
|Responsible Party:||Michelle W. Voss, Associate Professor of Psychological and Brain Sciences, University of Iowa|
|Other Study ID Numbers:||
|First Posted:||April 14, 2017 Key Record Dates|
|Last Update Posted:||May 24, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||In accord with NIH regulations, the investigators will make the data and relevant documentation available to other investigators upon acceptance of the main findings from the study for publication. The investigators will share analysis tools as they are developed. Because the collected data are to remain anonymous, only a subject number will identify all data. To further protect the privacy and confidentiality of the data, data and documentation will be made available only under a data-sharing agreement that provides for restrictions for the transferring of data to others and a commitment that the data will be used for research purposes only and not for a profit-making enterprise.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
|Time Frame:||We will share baseline neuroimaging data and phenotypic data upon completion of data collection. We will share the intervention outcome data after we have published our results from each primary aim.|
|Access Criteria:||We will share on an open platform such as OpenNeuro (https://openneuro.org/).|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
learning and memory