Exercise Effects on Brain Health and Learning From Minutes to Months (EXTEND)
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|ClinicalTrials.gov Identifier: NCT03114150|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : December 10, 2019
|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 :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
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|