aeRobic Exercise and Cognitive Health (REACH)
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|ClinicalTrials.gov Identifier: NCT02384993|
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Aging||Behavioral: Enhanced Physical Activity||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aerobic Exercise for Alzheimer's Disease Prevention in At-Risk Middle-Aged Adults|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Enhanced Physical Activity
Those assigned to the enhanced physical activity group will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training, and maintaining this level of exercise for the remainder of the 26-week intervention. A gradual increase in exercise intensity and duration will be used throughout this twenty-six week exercise intervention, with the initial speed and duration calibrated to each participant's baseline aerobic capacity. Training will occur in individual sessions supervised by exercise specialists with the appropriate education and experience. Each training session will begin with an appropriate warm-up, slowly build up, and end with an appropriate cool down period.
Behavioral: Enhanced Physical Activity
This is a 26-week aerobic exercise intervention. The primary mode of training is treadmill walking, with the initial speed and duration calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining 150+ minutes of exercise per week by the seventh week. Exercise will be set between 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be approximately 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period.
Other Name: Aerobic Exercise (EXER)
No Intervention: Usual Physical Activity
All study participants randomized to the usual physical activity group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise & Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
- Cerebral Glucose Metabolism [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) PET scanning. This method measures the brain's use of sugar while in a resting state.
- Ancillary neuroimaging measures [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.
- Cognition/Mood [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]The California Verbal Learning Test-II and Delis-Kaplan Executive Function System will be used to measure memory and executive function. The Profile of Mood States will be used to assess mood.
- Cardiorespiratory Fitness/Physical Activity [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]The investigators will examine exercise tests and accelerometer data to assess changes in fitness or physical activity.
- Brain Derived Neurotrophic Factor [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.
- Vascular Endothelial Growth Factor [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit ]Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.
- Ultrasound-Measured Cerebral Blood Flow [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.
- Arterial Plaque Presence [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.
- Subclinical Atherosclerosis Burden [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.
- Endothelial Function [ Time Frame: over 26 weeks (assessed at baseline visit and at week-26 visit) ]Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.
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): NCT02384993
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Ozioma C. Okonkwo, PhD||University of Wisconsin, Madison|