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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
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of the aeRobic Exercise and Cognitive Health (REACH) study is to understand how an aerobic exercise intervention might help promote brain health and cognition, thereby delaying the onset of clinical symptoms of Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Aging Behavioral: Enhanced Physical Activity Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 45 and 80 at baseline visit.
  • Must be currently physically inactive (i.e. not meeting national guidelines of 150+ minutes per week of moderate exercise).
  • Participant is not pregnant at the time of the PET and MR imaging exams.
  • Willing and able to complete all assessments and exercise intervention faithfully.
  • Fluent and proficient in English language and capable of completing neuropsychological testing in English.
  • Participant must have physician clearance to participate in this study.

Exclusion Criteria:

  • Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma (10 min or more of loss of consciousness) followed by persistent neurologic deficits or known structural brain abnormalities.
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, body. X-ray may be used to establish suitability for MRI.
  • Inability to complete exercise test due to medical restrictions such as hip surgery, knee surgery, arthritis, or other orthopedic concerns that prevent being able to walk on a treadmill, type I or II diabetes mellitus, and documented vascular disease such as coronary artery disease.
  • Clinically significant findings from the exercise test that prohibit participation in moderate intensity exercise (i.e. 3rd degree heart block).
  • Current Axis I DSM-IV disorder including but not limited to major depression within the past two years, history of bipolar I disorder, history of schizophrenia spectrum disorders (DSM IV criteria).
  • History of alcohol or substance abuse or dependence (DSM IV criteria).
  • Any significant systemic illness or unstable medical condition that could affect cognition, CBF or BOLD, or cause difficulty complying with the exam. History of chemotherapy, thyroid disease, or renal insufficiency are excluded.
  • Severe untreated hypertension (>200/100mmHG).
  • Participants who do not have the cognitive competence and legal capacity to make informed medical decisions are excluded at entry. If a participant experiences significant cognitive decline during the study such that they no longer have medical decision making capacity the investigators will enact procedures that have been approved locally by the IRB and legal counsel at the University of Wisconsin-Madison: A) use their initial expressed and written consent as an indicator of willingness to continue to participate in the study; AND B) require that they provide assent at the time of follow-up visits witnessed and counter signed by their caregiver; AND C) signed consent from the patient's legally authorized representative.
  • Current use of antipsychotic medications such as non-SSRI antidepressants, neuroleptics, chronic anxiolytics, or sedative hypnotics, as well as some cardiac glycosides such as Digoxin.
  • Investigational agents are prohibited.
  • Exceptions to these criteria will be rare but may be considered on a case-by-case basis at the discretion of the investigators in consultation with study physicians.

Information from the National Library of Medicine

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


Locations
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United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Alzheimer's Association
Investigators
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Principal Investigator: Ozioma C. Okonkwo, PhD University of Wisconsin, Madison

Additional Information:
Publications:
U.S. Department of Health & Human Services. National Plan to Address Alzheimer's Disease: 2014 Update. Available at http://aspe.hhs.gov/daltcp/napa/NatlPlan2014.pdf. Accessed February 17, 2015.

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02384993     History of Changes
Other Study ID Numbers: 2014-1434
2014-NIRGD-305257 ( Other Grant/Funding Number: Alzheimer's Association )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:
Alzheimer's Disease
Dementia
aerobic exercise
physical activity
exercise
neuroimaging

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders