aeRobic Exercise and Cognitive Health

NCT02384993 | Completed Results

• 4 other identifiers: 2014-14342014-NIRGD-305257A534255SMPH\MEDICINE\GER-AD DEV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; Aging

Keywords

Alzheimer's Disease; Dementia; aerobic exercise; physical activity; exercise; neuroimaging

Outcome Measures

Primary Outcomes (3)

• Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group

  This intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.

  up to 26 weeks

• Feasibility: Percentage of Participants Who Completed the Study

  Feasibility is in part defined as at least 90% of enrolled participants completed the study.

  up to 3 years

• Cerebral Glucose Metabolism as Measured by FDG PET Scanning

  Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning. This method measures the brain's use of blood sugar while in a resting state. Measurements were taken in the posterior cingulate cortex (PCC). An increase in this measure indicates an increase in the brain's uptake and usage of blood sugar.

  over 26 weeks (assessed at baseline visit and at week-26 visit)

Secondary Outcomes (7)

• Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity

  over 26 weeks (assessed at baseline visit and at week-26 visit)

• California Verbal Learning Test-II Total Score

  over 26 weeks (assessed at baseline visit and at week-26 visit)

• Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score

  up to 26 weeks (measured at baseline and 26 weeks)

• Mini Mental State Examination (MMSE) Score

  up to 26 weeks (assessed at baseline and 26 weeks)

• California Verbal Learning Test-II Long Delay Score

  over 26 weeks (assessed at baseline visit and at week-26 visit)

Other Outcomes (9)

• Ancillary Neuroimaging Measures

  over 26 weeks (assessed at baseline visit and at week-26 visit)

• Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)

  over 26 weeks (assessed at baseline visit and at week-26 visit)

• Brain Derived Neurotrophic Factor

  over 26 weeks (assessed at baseline visit and at week-26 visit)

Study Arms (2)

Enhanced Physical Activity

EXPERIMENTAL

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

Usual Physical Activity

NO INTERVENTION

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.

Interventions

Enhanced Physical Activity BEHAVIORAL

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.

Also known as: Aerobic Exercise (EXER)

Enhanced Physical Activity

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 positron emission tomography (PET) and magnetic resonance (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Alzheimer's Association: collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (10)

• 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.

  BACKGROUND

• Khachaturian ZS, Khachaturian AS. Prevent Alzheimer's disease by 2020: a national strategic goal. Alzheimers Dement. 2009 Mar;5(2):81-4. doi: 10.1016/j.jalz.2009.01.022. No abstract available.

  PMID: 19328433 BACKGROUND

• Sperling RA, Jack CR Jr, Aisen PS. Testing the right target and right drug at the right stage. Sci Transl Med. 2011 Nov 30;3(111):111cm33. doi: 10.1126/scitranslmed.3002609.

  PMID: 22133718 BACKGROUND

• Adlard PA, Perreau VM, Pop V, Cotman CW. Voluntary exercise decreases amyloid load in a transgenic model of Alzheimer's disease. J Neurosci. 2005 Apr 27;25(17):4217-21. doi: 10.1523/JNEUROSCI.0496-05.2005.

  PMID: 15858047 BACKGROUND

• Wu CW, Chang YT, Yu L, Chen HI, Jen CJ, Wu SY, Lo CP, Kuo YM. Exercise enhances the proliferation of neural stem cells and neurite growth and survival of neuronal progenitor cells in dentate gyrus of middle-aged mice. J Appl Physiol (1985). 2008 Nov;105(5):1585-94. doi: 10.1152/japplphysiol.90775.2008. Epub 2008 Sep 18.

  PMID: 18801961 BACKGROUND

• Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.

  PMID: 21282661 BACKGROUND

• Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Plymate SR, Fishel MA, Watson GS, Cholerton BA, Duncan GE, Mehta PD, Craft S. Effects of aerobic exercise on mild cognitive impairment: a controlled trial. Arch Neurol. 2010 Jan;67(1):71-9. doi: 10.1001/archneurol.2009.307.

  PMID: 20065132 BACKGROUND

• Barnes DE, Yaffe K. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep;10(9):819-28. doi: 10.1016/S1474-4422(11)70072-2. Epub 2011 Jul 19.

  PMID: 21775213 BACKGROUND

• Jarvik L, LaRue A, Blacker D, Gatz M, Kawas C, McArdle JJ, Morris JC, Mortimer JA, Ringman JM, Ercoli L, Freimer N, Gokhman I, Manly JJ, Plassman BL, Rasgon N, Roberts JS, Sunderland T, Swan GE, Wolf PA, Zonderman AB. Children of persons with Alzheimer disease: what does the future hold? Alzheimer Dis Assoc Disord. 2008 Jan-Mar;22(1):6-20. doi: 10.1097/WAD.0b013e31816653ac.

  PMID: 18317242 BACKGROUND

• Gaitan JM, Boots EA, Dougherty RJ, Oh JM, Ma Y, Edwards DF, Christian BT, Cook DB, Okonkwo OC. Brain Glucose Metabolism, Cognition, and Cardiorespiratory Fitness Following Exercise Training in Adults at Risk for Alzheimer's Disease. Brain Plast. 2019 Dec 26;5(1):83-95. doi: 10.3233/BPL-190093.

  PMID: 31970062 RESULT

Related Links

• U.S. Department of Health \& Human Services. National Plan to Address Alzheimer's Disease: 2014 Update

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Ozioma C. Okonkwo
• Organization: University of Wisconsin - Madison

ozioma@medicine.wisc.edu

(608) 265-4479

Study Officials

• Ozioma C. Okonkwo, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 10, 2015
• Study Start: April 28, 2015
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: March 18, 2024
• Results First Posted: March 30, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)