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CompletedNCT02384993REACHUpdated Mar 18, 2024Results posted

aeRobic Exercise and Cognitive Health

An interventional study of Enhanced Physical Activity in Alzheimer's Disease and Aging, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

The prevalence and costs associated with Alzheimer's disease (AD) are projected to increase exponentially owing to the unprecedented expansion in the elderly segment of the United States' population. Given this looming specter, delaying the onset of AD symptoms and curbing the progression of the underlying disease process has become a national public health imperative. Delaying symptom onset by as little as 5 years could reduce the prevalence of AD by half. Unfortunately, currently available drug treatments for AD are not curative. Similarly, clinical trials testing novel disease-modifying therapeutics have been disappointing. The urgency of alternative approaches for halting the global crisis posed by AD cannot be overstated.

Animal studies have demonstrated that aerobic exercise (EXER) is a low-cost, low-risk intervention capable of altering the AD pathological process. Randomized controlled trials (RCTs) of EXER in older adults have also revealed its beneficial effects on AD-relevant measures such as brain glucose metabolism and memory/executive function. Importantly, a recent evidence review found that of 7 key modifiable risk factors for AD, physical activity had the highest impact on reducing the national prevalence of AD. However, there are presently no RCTs examining the effects of EXER in middle-aged, asymptomatic individuals at increased risk of AD. This is an important knowledge gap for several reasons. Interventions to halt the AD pathological cascade are more likely to be effective if implemented prior to pervasive neuronal damage. Secondly, persons with specific risk factors for developing AD (such as parental family history (FH)) represent a choice target population for any credible attempts at reducing the growing burden of AD. Lastly, a key limitation of prior EXER RCTs is the failure to adequately account for participants' physical activity levels outside of the intervention.

Accordingly, the main objective of this study is to pilot a 26-week trial of EXER among asymptomatic, middle-aged adults with and without family history (FH) of AD enrolled in the Wisconsin Registry for Alzheimer's Prevention (WRAP) or the Wisconsin Alzheimer's Disease Research Center (WADRC). The investigators' near-term goal is to assess the feasibility and acceptability of this structured intervention and preliminarily evaluate (i) its effect on AD-relevant outcomes such as glucose metabolism and (ii) the mechanism for such effects. The investigators' longer-term goal is to use the data gathered via this pilot to further refine the intervention, estimate effect sizes for key outcomes, and seek NIH funding for a longer and more definitive assessment of whether EXER can effectively curtail AD progression in midlife. The specific aims are:

AIM 1: Determine the feasibility and acceptability of a 26-week, 3-4 days per week, structured EXER regimen among middle-aged adults with FH of AD. Hypothesis: The investigators will successfully enroll the 30 participants (15 each in EXER and usual physical activity groups) targeted for this study. At least 90% of the participants within the EXER group, called the enhanced physical activity group, will complete ≥80% of scheduled training sessions.

AIM 2: Preliminarily characterize the effect of the EXER intervention on AD-related brain alteration. Hypothesis: Compared to participants randomized to the usual physical activity group, those randomized to the enhanced physical activity group will demonstrate preserved brain glucose metabolism. Similar effects will be seen in secondary outcomes including cerebral blood flow, hippocampal volume, vascular health, memory/executive function, and mood.

AIM 3: Preliminarily evaluate (i) the biological mechanisms by which EXER affects brain health and cognition, and (ii) the individual difference factors that potentially moderate EXER's effects. Hypotheses: (i) Persons in the enhanced physical activity group will exhibit significant increases in circulating neurotrophins and improved cardiorespiratory fitness, and (ii) the beneficial effects of EXER will be more pronounced for participants with decreased sedentary behaviors outside of the intervention (measured via accelerometry).

AIM 4: Preliminarily determine whether EXER improves vascular health. Hypothesis: Individuals in the enhanced physical activity group will exhibit comparatively increased cerebral blood flow, and improved endothelial function.

02

Conditions studied

  • Alzheimer's Disease
  • Aging

Browse trials for

Keywords

  • Alzheimer's Disease
  • Dementia
  • aerobic exercise
  • physical activity
  • exercise
  • neuroimaging
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 24 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralEnhanced 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.

    Also known as: Aerobic Exercise (EXER)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 26 weeks

  2. Feasibility: Percentage of Participants Who Completed the Study

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

    Time frame: up to 3 years

  3. 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.

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

Secondary outcomes

  1. Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity

    Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.

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

  2. California Verbal Learning Test-II Total Score

    The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.

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

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

    The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.

    Time frame: up to 26 weeks (measured at baseline and 26 weeks)

  4. Mini Mental State Examination (MMSE) Score

    The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.

    Time frame: up to 26 weeks (assessed at baseline and 26 weeks)

  5. California Verbal Learning Test-II Long Delay Score

    The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.

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

  6. Profile of Mood States (POMS) Score

    The Profile of Mood States was used to assess mood. POMS is divided into six subscales including tension-anxiety (9 items, score range: 0-36), depression (15 items, range: 0-60), anger-hostility (12 items, range: 0-48), vigor-activity (8 items, range: 0-32), fatigue (7 items, range: 0-28), and confusion-bewilderment (7 items, range: 0-28). Total mood disturbance is calculated by adding five of the six subscales (Tension, Depression, Anger, Fatigue, and Confusion) and subtracting Vigor (Scores range from -32 to 200). Lower scores typically indicate more steady mood profiles. Higher scores indicate more mood disturbance.

    Time frame: up to 26 weeks (assessed at baseline and 26 weeks)

  7. Change in Hippocampal Volume

    Hippocampal volume will be assessed using T1-weighted 3T MRI images.

    Time frame: up to 26 weeks (assessed at baseline and 26 weeks)

Other outcomes

  1. Ancillary Neuroimaging Measures

    Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.

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

  2. Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)

    The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.

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

  3. Brain Derived Neurotrophic Factor

    The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.

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

  4. Vascular Endothelial Growth Factor

    Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.

    Time frame: over 26 weeks (assessed at baseline visit and at week-26 visit

  5. Arterial Plaque Presence

    Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.

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

  6. Subclinical Atherosclerosis Burden

    Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.

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

  7. Endothelial Function

    Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.

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

  8. Sedentary Behavior Measured Via Accelerometer

    Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.

    Time frame: up to 26 weeks (measured at baseline and 26 weeks)

  9. Moderate to Vigorous Physical Activity (MVPA)

    Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.

    Time frame: up to 26 weeks (assessed at baseline and 26 weeks)

07

Results

Posted Mar 30, 2020

Participant flow

Participant flow — Overall Study
MilestoneUsual Physical ActivityEnhanced Physical Activity
Started1212
Completed1211
Not completed01
Withdrew: Adverse event01

Outcome measures

PrimaryAcceptability: 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.

Time frame:
up to 26 weeks
Reported as:
Mean · Percentage of Sessions
Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group
Percentage of SessionsEnhanced Physical Activity
Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group99.2 ± 2.7
PrimaryFeasibility: Percentage of Participants Who Completed the Study

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

Time frame:
up to 3 years
Reported as:
Count of participants · Participants
Feasibility: Percentage of Participants Who Completed the Study
ParticipantsUsual Physical ActivityEnhanced Physical Activity
Feasibility: Percentage of Participants Who Completed the Study1211
PrimaryCerebral 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.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Mean · arbitrary units
Cerebral Glucose Metabolism as Measured by FDG PET Scanning
arbitrary unitsUsual Physical ActivityEnhanced Physical Activity
baseline1.49 ± 0.041.50 ± 0.03
26 weeks1.52 ± 0.041.54 ± 0.04
SecondaryUltrasound-Measured Cerebral Blood Flow - Mean Flow Velocity

Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Median · cm/second
Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity
cm/secondUsual Physical ActivityEnhanced Physical Activity
Baseline45.05 (42.59 to 47.51)41.13 (33.97 to 48.29)
26 Weeks49.47 (42.16 to 56.78)45.85 (37.35 to 54.36)
SecondaryCalifornia Verbal Learning Test-II Total Score

The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Mean · words
California Verbal Learning Test-II Total Score
wordsUsual Physical ActivityEnhanced Physical Activity
baseline49.58 ± 11.0653.18 ± 7.99
26 weeks53.33 ± 9.1860.64 ± 9.04
SecondaryDelis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score

The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.

Time frame:
up to 26 weeks (measured at baseline and 26 weeks)
Reported as:
Mean · seconds
Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score
secondsUsual Physical ActivityEnhanced Physical Activity
baseline60.00 ± 11.7164.82 ± 15.11
26 weeks60.00 ± 11.9957.64 ± 11.96
SecondaryMini Mental State Examination (MMSE) Score

The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.

Time frame:
up to 26 weeks (assessed at baseline and 26 weeks)
Reported as:
Mean · scores on a scale
Mini Mental State Examination (MMSE) Score
scores on a scaleUsual Physical ActivityEnhanced Physical Activity
baseline29.67 ± 0.4929.55 ± 0.69
26 weeks29.08 ± 1.2429.55 ± 0.52
SecondaryCalifornia Verbal Learning Test-II Long Delay Score

The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Mean · words
California Verbal Learning Test-II Long Delay Score
wordsUsual Physical ActivityEnhanced Physical Activity
baseline10.83 ± 2.8312.00 ± 2.72
26 weeks11.42 ± 3.2614.00 ± 1.73
SecondaryProfile of Mood States (POMS) Score

The Profile of Mood States was used to assess mood. POMS is divided into six subscales including tension-anxiety (9 items, score range: 0-36), depression (15 items, range: 0-60), anger-hostility (12 items, range: 0-48), vigor-activity (8 items, range: 0-32), fatigue (7 items, range: 0-28), and confusion-bewilderment (7 items, range: 0-28). Total mood disturbance is calculated by adding five of the six subscales (Tension, Depression, Anger, Fatigue, and Confusion) and subtracting Vigor (Scores range from -32 to 200). Lower scores typically indicate more steady mood profiles. Higher scores indicate more mood disturbance.

Time frame:
up to 26 weeks (assessed at baseline and 26 weeks)
Reported as:
Mean · score on a scale
Profile of Mood States (POMS) Score
score on a scaleUsual Physical ActivityEnhanced Physical Activity
Baseline Tension8.00 ± 2.927.67 ± 3.11
Post-intervention Tension8.64 ± 3.416.00 ± 3.82
Baseline Depression5.17 ± 6.604.83 ± 6.64
Post-intervention Depression5.36 ± 5.523.27 ± 5.53
Baseline Anger3.17 ± 4.495.50 ± 4.98
Post-intervention Anger4.27 ± 3.413.82 ± 5.10
Baseline Vigor16.83 ± 6.3116.25 ± 6.86
Post-intervention Vigor16.25 ± 6.8615.36 ± 4.74
Baseline Fatigue4.92 ± 3.556.58 ± 5.25
Post-intervention Fatigue7.64 ± 4.155.91 ± 4.70
Baseline Confusion5.17 ± 2.956.83 ± 2.52
Post-intervention Confusion5.55 ± 3.055.45 ± 3.17
Baseline Total Mood Disturbance9.58 ± 19.7115.17 ± 19.94
Post-intervention Total Mood Disturbance16.09 ± 15.647.55 ± 20.47
SecondaryChange in Hippocampal Volume

Hippocampal volume will be assessed using T1-weighted 3T MRI images.

Time frame:
up to 26 weeks (assessed at baseline and 26 weeks)
Reported as:
Mean · mm cubed
Change in Hippocampal Volume
mm cubedUsual Physical ActivityEnhanced Physical Activity
Change in Hippocampal Volume-23.67 ± 222.50-33.64 ± 177.00
Other pre-specifiedAncillary Neuroimaging Measures

Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.

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

Results for this outcome have not been posted.

Other pre-specifiedCardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)

The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Mean · mL/kg/min
Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)
mL/kg/minUsual Physical ActivityEnhanced Physical Activity
baseline25.74 ± 6.5823.57 ± 4.97
26 weeks27.18 ± 6.0527.46 ± 4.71
Other pre-specifiedBrain Derived Neurotrophic Factor

The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.

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

Results for this outcome have not been posted.

Other pre-specifiedVascular Endothelial Growth Factor

Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit

Results for this outcome have not been posted.

Other pre-specifiedArterial Plaque Presence

Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.

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

Results for this outcome have not been posted.

Other pre-specifiedSubclinical Atherosclerosis Burden

Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.

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

Results for this outcome have not been posted.

Other pre-specifiedEndothelial Function

Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.

Time frame:
over 26 weeks (assessed at baseline visit and at week-26 visit)
Reported as:
Mean · Percentage of dilation
Endothelial Function
Percentage of dilationUsual Physical ActivityEnhanced Physical Activity
Baseline2.22 ± 1.781.86 ± 0.93
26 Weeks2.71 ± 1.692.33 ± 1.71
Other pre-specifiedSedentary Behavior Measured Via Accelerometer

Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.

Time frame:
up to 26 weeks (measured at baseline and 26 weeks)
Reported as:
Mean · minute/day
Sedentary Behavior Measured Via Accelerometer
minute/dayUsual Physical ActivityEnhanced Physical Activity
Baseline670.73 ± 27.2726.0 ± 22.9
26 weeks690.1 ± 26.7698.6 ± 27.1
Other pre-specifiedModerate to Vigorous Physical Activity (MVPA)

Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.

Time frame:
up to 26 weeks (assessed at baseline and 26 weeks)
Reported as:
Mean · minute/day
Moderate to Vigorous Physical Activity (MVPA)
minute/dayUsual Physical ActivityEnhanced Physical Activity
baseline78.97 ± 10.1960.58 ± 7.08
26 weeks69.3 ± 8.3789.05 ± 15.48

Adverse events

Collected over up to 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced Physical Activity0/12 (0%)0/12 (0%)1/12 (8.3%)
Usual Physical Activity0/12 (0%)0/12 (0%)0/12 (0%)
Most frequent other events
Most frequent other events
EventEnhanced Physical ActivityUsual Physical Activity
Hip SurgeryMusculoskeletal and connective tissue disorders1/120/12

Baseline characteristics

Measures reported for participants who completed the study.

Age, Customized
Age, Customized(Participants)Usual Physical ActivityEnhanced Physical ActivityTotal
Age — 50-59 years415
Age — 60-69 years7916
Age — 70-79 years123
Sex: Female, Male
Sex: Female, Male(Participants)Usual Physical ActivityEnhanced Physical ActivityTotal
Female6511
Male6713
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Usual Physical ActivityEnhanced Physical ActivityTotal
Hispanic or Latino000
Not Hispanic or Latino121224
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Usual Physical ActivityEnhanced Physical ActivityTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White121224
More than one race000
Unknown or Not Reported000
Years of Education
Years of Education(years)Usual Physical ActivityEnhanced Physical ActivityTotal
Mean16.67 ± 2.5716.58 ± 2.4716.62 ± 2.46
Number of Participants with APOE e4 positive
Number of Participants with APOE e4 positive(Participants)Usual Physical ActivityEnhanced Physical ActivityTotal
Count of participants549
BMI
BMI(kg/m^2)Usual Physical ActivityEnhanced Physical ActivityTotal
Mean29.38 ± 5.9629.37 ± 4.9329.37 ± 5.35
Systolic blood pressure
Systolic blood pressure(mmHg)Usual Physical ActivityEnhanced Physical ActivityTotal
Mean128.50 ± 19.65121.88 ± 18.39125.19 ± 18.92

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin 53792, United States
09

References and documents

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.
  • 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. PubMed 19328433 ↗
  • 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. PubMed 22133718 ↗
  • 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. PubMed 15858047 ↗
  • 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. PubMed 18801961 ↗
  • 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. PubMed 21282661 ↗
  • 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. PubMed 20065132 ↗
  • 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. PubMed 21775213 ↗
  • 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. PubMed 18317242 ↗
  • 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. PubMed 31970062 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02384993
Lead sponsor
University of Wisconsin, Madison
Collaborators
Alzheimer's Association
Responsible party
Sponsor
First posted
Mar 10, 2015
Start date
Apr 28, 2015
Primary completion
Jul 19, 2016
Completion
Jul 19, 2016
Results posted
Mar 30, 2020
Last update
Mar 18, 2024

Study contacts

Ozioma C. Okonkwo, PhD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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