An interventional study of Aerobic Exercise and Standard of Care in Alzheimer's Disease, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
The purpose of this study is to learn about the possible benefits of aerobic exercise in controlling or reducing the amount of amyloid present in the brain, reducing changes in brain structure that may lead to Alzheimer's Disease (AD), and increasing cognitive ability in individuals that have amyloid deposits and are at risk to develop AD.
3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 117 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exercise 150 minutes per week (over 3 to 5 days) for 52 weeks
Other: Aerobic Exercise
Standard of Care exercise recommendations
Other: Standard of Care
Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
Also known as: Standard of Care for exercise recommendations
Amyloid Burden
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
Time frame: Baseline to 52 weeks
Whole Brain Volume
Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
Time frame: Baseline to 52 weeks
Executive Function
Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.
Time frame: Baseline to Week 52
| Milestone | Aerobic Exercise Group | Control Group |
|---|---|---|
| Started | 78 | 39 |
| Completed | 75 | 34 |
| Not completed | 3 | 5 |
Amyloid burden measure is mean Florbetapir cortical-to-cerebellar uptake ratio averaged across 6 regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus). Higher numbers mean more amyloid accumulation. There is no defined maximum value. Zero is the theoretical minimum value.
| Standard Uptake Value Ratio (SUVR) | Aerobic Exercise Group | Control Group |
|---|---|---|
| Baseline | 1.20 ± .2 | 1.22 ± .2 |
| Follow-up | 1.21 ± .2 | 1.22 ± .2 |
Whole brain volume in mL define by Freesurfer analysis. Higher numbers indicate greater brain volume. There is no defined maximum. Zero is the theoretical minimum.
| mL | Aerobic Exercise Group | Control Group |
|---|---|---|
| Baseline | 1068.7 ± 109.7 | 1061.7 ± 114.4 |
| Follow-up | 1063.4 ± 109.1 | 1059.1 ± 115.1 |
Executive Function ability to be measured using confirmatory factor analysis (CFA). CFA aggregates scores from across multiple subtests. Values are standard deviations centered on a pooled baseline (all participant scores at baseline). Higher values mean improvement over baseline testing. Lower scores (including negative) mean worse performance after baseline testing. There is no minimum or maximum score.
| Standard Deviations | Aerobic Exercise Group | Control Group |
|---|---|---|
| Baseline | 0.029 ± .46 | -0.042 ± .37 |
| Week 26 | 0.017 ± 0.63 | -0.035 ± 0.39 |
| Follow-up | .018 ± .62 | -0.037 ± 0.45 |
Collected over One year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aerobic Exercise Group | 0/78 (0%) | 8/78 (10.3%) | 23/78 (29.5%) |
| Control Group | 0/39 (0%) | 4/39 (10.3%) | 4/39 (10.3%) |
| Event | Aerobic Exercise Group | Control Group |
|---|---|---|
| Infection with unknown ANCInfections and infestations | 4/78 | 1/39 |
| Supraventricular TachycardiaCardiac disorders | 0/78 | 1/39 |
| Lower extremity arthroplastyMusculoskeletal and connective tissue disorders | 1/78 | 1/39 |
| Acute Pyelonephritis with urinary tract infectionRenal and urinary disorders | 0/78 | 1/39 |
| Hepatobiliary inflammationHepatobiliary disorders | 1/78 | 0/39 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/78 | 0/39 |
| Fall and hip fracture requiring fixationInjury, poisoning and procedural complications | 1/78 | 0/39 |
| Event | Aerobic Exercise Group | Control Group |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 23/78 | 4/39 |
| Age, Categorical(Participants) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 78 | 39 | 117 |
| Age, Continuous(years) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| Mean | 72.2 ± 5.3 | 71.2 ± 4.8 | 71.5 ± 5.0 |
| Sex: Female, Male(Participants) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| Female | 55 | 24 | 79 |
| Male | 23 | 15 | 38 |
| Ethnicity (NIH/OMB)(Participants) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 78 | 39 | 117 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 77 | 35 | 112 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Aerobic Exercise Group | Control Group | Total |
|---|---|---|---|
| United States | 78 | 39 | 117 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Kansas Medical Center