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Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).
After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire.
Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.
Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobics exercise | Experimental | Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week). |
|
| Non-Aerobics Exercise | Experimental | Participants in this group will be randomized to a non-aerobics (attending classes of toning and stretching a minimum of three times per week) exercise group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic vs. Non-Aerobic exercise | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Retained at 6 Months | The number of subjects retained at 6 month end of study time point. | 6 months |
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| Name | Affiliation | Role |
|---|---|---|
| Neill Graff-Radford, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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Participants were recruited via study invitations mailed to persons by age and zip code. Local community presentations were also conducted to recruit subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Aerobics Exercise | Participants in this group will be randomized to a non-aerobics(attending classes of toning and stretching a minimum of three times per week) exercise group. |
| FG001 | Aerobics Exercise | Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-aerobics Exercise | Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week). |
| BG001 | Aerobics Exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Retained at 6 Months | The number of subjects retained at 6 month end of study time point. | Posted | Count of Participants | Participants | 6 months |
|
Adverse events were collected at baseline, 3 months, and 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aerobics Exercise | Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neill Graff-Radford | Mayo Clinic | 9049537103 | graffradford.neill@mayo.edu |
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Participants in this group will be randomized to an aerobics exercise group (the equivalent of walking briskly for 50 minutes three times per week).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 0 |
| 12 |
| EG001 | Non-Aerobics Exercise | Participants in this group will be randomized to a non-aerobics exercise group (attending classes of toning and stretching a minimum of three times per week). | 0 | 4 | 0 | 4 | 0 | 4 |
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