Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

Not Applicable

Completed

• Conditions: Alzheimer's Disease Prevention
• Interventions: Behavioral: Aerobic vs. Non-Aerobic exercise

• Registration Number: NCT01834716
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-03-21
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-21
• Last Update Submitted: 2018-12-21
• Results First Posted: 2019-03-29
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Aerobics Exercise	Aerobic vs. Non-Aerobic 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.
Aerobics exercise	Aerobic vs. Non-Aerobic exercise	Participants in this group will be randomized to aerobics exercise (the equivalent of walking briskly for 50 minutes three times per week).

Primary Outcome Measures

Name	Time	Method
Number of Subjects Retained at 6 Months	6 months	The number of subjects retained at 6 month end of study time point.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States