Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01128361|
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Aerobic Exercise Behavioral: Stretching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alzheimer's Disease Exercise Prevention Trial|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
U.S. FDA Resources
|Experimental: Aerobic Exercise||
Behavioral: Aerobic Exercise
Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|Active Comparator: Stretching||
This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
- Memory Composite [ Time Frame: week 0, 13, and 26 ]
A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged.
Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
- Executive Function Composite [ Time Frame: Week 0, 13, and 26 ]
A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged.
Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
- Disability Assessment for Dementia [ Time Frame: Week 0, 13, and 26 ]This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.
- Cornell Scale for Depression in Dementia [ Time Frame: Week 0, 13, and 26 ]The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128361
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jeffrey Burns, MD||University of Kansas Medical Center|