Exercise Trial for Alzheimer's Disease (EXTRA)
|ClinicalTrials.gov Identifier: NCT01311492|
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Healthy Lifestyle Program Behavioral: Physical Activity Intervention||Not Applicable|
Alzheimer's disease (AD) occurs in 1 in 7 individuals over 65, and 1 in 2 individuals over 85. While the progression of AD is extremely variable, it is generally established that AD subjects will move from having compromised function in socail and work settings, to requiring institutionalization and/or intensive management within 10 years of initial clinical diagnosis. A randomized controlled piot trial is needed to provide information regarding exercies effects on individuals with mild to moderate Alzheimer's disease.
Exercise Trial for Alzheimer's Disease (EXTRA) is a pilot randomized controlled trial designed to compare a moderate-intesity physical activity program to a healthy lifestyle health education program in 30 older adults with mild to moderate Alzheimer's Disease. These individuals will be followed for 1 year.
This trial will provide pilot evidence regarding whether physical activity is effective and practical for individuals with AD. The effects of an exercise intervention on halting, slowing, or reversing the cognitive effects of AD will be assessed with pilot data and potentially provide support for a larger trial in the future.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Exercise Trial for Alzheimer's Disease (EXTRA)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
U.S. FDA Resources
Placebo Comparator: Healthy Lifestyle Program
The purpose of the healthy lifestyle group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest.
Behavioral: Healthy Lifestyle Program
The healthy lifestyle program includes upper body stretching and educational workshops. The purpose of this group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest. The rational for this "placebo exercise" activity is that it helps foster adherence to this arm of the study and increases the perceived benefit of the healthy lifestyle program to the participants without directly affecting the study outcomes.
Active Comparator: Physical Activity Intervention
The physical activity program includes aerobic, strenth, flexibility and balance training.
Behavioral: Physical Activity Intervention
The physical activity intervention consists of a general weekly physical activity goal of 150 minutes. This is consistent with the public health message from the Surgeon General's report that moderate physical activity should be performed for 30 minutes on most if not all days of the week (150-210 total minutes). This goal is approached in a progressive manner over the course of the trial.
- Effect of exercise on cognitive decline [ Time Frame: 6 months ]The primary hypothesis is that exercise will decrease the congnitive decline in activities of daily living, in the subjects with Alzheimer's Disease.
- Measuring the effects of exercise on depression, metabolic indices, and changes in overall function. [ Time Frame: 6 months ]The secondary hypothesis is that exercise will decrease the level of depression, improve multiple metabolic indices, and improve function in subjects with Alzheimer's Disease.
- Evidence based feasibility for conducting exercise interventions in the Alzheimer's Disease population. [ Time Frame: 6 months ]The third hypothesis is that well controlled exercise interventions can be successfully implemented in subjects with Alzheimer's Disease.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311492
|United States, Louisiana|
|Programs of All-Inclusive Care for the Elderly (PACE)|
|Baton Rouge, Louisiana, United States, 70806|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Timothy S. Church, MD, MPH, PhD||Pennington Biomedical Research Center|
|Principal Investigator:||Jeffrey N. Keller, PhD||Pennington Biomedical Research Center|
|Study Director:||Robert M. Brouilette, MS||Pennington Biomedical Research Center|
|Study Director:||Valerie H. Myers, PhD||Pennington Biomedical Research Center|
|Study Director:||Susan Nelson, MD||Programs of All-Inclusive Care for the Elderly (P.A.C.E.)|