View Clinical Trial (Medical Research Study)
Exercise Trial for Alzheimer's Disease (EXTRA)
| City: |
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Baton Rouge |
| State: |
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Louisiana |
| Zip Code: |
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70808 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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Exercise Trial for Alzheimer's Disease(EXTRA) is a pilot randomized clinical trial involving
a physcial activity program versus a healthy lifestyle program, with one year follow-up in
30 non-disabled, community-dwelling persons, age 65 and older.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- 65 years and older
- must be planning to reside in the area for 1 year
- summary scor of greater than or equal to 3 on the Short Physical
Performance Battery (SPPB)
- have mild to moderate AD defined by a score of 12-24 on the Mini-Mental Status
Examination (MMSE). Diagnosis of probable AD from site physician utilizing the
following criteria: Diagnostic and Statistical Manual of Mental Disorders-Fourth
Edition (DSM-IV) criteria for Dementia of Alzheimer's Type, National Institute of
Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and
Related Disorders Association (NINCDS/ADRDA) Criteria for Probable Alzheimer's
Disease, and Hachinski Ischemic Score is less than or equal to 4
- sedentary lifestyle which is operationally defined as spending less than 20 minutes a
week in the past month getting regular physical activity.
- must be willing to give informed consent, be willing to be randomized to either
physical activity or health lifestyle intervention, and to follow the protocol for
the group to which they have been assigned
Exclusion Criteria:
- unable or unwilling to give informed consent or accept randomization in either study
group
- current diagnosis of schizophreniz, other psychotic disorders, or bipolar disorder
- current consumption of more than 14 alcoholic drinks per week
- plans to relocate to out of the study area within the next year or plans to be out of
the study area for more than 6 weeks in the next year
- score of greater than 3 on SPPB
- another member of the household is a participant in they study
- residence too far from the intervention site
- difficulty in communication with study personnel due to speech or hearing problems
- MMSE less than 12 or greater than 24
- currently enrolled in another randomized trial involving lifestyle or phamaceutical
interventions
- other medical, psychiatric, or behavioral factors that in the judgement of the
Principal Investigator may interfere with study participation or the ability to
follow the intervention protocol
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| NCT ID: |
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NCT01311492 |
| Primary Contact: |
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Principal Investigator
Timothy S. Church, MD, MPH, PhD
Pennington Biomedical Research Center
Benjamin P. Butitta, BS
Phone: 225-763-2930
Email: Ben.Butitta@pbrc.edu
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| Backup Contact: |
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Email: Johanna.Veal@pbrc.edu
Johanna E. Veal, BS
Phone: 225-763-2692
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| Location Contact: |
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Baton Rouge, Louisiana 70808
United States
Benjamin M. Butitta, BS
Phone: 225-763-2930
Email: Ben.Butitta@pbrc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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