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Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Deseret Foundation
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00403507
First received: November 21, 2006
Last updated: May 9, 2011
Last verified: November 2006

November 21, 2006
May 9, 2011
October 2006
October 2009   (final data collection date for primary outcome measure)
  • For the intervention group: Change in cognitive performance relative to baseline [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • Group differences in cognitive performance following intervention and relative to wait-list control group [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • For the intervention group: Change in cognitive performance relative to baseline
  • Group differences in cognitive performance following intervention and relative to wait-list control group
  • For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline
  • Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group
Complete list of historical versions of study NCT00403507 on ClinicalTrials.gov Archive Site
  • For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group [ Time Frame: baseline & 20 week follow-up ] [ Designated as safety issue: No ]
  • For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes
  • Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group
Not Provided
Not Provided
 
Exercise Treatment of Mild-Stage Probable Alzheimer's Disease
Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease

The purpose of the study is to determine if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities (e.g., husband, wife, adult child, or caregiver).

Currently, there is no cure for the memory loss associated with Alzheimer's disease, though some medications can help it from getting worse. The research study will help to answer the question if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities.

The research study is a randomized-control trial: some participants will be picked to participate in the exercise program, while others will not. Their memory, thinking abilities, activities, and attitudes will be measured at baseline and follow-up assessment 5-6 months later. Participants are in good health, and are treated with a cholinesterase inhibitor for memory loss (standard treatment).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alzheimer Disease
  • Memory Disorders
  • Dementia
  • Behavioral: Participation in a monitored exercise program
    No contact with control group during 20 weeks.
  • Behavioral: Personalized aerobic and strength training.
    Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
  • No Intervention: Clean Control
    Probable Alzheimer's disease in the context of no excluding medical conditions.
    Intervention: Behavioral: Participation in a monitored exercise program
  • No Intervention: CoMorbid Control
    Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.
    Intervention: Behavioral: Participation in a monitored exercise program
  • Experimental: Clean Exercise
    Probable Alzheimer's disease in the context no comorbid medical conditions.
    Intervention: Behavioral: Personalized aerobic and strength training.
  • Experimental: CoMorbid Exercise
    Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.
    Intervention: Behavioral: Personalized aerobic and strength training.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age is 65 through 89 years old.
  • Completed more than an 8th grade education.
  • Native English speaker.
  • Diagnosis of probable Alzheimer's disease by a primary care physician or specialty clinic.
  • Taking a cholinesterase inhibitor at a therapeutic dose for at least two weeks prior to admission to study (following minimum titration of four weeks), but no other prescribed medication for cognitive functioning (e.g., memantine/Namenda).
  • May have one unstable physical illness that is being treated or a few controlled physical illnesses, is on few medications, and appears no more than mildly ill.
  • Treated stable hypertension & hyperlipidemia are permissible, but resting blood pressure must be <170/100 mm Hg.
  • Normal TSH & Vitamin B12 levels, as confirmed by laboratory data within 3 years.
  • Able to participate a three-day/week physical activity program (No orthopedic, neurologic, or behavioral limitations that may preclude exercise training) for up to 6 months.
  • Patient has a knowledgeable informant who can report the day-to-day activities of participant (e.g., spouse, adult child, paid caregiver).
  • Able to give assent/consent to research study.

Exclusion Criteria:

  • History of learning or developmental disability.
  • Treatment with hormone replacement therapy during the last year.
  • History of psychiatric condition (including depression).
  • Evidence of serious cardiac condition or significant small vessel disease (e.g., heart bypass surgery, angina, arrhythmia, dyspnea, insulin-dependent diabetes with neuropathy, confluent white matter alterations on structural MRI or CT scan).
  • History of neurologic condition (e.g., large vessel stroke, seizures, Parkinsonism).
  • History of heavy metals exposure.
  • History of sleep disturbance (e.g., treated apnea, insomnia).
  • History of brain injury (including concussion of >10 minutes).
  • History of delirium (change in mental status due to medications) for the past year.
  • No pharmaceutical treatment for mood currently, or history of longstanding depression.
Both
65 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00403507
Kelly Garrett
No
Kelly Davis Garrett, PhD, Intermountain Healthcare
Intermountain Health Care, Inc.
Deseret Foundation
Principal Investigator: Kelly Garrett, Ph.D. Intermountain Health Care- LDS Hosptial
Intermountain Health Care, Inc.
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP