Exercise Treatment of Mild-Stage Probable Alzheimer's Disease - Full Text View

Sponsor:	Intermountain Health Care, Inc.
Collaborator:	Deseret Foundation
Information provided by:	Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:	NCT00403507

Purpose

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).

Condition	Intervention	Phase
Alzheimer Disease Memory Disorders Dementia	Behavioral: Participation in a monitored exercise program Behavioral: Personalized aerobic and strength training.	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Exercise and Physical Fitness Memory

U.S. FDA Resources

Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	79
Study Start Date:	October 2006
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Clean Control Probable Alzheimer's disease in the context of no excluding medical conditions.	Behavioral: Participation in a monitored exercise program No contact with control group during 20 weeks.
No Intervention: CoMorbid Control Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.	Behavioral: Participation in a monitored exercise program No contact with control group during 20 weeks.
Experimental: Clean Exercise Probable Alzheimer's disease in the context no comorbid medical conditions.	Behavioral: Personalized aerobic and strength training. Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
Experimental: CoMorbid Exercise Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.	Behavioral: Personalized aerobic and strength training. Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	65 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403507

Locations

United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143

Sponsors and Collaborators

Intermountain Health Care, Inc.

Deseret Foundation

Investigators

Principal Investigator:

Kelly Garrett, Ph.D.

Intermountain Health Care- LDS Hosptial

More Information

No publications provided

Responsible Party:	Kelly Davis Garrett, PhD, Intermountain Healthcare
ClinicalTrials.gov Identifier:	NCT00403507 History of Changes
Other Study ID Numbers:	Kelly Garrett
Study First Received:	November 21, 2006
Last Updated:	May 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:

Mild Dementia
Mild Alzheimer
Cognitive Impairment
Cholinesterase Inhibitor

Exercise
Physical activity
Behavior
Memory loss

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012