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).

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Memory Disorders
• Intervention / Treatment: Behavioral: Participation in a monitored exercise program; Behavioral: Personalized aerobic and strength training.

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).

• Study Type: Interventional
• Enrollment (Anticipated): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 89 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
For the intervention group: Change in cognitive performance relative to baseline	baseline & 20 week follow-up
Group differences in cognitive performance following intervention and relative to wait-list control group	baseline & 20 week follow-up
For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline	baseline & 20 week follow-up
Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group	baseline & 20 week follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes	baseline & 20 week follow-up
Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group	baseline & 20 week follow-up

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Deseret Foundation
• Investigators: Principal Investigator: Kelly Garrett, Ph.D., Intermountain Health Care- LDS Hosptial

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 21, 2006
• First Submitted That Met QC Criteria: November 22, 2006
• First Posted (Estimate): November 23, 2006

Study Record Updates

• Last Update Posted (Estimate): May 11, 2011
• Last Update Submitted That Met QC Criteria: May 9, 2011
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: Exercise; Behavior; Cognitive Impairment; Physical activity; Mild Dementia; Memory loss; Cholinesterase Inhibitor; Mild Alzheimer
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Memory Disorders
• Other Study ID Numbers: Kelly Garrett