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Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

Primary Purpose

Alzheimer Disease, Memory Disorders, Dementia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Participation in a monitored exercise program

Personalized aerobic and strength training.

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Mild Dementia, Mild Alzheimer, Cognitive Impairment, Cholinesterase Inhibitor, Exercise, Physical activity, Behavior, Memory loss

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

LDS Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Clean Control

CoMorbid Control

Clean Exercise

CoMorbid Exercise

Arm Description

Probable Alzheimer's disease in the context of no excluding medical conditions.

Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.

Probable Alzheimer's disease in the context no comorbid medical conditions.

Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00403507

First Posted

November 21, 2006

Last Updated

May 9, 2011

Sponsor

Intermountain Health Care, Inc.

Collaborators

Deseret Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00403507

Brief Title

Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

Official Title

Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Intermountain Health Care, Inc.

Collaborators

Deseret Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Memory Disorders, Dementia

Keywords

Mild Dementia, Mild Alzheimer, Cognitive Impairment, Cholinesterase Inhibitor, Exercise, Physical activity, Behavior, Memory loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clean Control

Arm Type

No Intervention

Arm Description

Probable Alzheimer's disease in the context of no excluding medical conditions.

Arm Title

CoMorbid Control

Arm Type

No Intervention

Arm Description

Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.

Arm Title

Clean Exercise

Arm Type

Experimental

Arm Description

Probable Alzheimer's disease in the context no comorbid medical conditions.

Arm Title

CoMorbid Exercise

Arm Type

Experimental

Arm Description

Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions.

Intervention Type

Behavioral

Intervention Name(s)

Participation in a monitored exercise program

Intervention Description

No contact with control group during 20 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Personalized aerobic and strength training.

Intervention Description

Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.

Primary Outcome Measure Information:

Title

For the intervention group: Change in cognitive performance relative to baseline

Time Frame

baseline & 20 week follow-up

Title

Group differences in cognitive performance following intervention and relative to wait-list control group

Time Frame

baseline & 20 week follow-up

Title

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

Title

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

Secondary Outcome Measure Information:

Title

For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes

Time Frame

baseline & 20 week follow-up

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly Garrett, Ph.D.

Organizational Affiliation

Intermountain Health Care- LDS Hosptial

Official's Role

Principal Investigator

Facility Information:

Facility Name

LDS Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84143

Country

United States

12. IPD Sharing Statement

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Exercise Treatment of Mild-Stage Probable Alzheimer's Disease

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