Exercise Treatment of Mild-Stage Probable Alzheimer's Disease
Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease
1 other identifier
interventional
79
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 alzheimer-disease
Started Oct 2006
Typical duration for phase_2 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMay 11, 2011
November 1, 2006
3 years
November 21, 2006
May 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
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
Study Arms (4)
Clean Control
NO INTERVENTIONProbable Alzheimer's disease in the context of no excluding medical conditions.
CoMorbid Control
NO INTERVENTIONProbable Alzheimer's disease in the context of well-controlled comorbid medical conditions.
Clean Exercise
EXPERIMENTALProbable Alzheimer's disease in the context no comorbid medical conditions.
CoMorbid Exercise
EXPERIMENTALProbable Alzheimer's disease in the context of well-controlled comorbid medical conditions.
Interventions
No contact with control group during 20 weeks.
Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intermountain Health Care, Inc.lead
- Deseret Foundationcollaborator
Study Sites (1)
LDS Hospital
Salt Lake City, Utah, 84143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Garrett, Ph.D.
Intermountain Health Care- LDS Hosptial
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 23, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
May 11, 2011
Record last verified: 2006-11