Alzheimer DiseasePhase 2NCT00403507
Exercise Treatment of Mild-Stage Probable Alzheimer's Disease
A Phase 2 study testing Participation in a monitored exercise program and Personalized aerobic and strength training. in people with Alzheimer Disease and Memory Disorders, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Alzheimer Disease, Memory Disorders, Dementia
- What is being tested?
- Participation in a monitored exercise program and Personalized aerobic and strength training.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Alzheimer Disease, Memory Disorders, Dementia
- Being tested
- Participation in a monitored exercise program, Personalized aerobic and strength training.
- Keywords
- Mild Dementia, Mild Alzheimer, Cognitive Impairment, Cholinesterase Inhibitor, Exercise, Physical activity, Behavior, Memory loss
- Medical subject headings
- Alzheimer Disease, Memory Disorders, Dementia, Cognitive Dysfunction, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in a monitored exercise programBehavioural
No contact with control group during 20 weeks.
Personalized aerobic and strength training.Behavioural
Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.
| Study group | Role | What they receive |
|---|---|---|
| Clean Control | No intervention | Probable Alzheimer's disease in the context of no excluding medical conditions. Receives: Behavioral: Participation in a monitored exercise program |
| CoMorbid Control | No intervention | Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions. Receives: Behavioral: Participation in a monitored exercise program |
| Clean Exercise | Experimental | Probable Alzheimer's disease in the context no comorbid medical conditions. Receives: Behavioral: Personalized aerobic and strength training. |
| CoMorbid Exercise | Experimental | Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions. Receives: Behavioral: Personalized aerobic and strength training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
For the intervention group: Change in cognitive performance relative to baseline
Measured: baseline & 20 week follow-up
Group differences in cognitive performance following intervention and relative to wait-list control group
Measured: baseline & 20 week follow-up
For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline
Measured: baseline & 20 week follow-up
Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group
Measured: baseline & 20 week follow-up
Secondary outcomes (2)
For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes
Measured: 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
Measured: baseline & 20 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Investigators
- Kelly Garrett, Ph.D., Principal investigator, Intermountain Health Care- LDS Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403507
- Sponsor's protocol ID
- Kelly Garrett
- Status last verified
- Nov 2006
- First submitted
- 21 Nov 2006
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity as a Treatment of Mild-Stage Probable Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00403507
- Acronym / sponsor ID
- Kelly Garrett
- Conditions
- Alzheimer Disease, Memory Disorders, Dementia
- Keywords
- Mild Dementia, Mild Alzheimer, Cognitive Impairment, Cholinesterase Inhibitor, Exercise, Physical activity, Behavior, Memory loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- Oct 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clean Control | No intervention | Behavioral: Participation in a monitored exercise programProbable Alzheimer's disease in the context of no excluding medical conditions. |
| CoMorbid Control | No intervention | Behavioral: Participation in a monitored exercise programProbable Alzheimer's disease in the context of well-controlled comorbid medical conditions. |
| Clean Exercise | Experimental | Behavioral: Personalized aerobic and strength training.Probable Alzheimer's disease in the context no comorbid medical conditions. |
| CoMorbid Exercise | Experimental | Behavioral: Personalized aerobic and strength training.Probable Alzheimer's disease in the context of well-controlled comorbid medical conditions. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in a monitored exercise programNo contact with control group during 20 weeks. | Behavioural | Clean Control, CoMorbid Control |
| Personalized aerobic and strength training.Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist. | Behavioural | Clean Exercise, CoMorbid Exercise |
Primary outcome
For the intervention group: Change in cognitive performance relative to baseline
Time frame: baseline & 20 week follow-up
Group differences in cognitive performance following intervention and relative to wait-list control group
Time frame: baseline & 20 week follow-up
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
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
2 secondary outcomes
For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes
Time frame: 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
Time frame: baseline & 20 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Garrett, Ph.D. principal investigator
Intermountain Health Care- LDS Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Participation in a monitored exercise program and Personalized aerobic and strength training. in people with Alzheimer Disease and Memory Disorders, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For the intervention group: Change in cognitive performance relative to baseline (time frame: baseline & 20 week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.