Mild Cognitive ImpairmentPhase 2NCT00220467
Cognitive Effects of Aerobic Exercise for MCI Adults
A Phase 2 study testing Aerobic exercise in people with Mild Cognitive Impairment, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.
Trial summary
The specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to May 2008
- 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with mild cognitive impairment, at least 55 years of age, sedentary (elevated HR \& SOB <3x/wk and <30min on each occasion), overall good general health, willing to exercise at least 4 times/wk for 6 months
Who cannot join
- Significant neurologic disease that might affect cognition, such as a diagnosis of Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness; significant medical illness or organ failure such as liver disease, significant elevations in liver function tests, kidney disease, uncontrolled hypertension (BP>140/90 on medication); cardiovascular disease defined as any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema; chronic lung disease, or musculoskeletal impairment (impaired walking); current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative, or any cognition-enhancing medications; current or previous use of hypoglycemic agents or insulin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108
Veterans Affairs Puget Sound Health Care System
Tacoma, Washington, 98493
About this study
Official title: Cognitive Effects of Aerobic Exercise for Adults With Mild Cognitive Impairment: A Controlled Trial
The specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.
Read the detailed description
The specific aims for the study are 1) to determine if aerobic exercise enhances cognition for older adults with mild cognitive impairment, 2) to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects in the aerobic exercise group, and 3) to relate exercise effects on insulin sensitivity and cognition to growth factor expression, inflammatory markers, catecholamines, beta-amyloid, and body-fat composition. Using a randomized controlled parallel group design, 40 sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity (via hyperinsulinemic-euglycemic clamp), maximum aerobic capacity (via respiratory gas exchange and cardiopulmonary fitness measures), and body fat composition (via DEXA scan) and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Aerobic exercise
- Keywords
- MCI, aging, cognition, exercise, aerobic, insulin
- Medical subject headings
- Cognitive Dysfunction, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive scores
Change in insulin sensitivity
Secondary outcomes (2)
Change in biomarkers associated with Alzheimer's disease progression
Correlation between cognitive scores, insulin sensitivity, & biomarkers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Investigators
- Laura D Baker, PhD, Principal investigator, VA Puget Sound Health Care System; University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220467
- Sponsor's protocol ID
- RDIS 0008
- Other IDs
- ALZ ASSOC BL18 (SIBCR)
- Status last verified
- Jul 2008
- First submitted
- 21 Sep 2005
- Last updated
- 30 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Aerobic Exercise for Adults With Mild Cognitive Impairment: A Controlled Trial
- ClinicalTrials.gov ID
- NCT00220467
- Acronym / sponsor ID
- RDIS 0008
- Conditions
- Mild Cognitive Impairment
- Keywords
- MCI, aging, cognition, exercise, aerobic, insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Jan 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Sep 2005 (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 specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at greater risk for developing Alzheimer's disease, and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.
Detailed description
The specific aims for the study are 1) to determine if aerobic exercise enhances cognition for older adults with mild cognitive impairment, 2) to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects in the aerobic exercise group, and 3) to relate exercise effects on insulin sensitivity and cognition to growth factor expression, inflammatory markers, catecholamines, beta-amyloid, and body-fat composition. Using a randomized controlled parallel group design, 40 sedentary older adults diagnosed with mild cognitive impairment will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity (via hyperinsulinemic-euglycemic clamp), maximum aerobic capacity (via respiratory gas exchange and cardiopulmonary fitness measures), and body fat composition (via DEXA scan) and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline for older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with mild cognitive impairment, at least 55 years of age, sedentary (elevated HR \& SOB <3x/wk and <30min on each occasion), overall good general health, willing to exercise at least 4 times/wk for 6 months
Key exclusion criteria (1 listed)
- Significant neurologic disease that might affect cognition, such as a diagnosis of Alzheimer's disease, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness; significant medical illness or organ failure such as liver disease, significant elevations in liver function tests, kidney disease, uncontrolled hypertension (BP>140/90 on medication); cardiovascular disease defined as any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema; chronic lung disease, or musculoskeletal impairment (impaired walking); current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative, or any cognition-enhancing medications; current or previous use of hypoglycemic agents or insulin.
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 |
|---|---|---|
| Aerobic exercise | Behavioural | – |
Primary outcome
Change in cognitive scores
Change in insulin sensitivity
2 secondary outcomes
Change in biomarkers associated with Alzheimer's disease progression
Correlation between cognitive scores, insulin sensitivity, & biomarkers
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 30 Jul 2008.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Laura D Baker, PhD principal investigator
VA Puget Sound Health Care System; University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise in people with Mild Cognitive Impairment, run by Seattle Institute for Biomedical and Clinical Research at 2 sites 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 1 inclusion and 1 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 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in cognitive scores. The study lists 2 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 30 Jul 2008.