Mild Cognitive ImpairmentPACE-2NCT02312843
Piedmont Aging, Cognition & Exercise Study-2
A study testing Exercise/Aerobic and Exercise/Stretching in people with Mild Cognitive Impairment and Prediabetes, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic… Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Prediabetes
- What is being tested?
- Exercise/Aerobic and Exercise/Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 2017
- Phase
- Interventional
- 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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years or older
- Mild memory concerns
- In good health
- Not taking diabetes medications
- Not currently exercising
Who cannot join
- Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness > 30 min or with permanent neurologic sequelae;
- Significant medical illness or organ failure, such as:
- Liver disease: history of hepatitis or hepatic failure
- Significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal
- Kidney disease known history of kidney failure.
- Uncontrolled hypertension
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- 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, is an exclusion. History in the last year of myocardial infarction, angina, coronary artery angioplasty, bypass grafting, pacemaker insertion, STENT placement, postural hypotension, transient ischemic attack, or carotid artery surgery.
- Chronic lung disease, such as: COPD/emphysema
- Hemoglobin A1c levels that fall outside the range of 5.7-6.4%; If 2-h OGTT glucose values 220 mg/dL and hemoglobin A1c levels meet inclusion criteria (5.7-6.4%), then PCP written indication that no pharmacologic intervention for type 2 diabetes is needed at present will be required for continued study participation.
- Current use of anti-psychotic, anti-convulsant, anxiolytic, or sedative medication;
- Current use of any cognition-enhancing medication, including experimental medications within the past 60 days;
- Current or previous use of hypoglycemic agents or insulin (except during pregnacy); diabetics previously on oral agents but have been off of them for > 1 year are ok pending PI and study physician approval.
- Musculoskeletal impairment sufficient to interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Controlled Trial to Examine the Effects of Aerobic Exercise on Cognition and Aging-related Biomarkers for Adults With Prediabetes and Mild Cognitive Impairment
The purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate that exercise improves memory and thinking abilities for adults with mild memory loss OR pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND pre-diabetes.
- Conditions
- Mild Cognitive Impairment, Prediabetes
- Being tested
- Exercise/Aerobic, Exercise/Stretching
- Keywords
- Mild Cognitive Impairment, Cognitive disorders, Prediabetes, Exercise
- Medical subject headings
- Cognitive Dysfunction, Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise/AerobicBehavioural
Exercise/StretchingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Program-aerobic exercises | Active comparator | This exercise program will consist of walking or running on a treadmill or elliptical trainer, or spinning on a stationary bicycle. The goal of the program will be for participants to exercise at a moderate to high level of intensity, defined as 70-80% (American College of Sports Medicine guidelines) of heart rate reserve (HRR), for 45-60 minutes 4 days per week. At the start of each training session and following a 5-minute warm-up, subjects will exercise at 50% HRR (0.5[HRmax-HRrest] +HRrest) and intensity will gradually be increased to the individualized target heart rate training zone. Exercise facilitators will use a pre-specified computerized program. This program provides guidelines for the individualized progression of exercise based on age and resting heart rate. Subjects will wear a digital heart rate monitoring device for the duration of the training session to ensure they are exercising safely at the specified level of intensity. Receives: Behavioral: Exercise/Aerobic |
| Low-intensity Program-Stretching | Placebo comparator | The low-intensity activity program will consist of an individualized and organized series of stretching and balance activities for the whole body, specifically designed for older adults. Consistent with the high-intensity protocol, subjects will complete the prescribed 45-60 minute stretching routine 4 days per week at the exercise facility. All stretching routines will include warm-up and cool-down activities, and will be within each subject's range of motion. Each stretch will be held for 20-30 s and repeated 5-10 times. Subjects will wear a digital heart rate monitoring device to ensure they are stretching safely and at an intensity below 35% HRR. The activity log completed during each stretching session will include HR, stretching duration, and mean HR during stretching. Subjects will also have the option to participate in structured pre-approved (by the exercise facilitator) stretching classes at the exercise facility when available. Receives: Behavioral: Exercise/Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen
The cognitive variables identified above, by domain, will be subjected to separate treatment group X treatment month (3, 6) multivariate analyses of covariance (MANCOVA), with baseline scores and age serving as covariates. When the MANCOVA proves significant, separate post-hoc analysis of covariance (ANCOVA) will be conducted on the relevant dependent variables.
Cognitive tests include measures of executive function and working memory.
Measured: 2 assessments, one before and one after 6 months of exercise
Secondary outcomes (1)
Change from baseline in blood sugar concentration and cerebrospinal fluid glucose measures during an oral glucose tolerance test following 6 months of high or low intensity exercise
Multiple regression and correlational (MRC) analyses will be conducted to evaluate whether treatment-induced change in insulin sensitivity and in other blood and cerebrospinal fluid biomarkers predict cognitive performance among subjects in the aerobic group.
Measured: 3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2017
- Study completionApr 2017
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Laura D. Baker, Ph.D, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312843
- Sponsor's protocol ID
- IRB00022598
- Acronym
- PACE-2
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Examine the Effects of Aerobic Exercise on Cognition and Aging-related Biomarkers for Adults With Prediabetes and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02312843
- Acronym / sponsor ID
- PACE-2 / IRB00022598
- Conditions
- Mild Cognitive Impairment, Prediabetes
- Keywords
- Mild Cognitive Impairment, Cognitive disorders, Prediabetes, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Mar 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Dec 2014 (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 this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate that exercise improves memory and thinking abilities for adults with mild memory loss OR pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND pre-diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Program-aerobic exercises | Active comparator | Behavioral: Exercise/AerobicThis exercise program will consist of walking or running on a treadmill or elliptical trainer, or spinning on a stationary bicycle. The goal of the program will be for participants to exercise at a moderate to high level of intensity, defined as 70-80% (American College of Sports Medicine guidelines) of heart rate reserve (HRR), for 45-60 minutes 4 days per week. At the start of each training session and following a 5-minute warm-up, subjects will exercise at 50% HRR (0.5[HRmax-HRrest] +HRrest) and intensity will gradually be increased to the individualized target heart rate training zone. Exercise facilitators will use a pre-specified computerized program. This program provides guidelines for the individualized progression of exercise based on age and resting heart rate. Subjects will wear a digital heart rate monitoring device for the duration of the training session to ensure they are exercising safely at the specified level of intensity. |
| Low-intensity Program-Stretching | Placebo comparator | Behavioral: Exercise/StretchingThe low-intensity activity program will consist of an individualized and organized series of stretching and balance activities for the whole body, specifically designed for older adults. Consistent with the high-intensity protocol, subjects will complete the prescribed 45-60 minute stretching routine 4 days per week at the exercise facility. All stretching routines will include warm-up and cool-down activities, and will be within each subject's range of motion. Each stretch will be held for 20-30 s and repeated 5-10 times. Subjects will wear a digital heart rate monitoring device to ensure they are stretching safely and at an intensity below 35% HRR. The activity log completed during each stretching session will include HR, stretching duration, and mean HR during stretching. Subjects will also have the option to participate in structured pre-approved (by the exercise facilitator) stretching classes at the exercise facility when available. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years or older
- Mild memory concerns
- In good health
- Not taking diabetes medications
- Not currently exercising
Key exclusion criteria (13 listed)
- Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness > 30 min or with permanent neurologic sequelae;
- Significant medical illness or organ failure, such as:
- Liver disease: history of hepatitis or hepatic failure
- Significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal
- Kidney disease known history of kidney failure.
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 |
|---|---|---|
| Exercise/Aerobic | Behavioural | High-Intensity Program-aerobic exercises |
| Exercise/Stretching | Behavioural | Low-intensity Program-Stretching |
Primary outcome
Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen
Time frame: 2 assessments, one before and one after 6 months of exercise
The cognitive variables identified above, by domain, will be subjected to separate treatment group X treatment month (3, 6) multivariate analyses of covariance (MANCOVA), with baseline scores and age serving as covariates. When the MANCOVA proves significant, separate post-hoc analysis of covariance (ANCOVA) will be conducted on the relevant dependent variables. Cognitive tests include measures of executive function and working memory.
1 secondary outcome
Change from baseline in blood sugar concentration and cerebrospinal fluid glucose measures during an oral glucose tolerance test following 6 months of high or low intensity exercise
Time frame: 3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen
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 15 Aug 2018.
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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, Ph.D principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise/Aerobic and Exercise/Stretching in people with Mild Cognitive Impairment and Prediabetes, run by Wake Forest University 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 5 inclusion and 13 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 15 Aug 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 performance from baseline following 6 month of high or low intensity exercise regimen (time frame: 2 assessments, one before and one after 6 months of exercise). 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 15 Aug 2018.