Piedmont Aging, Cognition & Exercise Study-2 (PACE-2)
13. august 2018 opdateret af: Wake Forest University
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Baptist Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 89 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 50 years or older
- Mild memory concerns
- In good health
- Not taking diabetes medications
- Not currently exercising
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: High-Intensity Program-aerobic exercises
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.
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Placebo komparator: Low-intensity Program-Stretching
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen
Tidsramme: 2 assessments, one before and one after 6 months of exercise
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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. |
2 assessments, one before and one after 6 months of exercise
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
Tidsramme: 3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen
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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.
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3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in brain network connectivity using brain imaging
Tidsramme: 2 brain scans over a 6 month period, one before and one after the 6 month exercise regimen
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Whole-brain averages will be computed, reflecting characteristics of the entire system.
Whole-brain averages will be compared with random networks generated with the same node number and degree,48 and will be compared between intervention groups using general linear regression models.
Regions of interest (hippocampus, posterior cingulate/precuneus, prefrontal cortex) will be extracted using WFU Pickatlas and regional degree, Eglob, or Eloc will be compared between groups using the general linear model.
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2 brain scans over a 6 month period, one before and one after the 6 month exercise regimen
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Laura D. Baker, Ph.D, Wake Forest University Health Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2013
Primær færdiggørelse (Faktiske)
1. april 2017
Studieafslutning (Faktiske)
1. april 2017
Datoer for studieregistrering
Først indsendt
3. oktober 2014
Først indsendt, der opfyldte QC-kriterier
5. december 2014
Først opslået (Skøn)
9. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00022598
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