- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01329653
Exercise, Age-Related Memory Decline, And Hippocampal Function
24. marts 2020 opdateret af: Richard Sloan, New York State Psychiatric Institute
The purpose of this study is to test the hypothesis that aerobic exercise leads increased cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older adults.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In the US, increased length of life and reduced morbidity and mortality have resulted in a growing number of older adults, the demographic "time bomb" often referred to in discussions of public policy.
According to the Census Bureau, the population aged 65 and over will double in size within the next 25 years.
Moreover, these older adults will live healthier lives than their predecessors.
While this increased length of a healthy life is an undeniable societal benefit, it brings with it a major societal problem: an epidemic of aging-related cognitive decline.
The need to develop interventions to address this growing problem is urgent.
Aging-related cognitive dysfunction is not diffuse; rather it targets selected brain areas, in particular the frontal lobes and the hippocampal formation.
The separate but interconnected subregions of the hippocampus are differentially vulnerable to pathogenic mechanisms, including the normal aging process.
A range of in vivo and post-mortem studies have converged on the dentate gyrus (DG) as the hippocampal subregion differentially targeted by the aging process.
As with pathogenic processes, any intervention that improves brain function does so with regional selectivity.
One such intervention is physical exercise, which has been shown to improve both frontal lobe and hippocampal function.
Using a high-resolution variant of functional magnetic resonance imaging (fMRI), the investigators have demonstrated that aerobic training selectively benefitted DG function both humans and mice.
In addition, improvement in DG function was associated with improved performance on a word list learning task but not in tasks conventionally thought to be frontal lobe dependent.
The human part of the study had significant shortcomings, however: it was small (N = 11), lacked a control group, enrolled only young subjects (age 20-45 years), and employed only a limited neuropsychological testing battery.
The overall goal of this proposal is to use the high-resolution variant of fMRI to test the hypothesis that aerobic training will induce improvements in DG function in a sample of younger (age 20-35) and older (50-65) adults, assigned randomly to an active training condition or wait list control group.
The investigators will use more comprehensive neuropsychological testing to examine the relationship between changes in DG function and selected cognitive capacities.
Taken together with the observation that normal aging differentially targets the DG, this research program will establish that physical exercise is an effective approach for ameliorating the insidious cognitive slide that occurs in aging.
Thus, the potential significance of this application is substantial.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
233
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
-
-
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
20 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 20-75 years
- English-speaking
- Ambulatory
- "Average" fitness as determined by ACSM's Guidelines for Exercise Testing and Prescription (for men, VO2max < 43 for age 20-39 years, < 38 for age 40-49 years, < 35 for age 50-59, < 31 for age 60-75; for women, < 36 for age < 30 years, < 34 for age 30-39 years, < 32 for age 40-49 years, <25 for age 50-59 years, < 24 for age 60-75 years
- BMI <35
Exclusion Criteria:
- Ischemic changes or abnormal resting cardiogram, abnormal blood pressure responses, or an significant ectopy during aerobic capacity testing
- Cardiovascular disease
- BMI > 35
- Uncontrolled high blood pressure (systolic blood pressure ≥ 140 mmHg; or diastolic blood pressure ≥ 90mmHg on two measures)
- Any condition for which aerobic training is counter-indicated, including persons with evidence or history of medical or orthopedic conditions which might make participation problematic.
- Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion.
- Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II). Welltreated hypothyroidism will not be excluded.
- History of chemotherapy
- HIV infection
- Pregnant or lactating (participation allowed 3 months after ceasing lactation).
- Medications that alter inflammation or autonomic nervous system activity
- Any history of psychosis or ECT
- Current or recent (past one year) Major Depressive Disorder, Bipolar Disorder
- Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
- Dementia Rating Scale (DRS) score less than 135. Medical History Interview
- Neurological Disorders Dementia Rating Scale
- Stroke Telephone screen
- Alzheimer's Disease Telephone screen
- Smoking Telephone screen
- Prior participation in another Dr. Sloan Exercise Study
- MRI Exclusion Criteria: Cardiac Pacemaker; Internal Pump; Insulin Pump; Tattoo; eyeliner; Wire Sutures; Internal Metal Objects; Metal Slivers in Eye; Prosthesis; Hearing Aid Implants; Neurostimulator; Metal Fragments; Brain Aneurysm Clips; Vascular Clips; Breast Expander; Vena Cava Filter; Heart Valve; Metal Stents; Asthma; Hay-Fever; Sickle Cell Disease; Kidney Disease; Machinist or ever worked with heavy metals Interview; Contraindication to gadolinium, including prior adverse reaction to gadolinium, past or current history of severe breathing difficulty that has been treated by a physician (e.g., asthma, COPD, etc.), and sickle cell disease. History of renal impairment or estimated glomerular filtration rate <30 L/min/1.73m2 is also exclusionary; Machinist or ever worked with heavy metals Interview; Have had more than one MRI scans with Gadolinium
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: aerobic training
12 weeks of aerobic training, 4X/week
|
12 weeks of aerobic training, 4X/week
|
|
Placebo komparator: wait list control
wait list control condition, 12 weeks to parallel the active intervention group
|
venteliste kontrol tilstand
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
dentate gyrus cerebral blood volume
Tidsramme: change from before (pre) to after (post) 12 weeks of training
|
change from before (pre) to after (post) 12 weeks of training
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cognitive function
Tidsramme: change from before (pre) to after (post) 12 weeks of training
|
measures of memory, executive function, attention/processing speed, language, and general intelligence
|
change from before (pre) to after (post) 12 weeks of training
|
|
aerobic capacity
Tidsramme: change from before (pre) to after (post) 12 weeks of training
|
change from before (pre) to after (post) 12 weeks of training
|
|
|
cerebral blood flow
Tidsramme: change from before (pre) to after (post) 12 weeks of training
|
arterial spin labeling fMRI
|
change from before (pre) to after (post) 12 weeks of training
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 (Faktiske)
1. juni 2011
Primær færdiggørelse (Faktiske)
31. december 2019
Studieafslutning (Faktiske)
31. december 2019
Datoer for studieregistrering
Først indsendt
28. juli 2010
Først indsendt, der opfyldte QC-kriterier
5. april 2011
Først opslået (Skøn)
6. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- #6219/#7161R
- AG035015 (Anden identifikator: CU)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
We will share our data with other investigators upon request.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Venteliste
-
Institute for the Study of Urological Diseases,...Ikke rekrutterer endnuErektil dysfunktion
-
University of Wisconsin, MadisonPatient-Centered Outcomes Research Institute; Brigham and Women's Hospital og andre samarbejdspartnereAfsluttet
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ikke rekrutterer endnuGastroøsofageal refluks | Patient aktiveringForenede Stater
-
Joslin Diabetes CenterBrigham and Women's HospitalAfsluttetKirurgi eller livsstil med intensiv medicinsk behandling i behandling af type 2-diabetes (SLIMM-T2D)Fedme | Type 2 diabetes mellitusForenede Stater
-
Institute for the Study of Urological Diseases,...RekrutteringErektil dysfunktionGrækenland
-
Institute for the Study of Urological Diseases,...AfsluttetErektil dysfunktion | Lav intensitet stødbølgeterapiGrækenland
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Aktiv, ikke rekrutterendeAlzheimers sygdom, tidligt debut | Logopenisk progressiv afasi | Atypisk Alzheimers sygdomForenede Stater
-
Laikο General Hospital, AthensRekrutteringMild autonom kortisolsekretion (MACS)Grækenland
-
St. Jude Children's Research HospitalAktiv, ikke rekrutterendeAkut lymfatisk leukæmi | Executive dysfunktion | Transkraniel jævnstrømsstimuleringForenede Stater
-
Centre Hospitalier Universitaire de Saint EtienneAfsluttetAldring | Psykiatrisk lidelseFrankrig