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- Essai clinique NCT01329653
Exercise, Age-Related Memory Decline, And Hippocampal Function
24 mars 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
233
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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New York, New York, États-Unis, 10032
- Columbia University Medical Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: aerobic training
12 weeks of aerobic training, 4X/week
|
12 weeks of aerobic training, 4X/week
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|
Comparateur placebo: wait list control
wait list control condition, 12 weeks to parallel the active intervention group
|
condition de contrôle de la liste d'attente
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
dentate gyrus cerebral blood volume
Délai: change from before (pre) to after (post) 12 weeks of training
|
change from before (pre) to after (post) 12 weeks of training
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
cognitive function
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2011
Achèvement primaire (Réel)
31 décembre 2019
Achèvement de l'étude (Réel)
31 décembre 2019
Dates d'inscription aux études
Première soumission
28 juillet 2010
Première soumission répondant aux critères de contrôle qualité
5 avril 2011
Première publication (Estimation)
6 avril 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mars 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mars 2020
Dernière vérification
1 mars 2020
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- #6219/#7161R
- AG035015 (Autre identifiant: CU)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
We will share our data with other investigators upon request.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .