- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01329653
Exercise, Age-Related Memory Decline, And Hippocampal Function
24. mars 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
233
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: aerobic training
12 weeks of aerobic training, 4X/week
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12 weeks of aerobic training, 4X/week
|
|
Placebo komparator: wait list control
wait list control condition, 12 weeks to parallel the active intervention group
|
kontrolltilstand på venteliste
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
dentate gyrus cerebral blood volume
Tidsramme: change from before (pre) to after (post) 12 weeks of training
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change from before (pre) to after (post) 12 weeks of training
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2011
Primær fullføring (Faktiske)
31. desember 2019
Studiet fullført (Faktiske)
31. desember 2019
Datoer for studieregistrering
Først innsendt
28. juli 2010
Først innsendt som oppfylte QC-kriteriene
5. april 2011
Først lagt ut (Anslag)
6. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- #6219/#7161R
- AG035015 (Annen identifikator: CU)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
We will share our data with other investigators upon request.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .