NCT01329653

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

8.6 years

First QC Date

July 28, 2010

Last Update Submit

March 24, 2020

Conditions

Keywords

cerebral blood volumeagingexercise

Outcome Measures

Primary Outcomes (1)

  • dentate gyrus cerebral blood volume

    change from before (pre) to after (post) 12 weeks of training

Secondary Outcomes (3)

  • cognitive function

    change from before (pre) to after (post) 12 weeks of training

  • aerobic capacity

    change from before (pre) to after (post) 12 weeks of training

  • cerebral blood flow

    change from before (pre) to after (post) 12 weeks of training

Study Arms (2)

aerobic training

EXPERIMENTAL

12 weeks of aerobic training, 4X/week

Behavioral: aerobic training

wait list control

PLACEBO COMPARATOR

wait list control condition, 12 weeks to parallel the active intervention group

Behavioral: Wait list

Interventions

12 weeks of aerobic training, 4X/week

aerobic training
Wait listBEHAVIORAL

wait list control condition

Also known as: Wait list control
wait list control

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Pereira AC, Huddleston DE, Brickman AM, Sosunov AA, Hen R, McKhann GM, Sloan R, Gage FH, Brown TR, Small SA. An in vivo correlate of exercise-induced neurogenesis in the adult dentate gyrus. Proc Natl Acad Sci U S A. 2007 Mar 27;104(13):5638-43. doi: 10.1073/pnas.0611721104. Epub 2007 Mar 20.

MeSH Terms

Conditions

Motor Activity

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Richard P Sloan, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 28, 2010

First Posted

April 6, 2011

Study Start

June 1, 2011

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

We will share our data with other investigators upon request.

Locations