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Pilot Study of the Impact of Exercise on Hippocampal Function

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ClinicalTrials.gov Identifier: NCT03036371
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Helen Blair Simpson, New York State Psychiatric Institute

Brief Summary:
The goal of this pilot study is to test the procedural aspects of the behavioral tests and the exercise components of the study. This includes establishing typical scores for anxiety patients in these behavioral tests, and administering and coaching anxiety patients in an at-home exercise regimen. This pilot study will produce the information necessary to design a larger future study including both patients and healthy control participants.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: High Intensity Interval Exercise Not Applicable

Detailed Description:

This is a pilot study to explore whether High Intensity Interval Training (HIIT) aerobic exercise can improve performance on hippocampal dependent behaviors or anxiety measures . HIIT is a form of interval training that alternates short periods of high effort exercise with less intense recovery periods. Participants in this study will undertake a 6-week protocol of HIIT exercise, performed at home on a portable stepper device. Outcome measures for this study will be performance on two hippocampus-dependent behaviors and responses to mood and anxiety questionnaires.

The hippocampus is a brain structure that is involved in learning and memory, and is one of the two sites of adult neurogenesis, the process of generating of new neurons from stem cells in the adult mammalian brain. Adult neurogenesis may represent a new target for the treatment of anxiety disorders. The tests in this study consist of a picture-based memory task and a location memory task. Eligible participants will complete both game tasks. In each test, participants will sit in front of a computer and play these games using the computer keyboard or a handheld video game controller.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Impact of Exercise on Hippocampal Behavior
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Exercise
home exercise sessions
Behavioral: High Intensity Interval Exercise
6 week at-home aerobic exercise protocol




Primary Outcome Measures :
  1. Change in Percent Correct Score for the Treasure Hunt Task (THT) [ Time Frame: 6 weeks ]
    change between baseline and 6 weeks


Secondary Outcome Measures :
  1. Change in Percent Correct Score for the Mnemonic Similarity Test (MST) [ Time Frame: 6 weeks ]
    change between baseline and 6 weeks

  2. Change in Depression, Anxiety, and Stress Scale (DASS) [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks

  3. Change in Intolerance of Uncertainty Scale (IUS) [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks

  4. Change in Baecke Physical Activity Questionnaire [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary diagnosis of Obsessive Compulsive Disorder (OCD), Social Anxiety Disorder (SAD), Generalized Anxiety Disorder (GAD), Panic Disorder (PD), and/or Specific Phobia (SP)
  • No use of psychiatric medication in the past 4 weeks (or 8 weeks for fluoxetine)
  • Age 18-40
  • Ability to tolerate a treatment-free period
  • English-speaking
  • Body Mass Index (BMI) within normal range
  • Willing and able to sign consent form and comply with study procedures

Exclusion Criteria:

  • Current or lifetime comorbid psychiatric conditions that significantly elevate the risk of study participation
  • Any major medical or neurological problem that might interfere with reliable performance of study tasks or their interpretation, or render participation dangerous
  • Pregnant or lactating
  • Use of medication that alters the brain
  • Clinical symptom severity warranting immediate treatment
  • Current rigorous exercise program
  • Participation in Cognitive Behavioral Therapy (CBT) psychotherapy for anxiety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036371


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
Investigators
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Principal Investigator: Helen B Simpson, M.D, Ph.D. New York State Psychiatric Institute

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Responsible Party: Helen Blair Simpson, Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03036371     History of Changes
Other Study ID Numbers: 7418
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot study intended to assess the feasibility of an at-home exercise protocol in a patient population, and to measure within-patient changes from baseline to post-exercise in order to calculate sample sizes needed for a full study. Therefore, the investigators do not plan to share the data of this small pilot study with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helen Blair Simpson, New York State Psychiatric Institute:
Neurogenesis
Memory
Spatial Processing
Hippocampus
Cognition
Aerobic Exercise