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Pilot Study of the Impact of Exercise on Hippocampal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date March 27, 2019
Actual Study Start Date  ICMJE March 28, 2017
Actual Primary Completion Date September 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Change in Percent Correct Score for the Treasure Hunt Task (THT) [ Time Frame: 6 weeks ]
change between baseline and 6 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Change in Percent Correct Score for the Mnemonic Similarity Test (MST) [ Time Frame: 6 weeks ]
    change between baseline and 6 weeks
  • Change in Depression, Anxiety, and Stress Scale (DASS) [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks
  • Change in Intolerance of Uncertainty Scale (IUS) [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks
  • Change in Baecke Physical Activity Questionnaire [ Time Frame: 6 weeks ]
    change in self-report questionnaire score between baseline and 6 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of the Impact of Exercise on Hippocampal Function
Official Title  ICMJE Pilot Study of the Impact of Exercise on Hippocampal Behavior
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE Behavioral: High Intensity Interval Exercise
6 week at-home aerobic exercise protocol
Study Arms  ICMJE Experimental: High Intensity Interval Exercise
home exercise sessions
Intervention: Behavioral: High Intensity Interval Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
30
Actual Study Completion Date  ICMJE September 13, 2018
Actual Primary Completion Date September 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036371
Other Study ID Numbers  ICMJE 7418
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Helen Blair Simpson, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Columbia University
Investigators  ICMJE
Principal Investigator: Helen B Simpson, M.D, Ph.D. New York State Psychiatric Institute
PRS Account New York State Psychiatric Institute
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP