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Completed

NCT Number: NCT03036371

Pilot Study of the Impact of Exercise on Hippocampal Function

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Spatial Behavior Spatial Processing

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Exercise

Behavioral

6 week at-home aerobic exercise protocol

Primary outcomes

  1. Change in Percent Correct Score for the Treasure Hunt Task (THT)

    Time frame: 6 weeks

    change between baseline and 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University

Registry information

Official study title

Pilot Study of the Impact of Exercise on Hippocampal Behavior

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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