Pilot Study of the Impact of Exercise on Hippocampal Function

NCT ID: NCT03036371

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2018-09-13

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Intensity Interval Exercise

home exercise sessions

Group Type EXPERIMENTAL

High Intensity Interval Exercise

Intervention Type BEHAVIORAL

6 week at-home aerobic exercise protocol

Interventions

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High Intensity Interval Exercise

6 week at-home aerobic exercise protocol

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Helen Blair Simpson

Professor of Clinical Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen B Simpson, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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7418

Identifier Type: -

Identifier Source: org_study_id

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