AnxietyNCT03036371
Pilot Study of the Impact of Exercise on Hippocampal Function
A study testing High Intensity Interval Exercise in people with Anxiety, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anxiety
- What is being tested?
- High Intensity Interval Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Pilot Study of the Impact of Exercise on Hippocampal Behavior
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- High Intensity Interval Exercise
- Keywords
- Neurogenesis, Memory, Spatial Processing, Hippocampus, Cognition, Aerobic Exercise
- Medical subject headings
- Anxiety Disorders, Spatial Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval ExerciseBehavioural
6 week at-home aerobic exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Exercise | Experimental | home exercise sessions Receives: Behavioral: High Intensity Interval Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Correct Score for the Treasure Hunt Task (THT)
change between baseline and 6 weeks
Measured: 6 weeks
Secondary outcomes (4)
Change in Percent Correct Score for the Mnemonic Similarity Test (MST)
change between baseline and 6 weeks
Measured: 6 weeks
Change in Depression, Anxiety, and Stress Scale (DASS)
change in self-report questionnaire score between baseline and 6 weeks
Measured: 6 weeks
Change in Intolerance of Uncertainty Scale (IUS)
change in self-report questionnaire score between baseline and 6 weeks
Measured: 6 weeks
Change in Baecke Physical Activity Questionnaire
change in self-report questionnaire score between baseline and 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start28 Mar 2017
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Helen Blair Simpson, New York State Psychiatric Institute
- Investigators
- Helen B Simpson, M.D, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036371
- Sponsor's protocol ID
- 7418
- Status last verified
- Mar 2019
- First submitted
- 3 Jan 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Impact of Exercise on Hippocampal Behavior
- ClinicalTrials.gov ID
- NCT03036371
- Acronym / sponsor ID
- 7418
- Conditions
- Anxiety
- Keywords
- Neurogenesis, Memory, Spatial Processing, Hippocampus, Cognition, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Exercise | Experimental | Behavioral: High Intensity Interval Exercisehome exercise sessions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Exercise6 week at-home aerobic exercise protocol | Behavioural | High Intensity Interval Exercise |
Primary outcome
Change in Percent Correct Score for the Treasure Hunt Task (THT)
Time frame: 6 weeks
change between baseline and 6 weeks
4 secondary outcomes
Change in Percent Correct Score for the Mnemonic Similarity Test (MST)
Time frame: 6 weeks
Change in Depression, Anxiety, and Stress Scale (DASS)
Time frame: 6 weeks
Change in Intolerance of Uncertainty Scale (IUS)
Time frame: 6 weeks
Change in Baecke Physical Activity Questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No. 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.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen B Simpson, M.D, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Exercise in people with Anxiety, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Correct Score for the Treasure Hunt Task (THT) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.