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Trial record 20 of 45908 for:    intensity

Walking or High Intensity Exercise for Anxiety

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ClinicalTrials.gov Identifier: NCT03819426
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
After an initial phone screen process, approximately 50 participants will be enrolled and evaluated/screened in person after consenting to achieve 30 eligible participants with a principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of either high intensity interval training (HIIT) or walking interventions, which will be completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to identify proportion of individuals opting for each intervention. Results from this pilot study will be used to inform future grant applications including a K award.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Panic Disorder Social Anxiety Behavioral: Low Intensity Exercise Intervention Behavioral: High Intensity Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Walking or High Intensity Exercise for Anxiety
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training
Participants will be shown the appropriate techniques and intensity (high intensity; i.e., 70-90% of maximum heart rate (220-age) with a verified online youtube video. Participants will be provided with this video and other options that can be followed to complete 15 minute HIIT interventions at home. Interventionist will observe participant engaging in HIIT for 15 minutes. HIIT intervention (for 15 minutes) will also be observed during Session 4 and 8.
Behavioral: High Intensity Intervention
Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy

Experimental: Walking
This intervention will be demonstrated during Session 1. Participants will be shown the appropriate walking intensity (low intensity; i.e., approximately 50% of maximum heart rate (220-age) or lower) by interventionist. Interventionist will observe participant engaging in walking at appropriate intensity level for 15 minutes. Walking intervention (for 15 minutes) will also be observed during Session 4 and 8.
Behavioral: Low Intensity Exercise Intervention
Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood




Primary Outcome Measures :
  1. Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF) [ Time Frame: Week 1 ]
    Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.

  2. Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF) [ Time Frame: Week 10 ]
    Scoring involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are stand alone items. The raw score ranges from 14 to 70.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anxiety Sensitivity Index score of ≥20 (i.e., high anxiety sensitivity)
  • Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
  • Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Lifetime history of Bipolar I or II or any psychotic disorder
  • Meets criteria for bulimia or anorexia in the past 6 months
  • Meets criteria for substance use disorder in the past 3 months
  • High current suicide risk as indicated by a score of ≥4 on the C-SSRS
  • Risk for exercise according to Physical Activity Readiness Questionnaire with excluded medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
  • Women who are currently pregnant or plan to become pregnant during the duration of the study
  • Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety or depression (supportive therapy and couples therapy are allowed)
  • Participants on psychiatric medication must be on a stable dose for ≥8 weeks prior to participation
  • Current substance abuse or positive urine toxic screen (recreational use of marijuana is permitted based on clinical assessment on the MINI that it does not meet criteria for cannabis use disorder)

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): NCT03819426


Contacts
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Contact: Bryana Schantz 646-754-3478 Bryana.Schantz@nyulangone.org

Locations
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United States, New York
NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Bryana Schantz    646-754-3478    Bryana.Schantz@nyulangone.org   
Principal Investigator: Naomi Simon, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Naomi Simon, MD NYU Langone

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03819426     History of Changes
Other Study ID Numbers: 18-01277
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Any requests for data will be considered on a case by case basis given the pilot nature of this project. As this is a pilot study, there will not be sufficient data for systematic sharing. Means of participant data will be shared on clinicaltrials.gov.
Time Frame: On a case by case basis, given the pilot nature of this project.
Access Criteria: Requests should be directed to Kristin.szuhany@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Panic Disorder
Pathologic Processes
Mental Disorders