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Walking or High Intensity Exercise for Anxiety

Primary Purpose

Generalized Anxiety Disorder, Panic Disorder, Social Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low Intensity Exercise Intervention

High Intensity Intervention

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

NYU Langone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High Intensity Interval Training

Walking

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

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.

Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03819426

First Posted

October 29, 2018

Last Updated

September 25, 2020

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03819426

Brief Title

Walking or High Intensity Exercise for Anxiety

Official Title

Walking or High Intensity Exercise for Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 11, 2018 (Actual)

Primary Completion Date

July 29, 2020 (Actual)

Study Completion Date

July 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder, Panic Disorder, Social Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Interval Training

Arm Type

Experimental

Arm Description

Arm Title

Walking

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Low Intensity Exercise Intervention

Intervention Description

Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood

Intervention Type

Behavioral

Intervention Name(s)

High Intensity Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

Description

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.

Time Frame

Week 1

Title

Efficacy of HIIT measured by Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q-SF)

Description

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.

Time Frame

Week 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin Szuhany, PhD

Organizational Affiliation

NYU Langone

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

On a case by case basis, given the pilot nature of this project.

IPD Sharing Access Criteria

Requests should be directed to Kristin.szuhany@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Walking or High Intensity Exercise for Anxiety

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