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Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

Primary Purpose

Traumatic Stress Disorder, Post Traumatic Stress Disorder, Trauma and Stressor Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training (HIIT)
Waitlist
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Stress Disorder

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • self-reported exposure to a traumatic event
  • persistent (> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
  • poor sleep quality (Pittsburgh Sleep Quality Index >5)
  • failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (<150-mins of moderate or 75-mins of vigorous physical activity [or a combination] per week and/or < 2 days a week of resistance training targeting the major muscle groups).
  • able to safely perform high-intensity exercise
  • aged 18-39 years
  • non-smoker
  • willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab
  • willing to avoid caffeine for 12 hours before visiting the lab

Exclusion Criteria:

  • Pregnant, lactating, or plans to become pregnant over the next 2 months.
  • Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
  • Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
  • History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
  • Pain intensity of 8 or greater in the thigh or foot in the past month
  • Probable alcohol use disorder

Sites / Locations

  • University of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High Intensity Interval Training (HIIT)

Waitlist Control

Arm Description

High-intensity interval training will be performed three times a week for a total of six weeks.

Waitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group.

Outcomes

Primary Outcome Measures

Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.
Heart Rate Variability
High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.
State Trait Anxiety Inventory (STAI-Y2)
The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.
The Posttraumatic Diagnostic Scale-5 (PDS-5)
The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
April 15, 2023
Sponsor
University of Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT05097352
Brief Title
Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Official Title
Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.
Detailed Description
A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Stress Disorder, Post Traumatic Stress Disorder, Trauma and Stressor Related Disorders, Mental Disorders, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training (HIIT)
Arm Type
Experimental
Arm Description
High-intensity interval training will be performed three times a week for a total of six weeks.
Arm Title
Waitlist Control
Arm Type
Sham Comparator
Arm Description
Waitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training (HIIT)
Intervention Description
Twenty minutes of HIIT will be completed three days a week for six weeks.
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
Waitlist participants will be tested on the outcomes at the same time points as the treatment group.
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index (PSQI)
Description
The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.
Time Frame
Change from Baseline to week 7
Title
Heart Rate Variability
Description
High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.
Time Frame
Change from Baseline to Week 7
Title
State Trait Anxiety Inventory (STAI-Y2)
Description
The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.
Time Frame
Change from Baseline to Week 7
Title
The Posttraumatic Diagnostic Scale-5 (PDS-5)
Description
The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.
Time Frame
Change from Baseline to Week 7

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: self-reported exposure to a traumatic event persistent (> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional. poor sleep quality (Pittsburgh Sleep Quality Index >5) failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (<150-mins of moderate or 75-mins of vigorous physical activity [or a combination] per week and/or < 2 days a week of resistance training targeting the major muscle groups). able to safely perform high-intensity exercise aged 18-39 years non-smoker willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab willing to avoid caffeine for 12 hours before visiting the lab Exclusion Criteria: Pregnant, lactating, or plans to become pregnant over the next 2 months. Individuals who started taking medication for anxiety or depression-related symptoms within the last month. Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate. History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma). Pain intensity of 8 or greater in the thigh or foot in the past month Probable alcohol use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J O'Connor, PhD
Organizational Affiliation
University of Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

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