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

Sponsor

University of Georgia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05097352

Collaborator

(none)

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Stress Disorder Post Traumatic Stress Disorder Trauma and Stressor Related Disorders Mental Disorders Exercise	Behavioral: High Intensity Interval Training (HIIT) Other: Waitlist	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

Actual Study Start Date :

Jan 24, 2022

Anticipated Primary Completion Date :

Oct 28, 2022

Anticipated Study Completion Date :

Oct 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Intensity Interval Training (HIIT) High-intensity interval training will be performed three times a week for a total of six weeks.	Behavioral: High Intensity Interval Training (HIIT) Twenty minutes of HIIT will be completed three days a week for six weeks.
Sham Comparator: Waitlist Control 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.	Other: Waitlist Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

Arm

Intervention/Treatment

Experimental: High Intensity Interval Training (HIIT)

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

Behavioral: High Intensity Interval Training (HIIT)

Twenty minutes of HIIT will be completed three days a week for six weeks.

Sham Comparator: Waitlist Control

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.

Other: Waitlist

Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

Outcome Measures

Primary Outcome Measures

Pittsburg Sleep Quality Index (PSQI) [Change from Baseline to week 7]
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 [Change from Baseline to Week 7]
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) [Change from Baseline to Week 7]
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) [Change from Baseline to Week 7]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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