Exercise and Insomnia Study: The Effects of 1 Week of Exercise Training on Insomnia Severity

NCT ID: NCT04402021

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2020-12-01

Brief Summary

It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia.

Detailed Description

Limited experimental research has explored the effects of acute exercise training (< 1 week of exercise) on sleep and daytime impairment in samples of adults who meet diagnostic criteria for insomnia. In response to the current literature, the investigators aim to better understand the short-term clinical benefit of adopting exercise training in insomnia. Including multiple bouts of exercise in a short time span while measuring sleep with objective and self-reported measures may be more reflective of capturing true acute effects of exercise implementation on insomnia. The investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. This project will address prior limitations in the area of acute exercise research by utilizing a sample with diagnosed insomnia, assessing multiple nights of sleep, and implementing multiple bouts of exercise stimuli. This project will examine the following aims:

Aim 1: To examine if implementing 1 week of moderate-intensity aerobic exercise improves objective and subjective sleep compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.

Aim 2: To examine if implementing 1 week of moderate-intensity aerobic exercise reduces severity of daytime impairment compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.

Conditions

Insomnia Chronic; Insomnia, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Aerobic Exercise

Participants randomized to the aerobic exercise group will complete 30 minutes of outdoor walking at a moderate intensity, defined as 50% heart rate reserve from the American College of Sports Medicine (ACSM) exercise prescription recommendations. A 5-minute warm-up and cool-down will occur before and after the 30-minute bout. A Polar H10 heart rate monitor will continuously monitor exercise intensity during the session. Ratings of Perceived Exertion (RPE) will be assessed using the Borg scale (i.e., 6-20 rating system) to indicate perceived exercise effort every 5 minutes during the exercise session. Each session will last approximately 50 minutes.

Group Type: EXPERIMENTAL

Outdoor Walking

Intervention Type: BEHAVIORAL

Unsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.

Quiet Rest

Participants randomized to this condition will be instructed to watch a nature documentary void of topics related to sleep or exercise. A Polar H10 heart rate monitor will continuously monitor heart rate during the session to mimic the aerobic exercise condition. Participants will not be permitted to complete homework or work during the allotted time to reduce the chance of unintended stimuli. The quiet rest sessions will be 50 minutes in length.

Group Type: OTHER

Quiet Rest

Intervention Type: OTHER

The quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.

Interventions

Outdoor Walking

Unsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.

Intervention Type: BEHAVIORAL

Quiet Rest

The quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ISI ≥ 10

2. Age 18-55 years

3. Clinically defined Insomnia (i.e., meeting DSM-5 criteria for insomnia disorder)

4. Psychiatric health, aside from treated anxiety and depression determined by participant self-report and instruments described below.

Exclusion Criteria

1. Unstable acute or chronic medical conditions. Examples include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, renal failure, diabetes. Individuals with well-controlled health conditions that do not affect sleep or well-being (e.g., asthma, high blood pressure, diabetes, or ulcers) will not be excluded.

2. Women who are pregnant, nursing, or are planning on becoming pregnant in the next three months.

3. Current untreated major syndromal psychiatric disorders:

Specific exclusionary self-reports include:

• Major depressive disorder
• Dysthymic disorder
• Bipolar disorder
• Panic disorder
• Obsessive compulsive disorder
• Generalized anxiety disorder
• Any psychotic disorder
• Any current substance use disorder

The investigators will NOT exclude participants for:

• Untreated subsyndromal symptoms of depression or anxiety and currently treated and stable depression or anxiety disorder.
• Past episodes of major depressive or anxiety disorder, provided the most recent episode ended at least six months before the diagnostic assessment
• Simple phobia
• Social phobia
• Past eating disorders
• Past substance use disorders
• Specific learning disabilities

4. Other current sleep disorders, such as:

• Insufficient sleep syndrome
• Circadian rhythm sleep disorders
• Narcolepsy
• Restless legs syndrome
• Obstructive sleep apnea
• Current night shift work

Other sleep disorders are diagnosed according to criteria listed in the DSM-5 and the International Classification of Sleep Disorders, 2nd Edition, 2005. These disorders are evaluated using a clinical interview with the Structured Interview for Sleep Disorders.

5. > 0 on the Physical Activity Readiness Questionnaire (PAR-Q+), which represents an inability to safely perform exercise without medical approval or supervision.

6. High risk of sleep-disordered breathing indicated by ≥ 5 'Yes' responses on the STOP-Bang questionnaire, or ≥ 2 + male sex, ≥2 + BMI > 35, or ≥2 + a neck circumference >16 inches (females) or >17 inches (males).

7. Obesity (BMI ≥ 30)

8. Indication of moderate/severe depressive or anxiety symptoms (score ≥ 10 on the Patient Health Questionnaire-9 [PHQ-9] or score ≥ 10 on the 7-item Generalized Anxiety Disorder Questionnaire [GAD-7], respectively)

9. Current treatment for insomnia

10. Suspected circadian rhythm disorder (delayed sleep phase: habitual bedtime ≥ 2:00 am or wake time ≥ 10:00 am; advanced sleep phase: habitual bedtime ≤ 9:00 pm or wake time ≤ 5:00 am)

11. Nocturnal shift-work (i.e., working between 12:00 am and 6:00 am)

12. Physically active (self-report of > 2 sessions/week of structured physical activity or >150 minutes/week of accelerometer-measured bouted moderate to vigorous physical activity)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Andrew Kubala

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Kubala, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY20010197

Identifier Type: -

Identifier Source: org_study_id