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

NCT04402021 | Completed

• 1 other identifier: STUDY20010197
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Insomnia, Primary

Outcome Measures

Primary Outcomes (2)

• Mean Sleep Efficiency (SE)

  Mean SE derived from wrist-worn actigraphy (7 nights of data)

  Change in SE between baseline and intervention week (approx. 2 weeks)

• PROMIS Sleep Disturbance Questionnaire (PROMIS SD) score

  A 5-point Likert scale composed of eight items rated from 1 (not at all, very poor, or never) to 5 (very much, always, or very good) with four items reversed scored. Total raw scores range from 8 to 40 with higher scores indicating greater disturbance. Raw scores will be converted to corresponding T-scores using a published data conversion table.

  Change in PROMIS SD between baseline and intervention week (approx. 2 weeks)

Secondary Outcomes (2)

• Insomnia Severity Index (ISI) score

  Change in ISI between baseline and intervention week (approx. 2 weeks)

• PROMIS Sleep Related Impairment Questionnaire (PROMIS SRI) score

  Change in PROMIS SRI between baseline and intervention week (approx. 2 weeks)

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: Outdoor Walking

Quiet Rest

OTHER

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.

Other: Quiet Rest

Interventions

Outdoor Walking 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.

Aerobic Exercise

Quiet Rest 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.

Quiet Rest

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ISI ≥ 10
• Age 18-55 years
• Clinically defined Insomnia (i.e., meeting DSM-5 criteria for insomnia disorder)
• Psychiatric health, aside from treated anxiety and depression determined by participant self-report and instruments described below.

You may not qualify if:

• 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.
• Women who are pregnant, nursing, or are planning on becoming pregnant in the next three months.
• Current untreated major syndromal psychiatric disorders:
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Andrew Kubala, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 26, 2020
• Study Start: August 11, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 1 year following peer-reviewed publication of research questions outlined in grant and ending 5 years following publication of study results.
• Access Criteria: Data access will be provided to external researchers who provide a methodologically sound proposal for secondary data analysis that is approved by the investigators of the study. Proposals should be directed to the study PI.

Locations

US (1)