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Clinical Trials/NCT04402021
NCT04402021
Completed
Not Applicable

The Effect of Short-term Exercise on Sleep and Daytime Impairment in Adults With Insomnia

University of Pittsburgh1 site in 1 country24 target enrollmentAugust 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia Chronic
Sponsor
University of Pittsburgh
Enrollment
24
Locations
1
Primary Endpoint
Mean Sleep Efficiency (SE)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 11, 2020
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew Kubala

Principle Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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:
  • Specific exclusionary self-reports include:
  • Major depressive disorder
  • Dysthymic disorder
  • Bipolar disorder
  • Panic disorder
  • Obsessive compulsive disorder
  • Generalized anxiety disorder

Outcomes

Primary Outcomes

Mean Sleep Efficiency (SE)

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

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

PROMIS Sleep Disturbance Questionnaire (PROMIS SD) score

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

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.

Secondary Outcomes

  • 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 Sites (1)

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