University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
NCT Number: NCT04402021
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15260, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific exclusionary self-reports include:
The investigators will NOT exclude participants for:
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.
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.
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.
Time frame: Change in SE between baseline and intervention week (approx. 2 weeks)
Mean SE derived from wrist-worn actigraphy (7 nights of data)
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.
Time frame: Change in ISI between baseline and intervention week (approx. 2 weeks)
A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
Time frame: Change in PROMIS SRI between baseline and intervention week (approx. 2 weeks)
A 5-point Likert scale composed of 8 items rated from 1 (not at all) to 5 (very much). One of the eight items (I felt alert when I woke up) is reverse scored. A total score from 8 to 40 is computed with higher scores indicating worse impairment. 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.
University of Pittsburgh
Other
The Effect of Short-term Exercise on Sleep and Daytime Impairment in Adults With Insomnia
Acronym: Insomni-Ex
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