Clinical trial NCT03759509: Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile
Official title: Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse
Attention
Aerobic Exercise
Sleep Quality
Fatigue
Cortisol
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will randomly sample from previously screen low sleep quality participants, then random assign to experimental (aerobic exercise) and control (routine activity) groups
Primary purpose: OTHER

Brief summary: Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality. The study is conducted a prospective parallel randomized trial is performed to 60 nurses with low sleep quality. The subjects are randomly assigned to: (i) the experimental group, in which aerobic exercise training is given; (ii) the control group, in which the subjects kept their original lifestyles. The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile.

Detailed description: When work shifts and lifestyles change, the synchronous relationship between the body's biological clock and the environment, i.e., circadian rhythms, is disrupted, resulting in insufficient sleep and insomnia. Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement often come with increased fatigue, which contributes to a high risk of accident and patient safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality, whereas few researchers have argued over how aerobic exercise training improves sleep quality in nurses. The study is conducted in two stages. Previous stage, we conducted with a cross-sectional study design with convenience sampled 200 participants to fill out the Chinese Pittsburgh Sleep Quality Index (CPSQI) questionnaire for screen the low sleep quality (CPSQI \> 5) participants. A total of 200 nurses were recruited, and 199 valid samples were collected, 108 participants were found to have low sleep quality (CPSQI \> 5). The study will adopt a prospective, longitudinal, parallel-group comparative study, randomly sample from previously screen low sleep quality participants, then random assign to experimental (aerobic exercise) and control (routine activity) groups, and actigraphy sleep recording, saliva samples and attention data will be collected.

The study aims to investigate the effects of aerobic exercise training on nurses' sleep quality, fatigue, attention and cortisol profile. The findings of the study could provide guidelines on improving nurses' fitness and sleep quality.

Eligibility criteria: Inclusion Criteria:

* Full-time
* Female nursing staff members
* Worked 8 hours per shift
* Had at least 1 year of work experience.

Exclusion Criteria:

* Had used sedatives, hypnotics, antihistamines, or hormonal drugs within the 4 weeks before commencing the study
* Pregnant
* Were diagnosed as having sleep or stress disorders, or experienced sleep problems owing to concurrent insomnia or sleep apnea.

Primary outcomes:
measure: Total sleep time sleep change
timeFrame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
measure: Wake after sleep onset change
timeFrame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
measure: Sleep efficiency change
timeFrame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
measure: Seep onset latency change
timeFrame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Secondary outcomes:
measure: Simple visual reaction time testing
timeFrame: Before and after work, the test are completed within 5 min
measure: Saliva cortisol
timeFrame: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: shu fen Niu, PhD
role: PRINCIPAL_INVESTIGATOR
References: