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Completed

NCT Number: NCT03759509

Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile

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.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks

Primary outcomes

  1. Total sleep time sleep change

    Time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

    The actigraphy reported on sleep parameters of the amount of actual sleep minutes

  2. Wake after sleep onset change

    Time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

    The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.

  3. Sleep efficiency change

    Time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

    The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.

  4. Seep onset latency change

    Time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week

    The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.

Secondary outcomes

  1. Simple visual reaction time testing

    Time frame: Before and after work, the test are completed within 5 min

    Psychomotor Vigilance Task Monitor to test simple visual reaction time

  2. Saliva cortisol

    Time frame: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening

    Diurnal cortisol concentration

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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