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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03759509
Other study ID # TMU-JIRBN201711007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date October 1, 2019

Study information

Verified date November 2018
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total sleep time sleep change The actigraphy reported on sleep parameters of the amount of actual sleep minutes The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Primary Wake after sleep onset change The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time. The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Primary Sleep efficiency change The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on. The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Primary Seep onset latency change The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode. The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Secondary Simple visual reaction time testing Psychomotor Vigilance Task Monitor to test simple visual reaction time Before and after work, the test are completed within 5 min
Secondary Saliva cortisol Diurnal cortisol concentration Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
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