Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile
Primary Purpose
Nurse, Attention, Aerobic Exercise
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
About this trial
This is an interventional other trial for Nurse
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
aerobic exercise training
control
Arm Description
three times a week, a total of twenty-four times in eight weeks
routine activity
Outcomes
Primary Outcome Measures
Total sleep time sleep change
The actigraphy reported on sleep parameters of the amount of actual sleep minutes
Wake after sleep onset change
The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.
Sleep efficiency change
The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.
Seep onset latency change
The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.
Secondary Outcome Measures
Simple visual reaction time testing
Psychomotor Vigilance Task Monitor to test simple visual reaction time
Saliva cortisol
Diurnal cortisol concentration
Full Information
NCT ID
NCT03759509
First Posted
November 27, 2018
Last Updated
October 7, 2020
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03759509
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse, Attention, Aerobic Exercise, Sleep Quality, Fatigue, Cortisol
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise training
Arm Type
Experimental
Arm Description
three times a week, a total of twenty-four times in eight weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
routine activity
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise
Intervention Description
the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks
Primary Outcome Measure Information:
Title
Total sleep time sleep change
Description
The actigraphy reported on sleep parameters of the amount of actual sleep minutes
Time Frame
The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Title
Wake after sleep onset change
Description
The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.
Time Frame
The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Title
Sleep efficiency change
Description
The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.
Time Frame
The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Title
Seep onset latency change
Description
The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.
Time Frame
The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Secondary Outcome Measure Information:
Title
Simple visual reaction time testing
Description
Psychomotor Vigilance Task Monitor to test simple visual reaction time
Time Frame
Before and after work, the test are completed within 5 min
Title
Saliva cortisol
Description
Diurnal cortisol concentration
Time Frame
Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shu fen Niu, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile
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