NurseNCT03759509
Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile
A study testing aerobic exercise in people with Nurse and Attention, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurse, Attention, Aerobic Exercise
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time
- Female nursing staff members
- Worked 8 hours per shift
- Had at least 1 year of work experience.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Nurse, Attention, Aerobic Exercise, Sleep Quality, Fatigue, Cortisol
- Being tested
- aerobic exercise
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise training | Experimental | three times a week, a total of twenty-four times in eight weeks Receives: Behavioral: aerobic exercise |
| control | No intervention | routine activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time sleep change
The actigraphy reported on sleep parameters of the amount of actual sleep minutes
Measured: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Wake after sleep onset change
The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.
Measured: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Sleep efficiency change
The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.
Measured: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Seep onset latency change
The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.
Measured: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
Secondary outcomes (2)
Simple visual reaction time testing
Psychomotor Vigilance Task Monitor to test simple visual reaction time
Measured: Before and after work, the test are completed within 5 min
Saliva cortisol
Diurnal cortisol concentration
Measured: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NurseStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shu fen Niu, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759509
- Sponsor's protocol ID
- TMU-JIRBN201711007
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03759509
- Acronym / sponsor ID
- TMU-JIRBN201711007
- Conditions
- Nurse, Attention, Aerobic Exercise, Sleep Quality, Fatigue, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise training | Experimental | Behavioral: aerobic exercisethree times a week, a total of twenty-four times in eight weeks |
| control | No intervention | –routine activity |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full-time
- Female nursing staff members
- Worked 8 hours per shift
- Had at least 1 year of work experience.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercisethe experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks | Behavioural | aerobic exercise training |
Primary outcome
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
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.
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.
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.
2 secondary outcomes
Simple visual reaction time testing
Time frame: Before and after work, the test are completed within 5 min
Saliva cortisol
Time frame: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shu fen Niu, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Nurse and Attention, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep time sleep change (time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.