<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759509</url>
  </required_header>
  <id_info>
    <org_study_id>TMU-JIRBN201711007</org_study_id>
    <nct_id>NCT03759509</nct_id>
  </id_info>
  <brief_title>Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile</brief_title>
  <official_title>Effects of Aerobic Exercise Training on Nurses' Sleep Quality, Fatigue, Attention and Cortisol Profile: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shift work in nursing has been found to result in sleep disruption and sleep deprivation, and&#xD;
      in sleepiness or fatigue at work. Slow reaction, insufficient attention and poor judgement&#xD;
      often come with increased fatigue, which contributes to a high risk of accident and patient&#xD;
      safety. Studies have shown that aerobic exercise is helpful in promoting high sleep quality.&#xD;
      The study is conducted a prospective parallel randomized trial is performed to 60 nurses with&#xD;
      low sleep quality. The subjects are randomly assigned to: (i) the experimental group, in&#xD;
      which aerobic exercise training is given; (ii) the control group, in which the subjects kept&#xD;
      their original lifestyles. The study aims to investigate the effects of aerobic exercise&#xD;
      training on nurses' sleep quality, fatigue, attention and cortisol profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When work shifts and lifestyles change, the synchronous relationship between the body's&#xD;
      biological clock and the environment, i.e., circadian rhythms, is disrupted, resulting in&#xD;
      insufficient sleep and insomnia. Shift work in nursing has been found to result in sleep&#xD;
      disruption and sleep deprivation, and in sleepiness or fatigue at work. Slow reaction,&#xD;
      insufficient attention and poor judgement often come with increased fatigue, which&#xD;
      contributes to a high risk of accident and patient safety. Studies have shown that aerobic&#xD;
      exercise is helpful in promoting high sleep quality, whereas few researchers have argued over&#xD;
      how aerobic exercise training improves sleep quality in nurses. The study is conducted in two&#xD;
      stages. Previous stage, we conducted with a cross-sectional study design with convenience&#xD;
      sampled 200 participants to fill out the Chinese Pittsburgh Sleep Quality Index (CPSQI)&#xD;
      questionnaire for screen the low sleep quality (CPSQI &gt; 5) participants. A total of 200&#xD;
      nurses were recruited, and 199 valid samples were collected, 108 participants were found to&#xD;
      have low sleep quality (CPSQI &gt; 5). The study will adopt a prospective, longitudinal,&#xD;
      parallel-group comparative study, randomly sample from previously screen low sleep quality&#xD;
      participants, then random assign to experimental (aerobic exercise) and control (routine&#xD;
      activity) groups, and actigraphy sleep recording, saliva samples and attention data will be&#xD;
      collected.&#xD;
&#xD;
      The study aims to investigate the effects of aerobic exercise training on nurses' sleep&#xD;
      quality, fatigue, attention and cortisol profile. The findings of the study could provide&#xD;
      guidelines on improving nurses' fitness and sleep quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total sleep time sleep change</measure>
    <time_frame>The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week</time_frame>
    <description>The actigraphy reported on sleep parameters of the amount of actual sleep minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wake after sleep onset change</measure>
    <time_frame>The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week</time_frame>
    <description>The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep efficiency change</measure>
    <time_frame>The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week</time_frame>
    <description>The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seep onset latency change</measure>
    <time_frame>The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week</time_frame>
    <description>The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Simple visual reaction time testing</measure>
    <time_frame>Before and after work, the test are completed within 5 min</time_frame>
    <description>Psychomotor Vigilance Task Monitor to test simple visual reaction time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva cortisol</measure>
    <time_frame>Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening</time_frame>
    <description>Diurnal cortisol concentration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nurse</condition>
  <condition>Attention</condition>
  <condition>Aerobic Exercise</condition>
  <condition>Sleep Quality</condition>
  <condition>Fatigue</condition>
  <condition>Cortisol</condition>
  <arm_group>
    <arm_group_label>aerobic exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>three times a week, a total of twenty-four times in eight weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>routine activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>aerobic exercise</intervention_name>
    <description>the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks</description>
    <arm_group_label>aerobic exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full-time&#xD;
&#xD;
          -  Female nursing staff members&#xD;
&#xD;
          -  Worked 8 hours per shift&#xD;
&#xD;
          -  Had at least 1 year of work experience.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had used sedatives, hypnotics, antihistamines, or hormonal drugs within the 4 weeks&#xD;
             before commencing the study&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Were diagnosed as having sleep or stress disorders, or experienced sleep problems&#xD;
             owing to concurrent insomnia or sleep apnea.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shu fen Niu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Medical University</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759509
org study id: TMU-JIRBN201711007
nct id: NCT03759509
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Total sleep time sleep change
time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
description: The actigraphy reported on sleep parameters of the amount of actual sleep minutes
measure: Wake after sleep onset change
time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
description: The actigraphy reported on the amount of minutes they were awake between sleep onset and wake time.
measure: Sleep efficiency change
time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
description: The actigraphy reported on sleep parameters of percentage of time asleep while in bed from lights off to lights on.
measure: Seep onset latency change
time frame: The 1st workday 8:00AM to 5th workday 8:00AM of 4th, 8th, and 12th week
description: The actigraphy reported on sleep parameters of the minutes between lights off and first sleep episode.
measure: Simple visual reaction time testing
time frame: Before and after work, the test are completed within 5 min
description: Psychomotor Vigilance Task Monitor to test simple visual reaction time
measure: Saliva cortisol
time frame: Collected at awakening [0 min] and at 30 min, 6 hours, and 12 hours after awakening
description: Diurnal cortisol concentration
arm group label: aerobic exercise training
arm group type: Experimental
description: three times a week, a total of twenty-four times in eight weeks
arm group label: control
arm group type: No Intervention
description: routine activity
intervention type: Behavioral
intervention name: aerobic exercise
description: the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks
arm group label: aerobic exercise training
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: shu fen Niu, PhD
role: Principal Investigator
affiliation: Taipei Medical University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Fatigue
sharing ipd: No