xml: <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/NCT05966805</url>
    </required_header>
    <id_info>
      <org_study_id>1762353</org_study_id>
      <nct_id>NCT05966805</nct_id>
    </id_info>
    <brief_title>Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses</brief_title>
    <acronym>WELL_NURSE</acronym>
    <official_title>Examining the Impact of a 12-week Worksite Exercise Training Intervention on Mental, Metabolic, Physical, Spiritual, and Occupational Well-being Among Acute Care Nurses: A Randomized, Controlled Mixed Methods Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AdventHealth</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AdventHealth</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>
        This is a randomized, wait-list control pilot study to analyze the impact of a 12-week&#xD;
        exercise training intervention on post-traumatic growth and whole-person well-being (mental&#xD;
        health, physical health, spiritual well-being, perceived social support, and occupational&#xD;
        health) among shift-working acute care nurses within AdventHealth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study has five phases: Phase I: Screening; Phase II: Baseline Assessments&#xD;
        (Pre-Intervention); Phase III: Exercise training; Phase IV: Post-Intervention; and Phase V:&#xD;
        Repeat assessments at 3-months and 6-months post-intervention.&#xD;
  &#xD;
        Phase I (90 minutes): This phase consists of reviewing and obtaining consent, screening for&#xD;
        inclusion/exclusion criteria, reviewing study details, and assessing the need for medical&#xD;
        clearance to participate in the exercise intervention, and a single blood draw for fasted&#xD;
        blood profiles.&#xD;
  &#xD;
        Phase II (7 hours): Upon successful screening, all participants will complete baseline&#xD;
        assessments.&#xD;
  &#xD;
        Phase III (Exercise Training Group 34 hours/Wait-List Control 4.5 hours): Upon completion of&#xD;
        Phase II, participants will be randomized to the exercise training intervention group or the&#xD;
        wait-list control group.&#xD;
  &#xD;
        Phase IV (7 hours): All participants will enter a post-intervention phase that includes&#xD;
        repeat assessments of Phase II outcomes.&#xD;
  &#xD;
        Phase V (~2 hours): A subset of psychometric questionnaires will be repeated 3- and 6-months&#xD;
        post-exercise training intervention to ascertain sustainability of the intervention.&#xD;
  &#xD;
        *Subjects randomized to the wait-list control group will be offered the exercise training&#xD;
        intervention upon completion of the Phase V assessments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Post-traumatic growth</measure>
      <time_frame>Group comparison baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Post-traumatic growth inventory (PTGI) (21-item questionnaire with Likert scale of 0-5, with 0 for &quot;I did not experience this change as a result of my crisis&quot; and 5 for &quot;I experienced this change to a very great degree as a result of my crisis&quot;)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Patient Health Questionnaire (PHQ-2) (2-items measuring depression using Likert scale of 0 to 3 with 0 for &quot;not at all&quot; and 3 for &quot;nearly every day)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Generalized Anxiety Disorder Scale (GAD-2) (2-items measuring anxiety with 4-point Likert scale with 0 for &quot;not at all&quot; and 3 for &quot;nearly every day&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Professional Quality of Life for Health care workers</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Professional Quality of Life Health (Pro-QOL Health) (30-items covering five domains (6 items each domain): 1) Compassion Satisfaction, 2) Perceived Support, 3) Burnout, 4) Secondary Traumatic Stress, and 5) Moral Distress using a Likert scale of 1-5 with 1 for &quot;never&quot; and 5 for &quot;very often&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiorespiratory fitness</measure>
      <time_frame>Group comparisons baseline, 3 months follow-up</time_frame>
      <description>Cardiopulmonary exercise test (CPX-T). (Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle test)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>24-H Physical activity patterns</measure>
      <time_frame>Group comparisons baseline, 3 months follow-up</time_frame>
      <description>GT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer to estimate the energy cost of free-living activity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spiritual well-being</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>FACIT Spiritual Well-Being (FACIT-Sp) Non-Illness Version (12-items with a 5-point Likert with total score range from 0-32 with higher scores indicating better QOL/spiritual well-being)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Job Satisfaction</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Nurse Job Satisfaction Scale (7 items using a 5-point Likert scale from 1 for &quot;strongly disagree&quot; to 5 for &quot;strongly agree&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Missed Care</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>NDNQI Index of Work Satisfaction missed care (Two multiple choice questions about the last shift worked)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work-related exhaustion</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Quality Work Competence (3-item subscale with 5-point Likert scale from 1 for &quot;never&quot; to 5 for &quot;very often&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Errors</measure>
      <time_frame>Group comparisons baseline, 3 months, and 6 months follow-up</time_frame>
      <description>Single-item medical error question.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>Group comparisons baseline, week 12</time_frame>
      <description>GT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer sleep measurements to determine total sleep time, sleep efficiency, and sleep latency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep questionnaire</measure>
      <time_frame>Group comparisons baseline, week 12</time_frame>
      <description>Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep diary</measure>
      <time_frame>Group comparisons baseline, week 12</time_frame>
      <description>National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Health</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Workplace Cognitive Failure Scale (15 items about experiences during last work week with Likert scale from 1 for &quot;never&quot; to 5 for &quot;very often&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Blood collection fasting glucose, fasting insulin, lipid panel profile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up</time_frame>
      <description>Weight in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up</time_frame>
      <description>Waist circumference in centimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up</time_frame>
      <description>Calculated body mass index based on current weight in kilograms and height in centimeters taken at baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>DEXA scan</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Diet history Questionnaire-III (DHQ-III) (A questionnaire on beverage and food intake over the past month with branching items on amount of consumption based on responses)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical condition - strength</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>International Physical Activity Questionnaire (IPAQ) (27 maximum branching items with 5 parts: 1) Job-related physical activity, 2) Transportation physical activity, 3) Housework, house maintenance, and caring for family, 4) Recreation, sport, and leisure-time physical activity, 5) Time spent sitting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lifestyle Beliefs</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Healthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from &quot;Strongly Disagree&quot; to &quot;Strongly Agree&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lifestyle Behaviors</measure>
      <time_frame>Group comparison baseline, 1 week follow-up</time_frame>
      <description>Healthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from &quot;Strongly Disagree&quot; to &quot;Strongly Agree&quot;</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adherence/Compliance</measure>
      <time_frame>1 week follow-up</time_frame>
      <description>Percentage of exercise session attendance (number of attended sessions/the number of scheduled sessions)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Psychological Wellness</condition>
    <arm_group>
      <arm_group_label>Exercise Training Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise intervention group will undergo a 12-week exercise program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-List Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Wait-List control group will participate in visits every 4 weeks for data collection and periodic phone calls for monitoring. They will be offered the exercise training intervention option at conclusion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise training group</intervention_name>
      <description>12-Week Exercise intervention on mentaL, metabolic, physicaL, spiritual, social, and occupational well-being among shift-working acute care NURSE</description>
      <arm_group_label>Exercise Training Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Wait-List Control Group</intervention_name>
      <description>Control group</description>
      <arm_group_label>Wait-List Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion:&#xD;
  &#xD;
            1. Age 21-65 years&#xD;
  &#xD;
            2. Nurse working in an AdventHealth inpatient acute care setting&#xD;
  &#xD;
            3. Currently working as a shift-working acute care nurse within AdventHealth.&#xD;
  &#xD;
            4. Weight stable prior to beginning the study exercise training intervention.&#xD;
  &#xD;
            5. Able to speak and understand written and spoken English.&#xD;
  &#xD;
            6. Understands the procedures and agrees to participate by giving written informed&#xD;
               consent.&#xD;
  &#xD;
            7. Willing and able to comply with scheduled visits, laboratory tests, and other study&#xD;
               procedures including a 12-week exercise training program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Positive urine pregnancy test prior to DEXA scan&#xD;
  &#xD;
            2. Uncontrolled Type 1 or Type 2 diabetes mellitus&#xD;
  &#xD;
            3. Bleeding disorders&#xD;
  &#xD;
            4. Acute or chronic infections&#xD;
  &#xD;
            5. Chronic obstructive pulmonary disease&#xD;
  &#xD;
            6. Renal insufficiency or nephritis&#xD;
  &#xD;
            7. Uncontrolled hypertension (BP&gt;160 mmHg systolic or &gt;100 mmHg diastolic)&#xD;
  &#xD;
            8. History of Cushing's disease or syndrome&#xD;
  &#xD;
            9. Active rheumatoid arthritis or other inflammatory rheumatic disorder&#xD;
  &#xD;
           10. Major surgery within 4 weeks prior to Screening&#xD;
  &#xD;
           11. Participation in studies involving investigational drug(s) within 30 days prior to&#xD;
               Screening&#xD;
  &#xD;
           12. History or presence of cardiovascular disease (unstable angina, myocardial infarction&#xD;
               or coronary revascularization within 6 months, presence of cardiac pacemaker,&#xD;
               implanted cardiac defibrillator)&#xD;
  &#xD;
           13. Any malignancy not considered cured, except basal cell carcinoma and squamous cell&#xD;
               carcinoma of the skin (a participant is considered cured if there has been no evidence&#xD;
               of cancer recurrence in the previous 5 years)&#xD;
  &#xD;
           14. Presence of any condition that, in the opinion of the Investigator or medical&#xD;
               investigator, compromises participant safety or data integrity or the participant's&#xD;
               ability to complete study days.&#xD;
  &#xD;
           15. More than 1-day a week of intentional exercise&#xD;
  &#xD;
           16. Medically diagnosed sleep disorder&#xD;
  &#xD;
           17. Weight &gt;450 lbs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeanette Green, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>AdventHealth</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeanette Green, PhD</last_name>
      <phone>407-200-2901</phone>
      <email>jeanette.green@adventhealth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andrea Brennan, PhD</last_name>
      <phone>407-200-2901</phone>
      <email>andrea.brennan@adventhealth.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.</citation>
      <PMID>25030030</PMID>
    </reference>
    <reference>
      <citation>Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.</citation>
      <PMID>25576495</PMID>
    </reference>
    <reference>
      <citation>Vetter C, Devore EE, Wegrzyn LR, Massa J, Speizer FE, Kawachi I, Rosner B, Stampfer MJ, Schernhammer ES. Association Between Rotating Night Shift Work and Risk of Coronary Heart Disease Among Women. JAMA. 2016 Apr 26;315(16):1726-34. doi: 10.1001/jama.2016.4454.</citation>
      <PMID>27115377</PMID>
    </reference>
    <reference>
      <citation>Brown JP, Martin D, Nagaria Z, Verceles AC, Jobe SL, Wickwire EM. Mental Health Consequences of Shift Work: An Updated Review. Curr Psychiatry Rep. 2020 Jan 18;22(2):7. doi: 10.1007/s11920-020-1131-z.</citation>
      <PMID>31955278</PMID>
    </reference>
    <reference>
      <citation>Torquati L, Mielke GI, Brown WJ, Burton NW, Kolbe-Alexander TL. Shift Work and Poor Mental Health: A Meta-Analysis of Longitudinal Studies. Am J Public Health. 2019 Nov;109(11):e13-e20. doi: 10.2105/AJPH.2019.305278. Epub 2019 Sep 19.</citation>
      <PMID>31536404</PMID>
    </reference>
    <reference>
      <citation>American Nurses Association. Healthy Nurse Healthy Nation: Year Three Highlights 2019-2020, &lt;https://www.healthynursehealthynation.org/globalassets/all-images-view-with-media/about/2020-hnhn_sup-8.pdf&gt; (2020)</citation>
    </reference>
    <reference>
      <citation>Chellappa SL, Morris CJ, Scheer FAJL. Circadian misalignment increases mood vulnerability in simulated shift work. Sci Rep. 2020 Oct 29;10(1):18614. doi: 10.1038/s41598-020-75245-9.</citation>
      <PMID>33122670</PMID>
    </reference>
    <reference>
      <citation>Scheer FAJL, Chellappa SL, Hu K, Shea SA. Impact of mental stress, the circadian system and their interaction on human cardiovascular function. Psychoneuroendocrinology. 2019 May;103:125-129. doi: 10.1016/j.psyneuen.2019.01.016. Epub 2019 Jan 16.</citation>
      <PMID>30682628</PMID>
    </reference>
    <reference>
      <citation>Sletten TL, Cappuccio FP, Davidson AJ, Van Cauter E, Rajaratnam SMW, Scheer FAJL. Health consequences of circadian disruption. Sleep. 2020 Jan 13;43(1):zsz194. doi: 10.1093/sleep/zsz194. No abstract available.</citation>
      <PMID>31930347</PMID>
    </reference>
    <reference>
      <citation>Vetter C, Scheer FAJL. A healthy lifestyle - reducing T2DM risk in shift workers? Nat Rev Endocrinol. 2019 Apr;15(4):194-196. doi: 10.1038/s41574-019-0164-z. No abstract available.</citation>
      <PMID>30718862</PMID>
    </reference>
    <reference>
      <citation>McHill AW, Melanson EL, Higgins J, Connick E, Moehlman TM, Stothard ER, Wright KP Jr. Impact of circadian misalignment on energy metabolism during simulated nightshift work. Proc Natl Acad Sci U S A. 2014 Dec 2;111(48):17302-7. doi: 10.1073/pnas.1412021111. Epub 2014 Nov 17.</citation>
      <PMID>25404342</PMID>
    </reference>
    <reference>
      <citation>Stuijfzand S, Deforges C, Sandoz V, Sajin CT, Jaques C, Elmers J, Horsch A. Psychological impact of an epidemic/pandemic on the mental health of healthcare professionals: a rapid review. BMC Public Health. 2020 Aug 12;20(1):1230. doi: 10.1186/s12889-020-09322-z.</citation>
      <PMID>32787815</PMID>
    </reference>
    <reference>
      <citation>Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016 Jul 8;11(7):e0159015. doi: 10.1371/journal.pone.0159015. eCollection 2016.</citation>
      <PMID>27391946</PMID>
    </reference>
    <reference>
      <citation>Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.</citation>
      <PMID>26606383</PMID>
    </reference>
    <reference>
      <citation>Melnyk BM, Kelly SA, Stephens J, Dhakal K, McGovern C, Tucker S, Hoying J, McRae K, Ault S, Spurlock E, Bird SB. Interventions to Improve Mental Health, Well-Being, Physical Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review. Am J Health Promot. 2020 Nov;34(8):929-941. doi: 10.1177/0890117120920451. Epub 2020 Apr 27.</citation>
      <PMID>32338522</PMID>
    </reference>
    <reference>
      <citation>Bischoff LL, Otto AK, Hold C, Wollesen B. The effect of physical activity interventions on occupational stress for health personnel: A systematic review. Int J Nurs Stud. 2019 Sep;97:94-104. doi: 10.1016/j.ijnurstu.2019.06.002. Epub 2019 Jun 11.</citation>
      <PMID>31234106</PMID>
    </reference>
    <reference>
      <citation>Chappel SE, Verswijveren SJJM, Aisbett B, Considine J, Ridgers ND. Nurses' occupational physical activity levels: A systematic review. Int J Nurs Stud. 2017 Aug;73:52-62. doi: 10.1016/j.ijnurstu.2017.05.006. Epub 2017 May 10.</citation>
      <PMID>28535398</PMID>
    </reference>
    <reference>
      <citation>Chen, J. et al. Physical activity and post-traumatic growth: A systematic review of quantitative and qualitative studies. Psychology of Sport &amp; Exercise 49, doi:10.1016/j.psychsport.2020.101679 (2020).</citation>
    </reference>
    <reference>
      <citation>Constandt B, Thibaut E, De Bosscher V, Scheerder J, Ricour M, Willem A. Exercising in Times of Lockdown: An Analysis of the Impact of COVID-19 on Levels and Patterns of Exercise among Adults in Belgium. Int J Environ Res Public Health. 2020 Jun 10;17(11):4144. doi: 10.3390/ijerph17114144.</citation>
      <PMID>32532013</PMID>
    </reference>
    <reference>
      <citation>Coulson, J. C., McKenna, J. &amp; Field, M. Exercising at work and self-reported work performance. International Journal of Workplace Health Management 1, 176-197, doi:10/1108/17538350810926534 (2008).</citation>
    </reference>
    <reference>
      <citation>Doran K, Resnick B, Alghzawi H, Zhu S. The worksite heart health improvement project's impact on behavioral risk factors for cardiovascular disease in long-term care: A randomized control trial. Int J Nurs Stud. 2018 Oct;86:107-114. doi: 10.1016/j.ijnurstu.2018.06.011. Epub 2018 Jun 28.</citation>
      <PMID>30005312</PMID>
    </reference>
    <reference>
      <citation>Jakobsen MD, Sundstrup E, Brandt M, Andersen LL. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial. BMC Public Health. 2017 Oct 10;17(1):798. doi: 10.1186/s12889-017-4728-3.</citation>
      <PMID>29017479</PMID>
    </reference>
    <reference>
      <citation>Matsugaki R, Kuhara S, Saeki S, Jiang Y, Michishita R, Ohta M, Yamato H. Effectiveness of workplace exercise supervised by a physical therapist among nurses conducting shift work: A randomized controlled trial. J Occup Health. 2017 Jul 27;59(4):327-335. doi: 10.1539/joh.16-0125-OA. Epub 2017 Jun 20.</citation>
      <PMID>28638000</PMID>
    </reference>
    <reference>
      <citation>Ochentel O, Humphrey C, Pfeifer K. Efficacy of Exercise Therapy in Persons with Burnout. A Systematic Review and Meta-Analysis. J Sports Sci Med. 2018 Aug 14;17(3):475-484. eCollection 2018 Sep.</citation>
      <PMID>30116121</PMID>
    </reference>
    <reference>
      <citation>Tucker S, Farrington M, Lanningham-Foster LM, Clark MK, Dawson C, Quinn GJ, Laffoon T, Perkhounkova Y. Worksite Physical Activity Intervention for Ambulatory Clinic Nursing Staff. Workplace Health Saf. 2016 Jul;64(7):313-25. doi: 10.1177/2165079916633225. Epub 2016 May 3.</citation>
      <PMID>27143144</PMID>
    </reference>
    <reference>
      <citation>White MI, Dionne CE, Warje O, Koehoorn M, Wagner SL, Schultz IZ, Koehn C, Williams-Whitt K, Harder HG, Pasca R, Hsu V, McGuire L, Schulz W, Kube D, Wright MD. Physical Activity and Exercise Interventions in the Workplace Impacting Work Outcomes: A Stakeholder-Centered Best Evidence Synthesis of Systematic Reviews. Int J Occup Environ Med. 2016 Apr;7(2):61-74. doi: 10.15171/ijoem.2016.739.</citation>
      <PMID>27112715</PMID>
    </reference>
    <reference>
      <citation>Bridgland VME, Moeck EK, Green DM, Swain TL, Nayda DM, Matson LA, Hutchison NP, Takarangi MKT. Why the COVID-19 pandemic is a traumatic stressor. PLoS One. 2021 Jan 11;16(1):e0240146. doi: 10.1371/journal.pone.0240146. eCollection 2021.</citation>
      <PMID>33428630</PMID>
    </reference>
    <reference>
      <citation>Marcomini I, Agus C, Milani L, Sfogliarini R, Bona A, Castagna M. COVID-19 and post-traumatic stress disorder among nurses: a descriptive cross-sectional study in a COVID hospital. Med Lav. 2021 Jun 15;112(3):241-249. doi: 10.23749/mdl.v112i3.11129.</citation>
      <PMID>34142675</PMID>
    </reference>
    <reference>
      <citation>Tedeschi, R. G. &amp; Calhoun, L. G. Posttraumatic growth: Conceptual foundations and empirical evidence. Psychological Inquiry 15, 1-18 (2004).</citation>
    </reference>
    <reference>
      <citation>National Center for Complementary and Integrative Health. (National Center for Complementary and Integrative Health, 2021).</citation>
    </reference>
    <reference>
      <citation>U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd edition edn, (Department of Health and Human Services, 2018).</citation>
    </reference>
    <reference>
      <citation>Linke SE, Gallo LC, Norman GJ. Attrition and adherence rates of sustained vs. intermittent exercise interventions. Ann Behav Med. 2011 Oct;42(2):197-209. doi: 10.1007/s12160-011-9279-8.</citation>
      <PMID>21604068</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>exercise</keyword>
    <keyword>whole person health</keyword>
    <keyword>nurses</keyword>
    <keyword>pilot study</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966805
  org study id: 1762353
  nct id: NCT05966805
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, wait-list control pilot study to analyze the impact of a 12-week
        exercise training intervention on post-traumatic growth and whole-person well-being (mental
        health, physical health, spiritual well-being, perceived social support, and occupational
        health) among shift-working acute care nurses within AdventHealth.
  This study has five phases: Phase I: Screening; Phase II: Baseline Assessments
        (Pre-Intervention); Phase III: Exercise training; Phase IV: Post-Intervention; and Phase V:
        Repeat assessments at 3-months and 6-months post-intervention.
  
        Phase I (90 minutes): This phase consists of reviewing and obtaining consent, screening for
        inclusion/exclusion criteria, reviewing study details, and assessing the need for medical
        clearance to participate in the exercise intervention, and a single blood draw for fasted
        blood profiles.
  
        Phase II (7 hours): Upon successful screening, all participants will complete baseline
        assessments.
  
        Phase III (Exercise Training Group 34 hours/Wait-List Control 4.5 hours): Upon completion of
        Phase II, participants will be randomized to the exercise training intervention group or the
        wait-list control group.
  
        Phase IV (7 hours): All participants will enter a post-intervention phase that includes
        repeat assessments of Phase II outcomes.
  
        Phase V (~2 hours): A subset of psychometric questionnaires will be repeated 3- and 6-months
        post-exercise training intervention to ascertain sustainability of the intervention.
  
        *Subjects randomized to the wait-list control group will be offered the exercise training
        intervention upon completion of the Phase V assessments.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Post-traumatic growth
  time frame: Group comparison baseline, 3 months, and 6 months follow-up
  description: Post-traumatic growth inventory (PTGI) (21-item questionnaire with Likert scale of 0-5, with 0 for "I did not experience this change as a result of my crisis" and 5 for "I experienced this change to a very great degree as a result of my crisis")
  measure: Depression
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Patient Health Questionnaire (PHQ-2) (2-items measuring depression using Likert scale of 0 to 3 with 0 for "not at all" and 3 for "nearly every day)
  measure: Anxiety
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Generalized Anxiety Disorder Scale (GAD-2) (2-items measuring anxiety with 4-point Likert scale with 0 for "not at all" and 3 for "nearly every day")
  measure: Professional Quality of Life for Health care workers
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Professional Quality of Life Health (Pro-QOL Health) (30-items covering five domains (6 items each domain): 1) Compassion Satisfaction, 2) Perceived Support, 3) Burnout, 4) Secondary Traumatic Stress, and 5) Moral Distress using a Likert scale of 1-5 with 1 for "never" and 5 for "very often")
  measure: Cardiorespiratory fitness
  time frame: Group comparisons baseline, 3 months follow-up
  description: Cardiopulmonary exercise test (CPX-T). (Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle test)
  measure: 24-H Physical activity patterns
  time frame: Group comparisons baseline, 3 months follow-up
  description: GT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer to estimate the energy cost of free-living activity
  measure: Spiritual well-being
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: FACIT Spiritual Well-Being (FACIT-Sp) Non-Illness Version (12-items with a 5-point Likert with total score range from 0-32 with higher scores indicating better QOL/spiritual well-being)
  measure: Job Satisfaction
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Nurse Job Satisfaction Scale (7 items using a 5-point Likert scale from 1 for "strongly disagree" to 5 for "strongly agree")
  measure: Missed Care
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: NDNQI Index of Work Satisfaction missed care (Two multiple choice questions about the last shift worked)
  measure: Work-related exhaustion
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Quality Work Competence (3-item subscale with 5-point Likert scale from 1 for "never" to 5 for "very often")
  measure: Medical Errors
  time frame: Group comparisons baseline, 3 months, and 6 months follow-up
  description: Single-item medical error question.
  measure: Sleep
  time frame: Group comparisons baseline, week 12
  description: GT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer sleep measurements to determine total sleep time, sleep efficiency, and sleep latency.
  measure: Sleep questionnaire
  time frame: Group comparisons baseline, week 12
  description: Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)
  measure: Sleep diary
  time frame: Group comparisons baseline, week 12
  description: National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)
  measure: Cognitive Health
  time frame: Group comparison baseline, 1 week follow-up
  description: Workplace Cognitive Failure Scale (15 items about experiences during last work week with Likert scale from 1 for "never" to 5 for "very often")
  measure: Insulin resistance
  time frame: Group comparison baseline, 1 week follow-up
  description: Blood collection fasting glucose, fasting insulin, lipid panel profile
  measure: Weight
  time frame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
  description: Weight in kilograms
  measure: Waist circumference
  time frame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
  description: Waist circumference in centimeters
  measure: Body Mass Index
  time frame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
  description: Calculated body mass index based on current weight in kilograms and height in centimeters taken at baseline
  measure: Body composition
  time frame: Group comparison baseline, 1 week follow-up
  description: DEXA scan
  measure: Nutrition
  time frame: Group comparison baseline, 1 week follow-up
  description: Diet history Questionnaire-III (DHQ-III) (A questionnaire on beverage and food intake over the past month with branching items on amount of consumption based on responses)
  measure: Physical condition - strength
  time frame: Group comparison baseline, 1 week follow-up
  description: Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer
  measure: Physical Activity
  time frame: Group comparison baseline, 1 week follow-up
  description: International Physical Activity Questionnaire (IPAQ) (27 maximum branching items with 5 parts: 1) Job-related physical activity, 2) Transportation physical activity, 3) Housework, house maintenance, and caring for family, 4) Recreation, sport, and leisure-time physical activity, 5) Time spent sitting
  measure: Lifestyle Beliefs
  time frame: Group comparison baseline, 1 week follow-up
  description: Healthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"
  measure: Lifestyle Behaviors
  time frame: Group comparison baseline, 1 week follow-up
  description: Healthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"
  measure: Adherence/Compliance
  time frame: 1 week follow-up
  description: Percentage of exercise session attendance (number of attended sessions/the number of scheduled sessions)
  arm group label: Exercise Training Group
  arm group type: Experimental
  description: Exercise intervention group will undergo a 12-week exercise program.
  arm group label: Wait-List Control Group
  arm group type: Other
  description: Wait-List control group will participate in visits every 4 weeks for data collection and periodic phone calls for monitoring. They will be offered the exercise training intervention option at conclusion.
  intervention type: Behavioral
  intervention name: Exercise training group
  description: 12-Week Exercise intervention on mentaL, metabolic, physicaL, spiritual, social, and occupational well-being among shift-working acute care NURSE
  arm group label: Exercise Training Group
  intervention type: Behavioral
  intervention name: Wait-List Control Group
  description: Control group
  arm group label: Wait-List Control Group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeanette Green, PhD
  role: Principal Investigator
  affiliation: AdventHealth
  last name: Jeanette Green, PhD
  phone: 407-200-2901
  email: jeanette.green@adventhealth.com
  last name: Andrea Brennan, PhD
  phone: 407-200-2901
  email: andrea.brennan@adventhealth.com
  citation: Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.
  PMID: 25030030
  citation: Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.
  PMID: 25576495
  citation: Vetter C, Devore EE, Wegrzyn LR, Massa J, Speizer FE, Kawachi I, Rosner B, Stampfer MJ, Schernhammer ES. Association Between Rotating Night Shift Work and Risk of Coronary Heart Disease Among Women. JAMA. 2016 Apr 26;315(16):1726-34. doi: 10.1001/jama.2016.4454.
  PMID: 27115377
  citation: Brown JP, Martin D, Nagaria Z, Verceles AC, Jobe SL, Wickwire EM. Mental Health Consequences of Shift Work: An Updated Review. Curr Psychiatry Rep. 2020 Jan 18;22(2):7. doi: 10.1007/s11920-020-1131-z.
  PMID: 31955278
  citation: Torquati L, Mielke GI, Brown WJ, Burton NW, Kolbe-Alexander TL. Shift Work and Poor Mental Health: A Meta-Analysis of Longitudinal Studies. Am J Public Health. 2019 Nov;109(11):e13-e20. doi: 10.2105/AJPH.2019.305278. Epub 2019 Sep 19.
  PMID: 31536404
  citation: American Nurses Association. Healthy Nurse Healthy Nation: Year Three Highlights 2019-2020, <https://www.healthynursehealthynation.org/globalassets/all-images-view-with-media/about/2020-hnhn_sup-8.pdf> (2020)
  citation: Chellappa SL, Morris CJ, Scheer FAJL. Circadian misalignment increases mood vulnerability in simulated shift work. Sci Rep. 2020 Oct 29;10(1):18614. doi: 10.1038/s41598-020-75245-9.
  PMID: 33122670
  citation: Scheer FAJL, Chellappa SL, Hu K, Shea SA. Impact of mental stress, the circadian system and their interaction on human cardiovascular function. Psychoneuroendocrinology. 2019 May;103:125-129. doi: 10.1016/j.psyneuen.2019.01.016. Epub 2019 Jan 16.
  PMID: 30682628
  citation: Sletten TL, Cappuccio FP, Davidson AJ, Van Cauter E, Rajaratnam SMW, Scheer FAJL. Health consequences of circadian disruption. Sleep. 2020 Jan 13;43(1):zsz194. doi: 10.1093/sleep/zsz194. No abstract available.
  PMID: 31930347
  citation: Vetter C, Scheer FAJL. A healthy lifestyle - reducing T2DM risk in shift workers? Nat Rev Endocrinol. 2019 Apr;15(4):194-196. doi: 10.1038/s41574-019-0164-z. No abstract available.
  PMID: 30718862
  citation: McHill AW, Melanson EL, Higgins J, Connick E, Moehlman TM, Stothard ER, Wright KP Jr. Impact of circadian misalignment on energy metabolism during simulated nightshift work. Proc Natl Acad Sci U S A. 2014 Dec 2;111(48):17302-7. doi: 10.1073/pnas.1412021111. Epub 2014 Nov 17.
  PMID: 25404342
  citation: Stuijfzand S, Deforges C, Sandoz V, Sajin CT, Jaques C, Elmers J, Horsch A. Psychological impact of an epidemic/pandemic on the mental health of healthcare professionals: a rapid review. BMC Public Health. 2020 Aug 12;20(1):1230. doi: 10.1186/s12889-020-09322-z.
  PMID: 32787815
  citation: Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016 Jul 8;11(7):e0159015. doi: 10.1371/journal.pone.0159015. eCollection 2016.
  PMID: 27391946
  citation: Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
  PMID: 26606383
  citation: Melnyk BM, Kelly SA, Stephens J, Dhakal K, McGovern C, Tucker S, Hoying J, McRae K, Ault S, Spurlock E, Bird SB. Interventions to Improve Mental Health, Well-Being, Physical Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review. Am J Health Promot. 2020 Nov;34(8):929-941. doi: 10.1177/0890117120920451. Epub 2020 Apr 27.
  PMID: 32338522
  citation: Bischoff LL, Otto AK, Hold C, Wollesen B. The effect of physical activity interventions on occupational stress for health personnel: A systematic review. Int J Nurs Stud. 2019 Sep;97:94-104. doi: 10.1016/j.ijnurstu.2019.06.002. Epub 2019 Jun 11.
  PMID: 31234106
  citation: Chappel SE, Verswijveren SJJM, Aisbett B, Considine J, Ridgers ND. Nurses' occupational physical activity levels: A systematic review. Int J Nurs Stud. 2017 Aug;73:52-62. doi: 10.1016/j.ijnurstu.2017.05.006. Epub 2017 May 10.
  PMID: 28535398
  citation: Chen, J. et al. Physical activity and post-traumatic growth: A systematic review of quantitative and qualitative studies. Psychology of Sport & Exercise 49, doi:10.1016/j.psychsport.2020.101679 (2020).
  citation: Constandt B, Thibaut E, De Bosscher V, Scheerder J, Ricour M, Willem A. Exercising in Times of Lockdown: An Analysis of the Impact of COVID-19 on Levels and Patterns of Exercise among Adults in Belgium. Int J Environ Res Public Health. 2020 Jun 10;17(11):4144. doi: 10.3390/ijerph17114144.
  PMID: 32532013
  citation: Coulson, J. C., McKenna, J. & Field, M. Exercising at work and self-reported work performance. International Journal of Workplace Health Management 1, 176-197, doi:10/1108/17538350810926534 (2008).
  citation: Doran K, Resnick B, Alghzawi H, Zhu S. The worksite heart health improvement project's impact on behavioral risk factors for cardiovascular disease in long-term care: A randomized control trial. Int J Nurs Stud. 2018 Oct;86:107-114. doi: 10.1016/j.ijnurstu.2018.06.011. Epub 2018 Jun 28.
  PMID: 30005312
  citation: Jakobsen MD, Sundstrup E, Brandt M, Andersen LL. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial. BMC Public Health. 2017 Oct 10;17(1):798. doi: 10.1186/s12889-017-4728-3.
  PMID: 29017479
  citation: Matsugaki R, Kuhara S, Saeki S, Jiang Y, Michishita R, Ohta M, Yamato H. Effectiveness of workplace exercise supervised by a physical therapist among nurses conducting shift work: A randomized controlled trial. J Occup Health. 2017 Jul 27;59(4):327-335. doi: 10.1539/joh.16-0125-OA. Epub 2017 Jun 20.
  PMID: 28638000
  citation: Ochentel O, Humphrey C, Pfeifer K. Efficacy of Exercise Therapy in Persons with Burnout. A Systematic Review and Meta-Analysis. J Sports Sci Med. 2018 Aug 14;17(3):475-484. eCollection 2018 Sep.
  PMID: 30116121
  citation: Tucker S, Farrington M, Lanningham-Foster LM, Clark MK, Dawson C, Quinn GJ, Laffoon T, Perkhounkova Y. Worksite Physical Activity Intervention for Ambulatory Clinic Nursing Staff. Workplace Health Saf. 2016 Jul;64(7):313-25. doi: 10.1177/2165079916633225. Epub 2016 May 3.
  PMID: 27143144
  citation: White MI, Dionne CE, Warje O, Koehoorn M, Wagner SL, Schultz IZ, Koehn C, Williams-Whitt K, Harder HG, Pasca R, Hsu V, McGuire L, Schulz W, Kube D, Wright MD. Physical Activity and Exercise Interventions in the Workplace Impacting Work Outcomes: A Stakeholder-Centered Best Evidence Synthesis of Systematic Reviews. Int J Occup Environ Med. 2016 Apr;7(2):61-74. doi: 10.15171/ijoem.2016.739.
  PMID: 27112715
  citation: Bridgland VME, Moeck EK, Green DM, Swain TL, Nayda DM, Matson LA, Hutchison NP, Takarangi MKT. Why the COVID-19 pandemic is a traumatic stressor. PLoS One. 2021 Jan 11;16(1):e0240146. doi: 10.1371/journal.pone.0240146. eCollection 2021.
  PMID: 33428630
  citation: Marcomini I, Agus C, Milani L, Sfogliarini R, Bona A, Castagna M. COVID-19 and post-traumatic stress disorder among nurses: a descriptive cross-sectional study in a COVID hospital. Med Lav. 2021 Jun 15;112(3):241-249. doi: 10.23749/mdl.v112i3.11129.
  PMID: 34142675
  citation: Tedeschi, R. G. & Calhoun, L. G. Posttraumatic growth: Conceptual foundations and empirical evidence. Psychological Inquiry 15, 1-18 (2004).
  citation: National Center for Complementary and Integrative Health. (National Center for Complementary and Integrative Health, 2021).
  citation: U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd edition edn, (Department of Health and Human Services, 2018).
  citation: Linke SE, Gallo LC, Norman GJ. Attrition and adherence rates of sustained vs. intermittent exercise interventions. Ann Behav Med. 2011 Oct;42(2):197-209. doi: 10.1007/s12160-011-9279-8.
  PMID: 21604068
  responsible party type: Sponsor
  sharing ipd: No