NCT05966805

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
Last Updated

November 13, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

June 6, 2023

Last Update Submit

November 11, 2025

Conditions

Keywords

exercisewhole person healthnursespilot study

Outcome Measures

Primary Outcomes (1)

  • Post-traumatic growth

    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")

    Group comparison baseline, 3 months, and 6 months follow-up

Secondary Outcomes (24)

  • Depression

    Group comparisons baseline, 3 months, and 6 months follow-up

  • Anxiety

    Group comparisons baseline, 3 months, and 6 months follow-up

  • Professional Quality of Life for Health care workers

    Group comparisons baseline, 3 months, and 6 months follow-up

  • Cardiorespiratory fitness

    Group comparisons baseline, 3 months follow-up

  • 24-H Physical activity patterns

    Group comparisons baseline, 3 months follow-up

  • +19 more secondary outcomes

Other Outcomes (1)

  • Adherence/Compliance

    1 week follow-up

Study Arms (2)

Exercise Training Group

EXPERIMENTAL

Exercise intervention group will undergo a 12-week exercise program.

Behavioral: Exercise training group

Wait-List Control Group

OTHER

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.

Behavioral: Wait-List Control Group

Interventions

12-Week Exercise intervention on mentaL, metabolic, physicaL, spiritual, social, and occupational well-being among shift-working acute care NURSE

Exercise Training Group

Control group

Wait-List Control Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-65 years
  • Nurse working in an AdventHealth inpatient acute care setting
  • Currently working as a shift-working acute care nurse within AdventHealth.
  • Weight stable prior to beginning the study exercise training intervention.
  • Able to speak and understand written and spoken English.
  • Understands the procedures and agrees to participate by giving written informed consent.
  • Willing and able to comply with scheduled visits, laboratory tests, and other study procedures including a 12-week exercise training program.

You may not qualify if:

  • Positive urine pregnancy test prior to DEXA scan
  • Uncontrolled Type 1 or Type 2 diabetes mellitus
  • Bleeding disorders
  • Acute or chronic infections
  • Chronic obstructive pulmonary disease
  • Renal insufficiency or nephritis
  • Uncontrolled hypertension (BP\>160 mmHg systolic or \>100 mmHg diastolic)
  • History of Cushing's disease or syndrome
  • Active rheumatoid arthritis or other inflammatory rheumatic disorder
  • Major surgery within 4 weeks prior to Screening
  • Participation in studies involving investigational drug(s) within 30 days prior to Screening
  • History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
  • Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
  • Presence of any condition that, in the opinion of the Investigator or medical investigator, compromises participant safety or data integrity or the participant's ability to complete study days.
  • More than 1-day a week of intentional exercise
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth

Orlando, Florida, 32803, United States

Location

Related Publications (32)

  • 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: 25030030BACKGROUND
  • 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: 25576495BACKGROUND
  • 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: 27115377BACKGROUND
  • 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: 31955278BACKGROUND
  • 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: 31536404BACKGROUND
  • 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)

    BACKGROUND
  • 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: 33122670BACKGROUND
  • 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: 30682628BACKGROUND
  • 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: 31930347BACKGROUND
  • 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: 30718862BACKGROUND
  • 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: 25404342BACKGROUND
  • 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: 32787815BACKGROUND
  • 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: 27391946BACKGROUND
  • 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: 26606383BACKGROUND
  • 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: 32338522BACKGROUND
  • 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: 31234106BACKGROUND
  • 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: 28535398BACKGROUND
  • 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).

    BACKGROUND
  • 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: 32532013BACKGROUND
  • 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).

    BACKGROUND
  • 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: 30005312BACKGROUND
  • 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: 29017479BACKGROUND
  • 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: 28638000BACKGROUND
  • 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: 30116121BACKGROUND
  • 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: 27143144BACKGROUND
  • 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: 27112715BACKGROUND
  • 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: 33428630BACKGROUND
  • 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: 34142675BACKGROUND
  • Tedeschi, R. G. & Calhoun, L. G. Posttraumatic growth: Conceptual foundations and empirical evidence. Psychological Inquiry 15, 1-18 (2004).

    BACKGROUND
  • National Center for Complementary and Integrative Health. (National Center for Complementary and Integrative Health, 2021).

    BACKGROUND
  • U.S. Department of Health and Human Services. Physical Activity Guidelines for Americans. 2nd edition edn, (Department of Health and Human Services, 2018).

    BACKGROUND
  • 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: 21604068BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Andrea Brennan, PhD

    AdventHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

August 1, 2023

Study Start

September 13, 2023

Primary Completion

May 13, 2025

Study Completion

May 13, 2025

Last Updated

November 13, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations