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Psychological WellnessWELL_NURSENCT05966805

Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses

A study testing Exercise training group in people with Psychological Wellness, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Psychological Wellness
What is being tested?
Exercise training group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
13 Sep 2023to 13 May 2025
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Medically diagnosed sleep disorder
  • Weight >450 lbs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth

    Orlando, Florida, 32803

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Exercise training group, Wait-List Control Group
Keywords
exercise, whole person health, nurses, pilot study
Medical subject headings
Psychological Well-Being, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training groupBehavioural

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

  • Wait-List Control GroupBehavioural

    Control group

Study groups in NCT05966805
Study groupRoleWhat they receive
Exercise Training GroupExperimentalExercise intervention group will undergo a 12-week exercise program.
Receives: Behavioral: Exercise training group
Wait-List Control GroupOtherWait-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.
Receives: Behavioral: Wait-List Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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")

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

Secondary outcomes (24)

  1. Depression

    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)

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

  2. Anxiety

    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")

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

  3. Professional Quality of Life for Health care workers

    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")

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

  4. Cardiorespiratory fitness

    Cardiopulmonary exercise test (CPX-T). (Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle test)

    Measured: Group comparisons baseline, 3 months follow-up

  5. 24-H Physical activity patterns

    GT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer to estimate the energy cost of free-living activity

    Measured: Group comparisons baseline, 3 months follow-up

  6. Spiritual well-being

    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)

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

  7. Job Satisfaction

    Nurse Job Satisfaction Scale (7 items using a 5-point Likert scale from 1 for "strongly disagree" to 5 for "strongly agree")

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

  8. Missed Care

    NDNQI Index of Work Satisfaction missed care (Two multiple choice questions about the last shift worked)

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

  9. Work-related exhaustion

    Quality Work Competence (3-item subscale with 5-point Likert scale from 1 for "never" to 5 for "very often")

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

  10. Medical Errors

    Single-item medical error question.

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

  11. Sleep

    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.

    Measured: Group comparisons baseline, week 12

  12. Sleep questionnaire

    Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)

    Measured: Group comparisons baseline, week 12

  13. Sleep diary

    National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)

    Measured: Group comparisons baseline, week 12

  14. Cognitive Health

    Workplace Cognitive Failure Scale (15 items about experiences during last work week with Likert scale from 1 for "never" to 5 for "very often")

    Measured: Group comparison baseline, 1 week follow-up

  15. Insulin resistance

    Blood collection fasting glucose, fasting insulin, lipid panel profile

    Measured: Group comparison baseline, 1 week follow-up

  16. Weight

    Weight in kilograms

    Measured: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up

  17. Waist circumference

    Waist circumference in centimeters

    Measured: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up

  18. Body Mass Index

    Calculated body mass index based on current weight in kilograms and height in centimeters taken at baseline

    Measured: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up

  19. Body composition

    DEXA scan

    Measured: Group comparison baseline, 1 week follow-up

  20. Nutrition

    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)

    Measured: Group comparison baseline, 1 week follow-up

  21. Physical condition - strength

    Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer

    Measured: Group comparison baseline, 1 week follow-up

  22. Physical Activity

    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

    Measured: Group comparison baseline, 1 week follow-up

  23. Lifestyle Beliefs

    Healthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"

    Measured: Group comparison baseline, 1 week follow-up

  24. Lifestyle Behaviors

    Healthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"

    Measured: Group comparison baseline, 1 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start13 Sep 2023
  3. Primary completion13 May 2025
  4. Study completion13 May 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05966805
Sponsor's protocol ID
1762353
Acronym
WELL_NURSE
Status last verified
Sep 2025
First submitted
6 Jun 2023
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25030030

  • 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.

    PubMed 25576495

  • 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.

    PubMed 27115377

  • 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.

    PubMed 31955278

  • 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.

    PubMed 31536404

  • 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)

  • 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.

    PubMed 33122670

  • 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.

    PubMed 30682628

  • 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.

    PubMed 31930347

  • 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.

    PubMed 30718862

  • 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.

    PubMed 25404342

  • 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.

    PubMed 32787815

  • 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.

    PubMed 27391946

  • 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.

    PubMed 26606383

  • 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.

    PubMed 32338522

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training group in people with Psychological Wellness, run by AdventHealth at 1 site in United States.

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 7 inclusion and 17 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 13 Nov 2025. 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 United States. 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?

Post-traumatic growth (time frame: Group comparison baseline, 3 months, and 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05966805, which also lists 32 linked publications.

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 13 Nov 2025.

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