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Completed

NCT Number: NCT05966805

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth

Orlando, Florida, 32803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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.

Exclusion criteria

  • 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
  • Medically diagnosed sleep disorder
  • Weight >450 lbs

Treatment and study plan

Exercise training group

Behavioral

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

Wait-List Control Group

Behavioral

Control group

Primary outcomes

  1. Post-traumatic growth

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

    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")

Secondary outcomes

  1. Depression

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

    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)

  2. Anxiety

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

    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")

  3. Professional Quality of Life for Health care workers

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

    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")

  4. Cardiorespiratory fitness

    Time frame: Group comparisons baseline, 3 months follow-up

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

  5. 24-H Physical activity patterns

    Time frame: Group comparisons baseline, 3 months follow-up

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

  6. Spiritual well-being

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

    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)

  7. Job Satisfaction

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

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

  8. Missed Care

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

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

  9. Work-related exhaustion

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

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

  10. Medical Errors

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

    Single-item medical error question.

  11. Sleep

    Time frame: Group comparisons baseline, week 12

    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.

  12. Sleep questionnaire

    Time frame: Group comparisons baseline, week 12

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

  13. Sleep diary

    Time frame: Group comparisons baseline, week 12

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

  14. Cognitive Health

    Time frame: Group comparison baseline, 1 week follow-up

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

  15. Insulin resistance

    Time frame: Group comparison baseline, 1 week follow-up

    Blood collection fasting glucose, fasting insulin, lipid panel profile

  16. Weight

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

    Weight in kilograms

  17. Waist circumference

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

    Waist circumference in centimeters

  18. Body Mass Index

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

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

  19. Body composition

    Time frame: Group comparison baseline, 1 week follow-up

    DEXA scan

  20. Nutrition

    Time frame: Group comparison baseline, 1 week follow-up

    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)

  21. Physical condition - strength

    Time frame: Group comparison baseline, 1 week follow-up

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

  22. Physical Activity

    Time frame: Group comparison baseline, 1 week follow-up

    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

  23. Lifestyle Beliefs

    Time frame: Group comparison baseline, 1 week follow-up

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

  24. Lifestyle Behaviors

    Time frame: Group comparison baseline, 1 week follow-up

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

Other outcomes

  1. Adherence/Compliance

    Time frame: 1 week follow-up

    Percentage of exercise session attendance (number of attended sessions/the number of scheduled sessions)

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study 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

Acronym: WELL_NURSE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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