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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05966805
Acronym
WELL_NURSE
Enrollment
21
Registered
2023-08-01
Start date
2023-09-13
Completion date
2025-05-13
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Wellness

Keywords

exercise, whole person health, nurses, pilot study

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.

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.

Interventions

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

Control group

Sponsors

AdventHealth
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 1. Age 21-65 years 2. Nurse working in an AdventHealth inpatient acute care setting 3. Currently working as a shift-working acute care nurse within AdventHealth. 4. Weight stable prior to beginning the study exercise training intervention. 5. Able to speak and understand written and spoken English. 6. Understands the procedures and agrees to participate by giving written informed consent. 7. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures including a 12-week exercise training program.

Exclusion criteria

1. Positive urine pregnancy test prior to DEXA scan 2. Uncontrolled Type 1 or Type 2 diabetes mellitus 3. Bleeding disorders 4. Acute or chronic infections 5. Chronic obstructive pulmonary disease 6. Renal insufficiency or nephritis 7. Uncontrolled hypertension (BP\>160 mmHg systolic or \>100 mmHg diastolic) 8. History of Cushing's disease or syndrome 9. Active rheumatoid arthritis or other inflammatory rheumatic disorder 10. Major surgery within 4 weeks prior to Screening 11. Participation in studies involving investigational drug(s) within 30 days prior to Screening 12. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator) 13. 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) 14. 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. 15. More than 1-day a week of intentional exercise 16. Medically diagnosed sleep disorder 17. Weight \>450 lbs

Design outcomes

Primary

MeasureTime frameDescription
Post-traumatic growthGroup comparison baseline, 3 months, and 6 months follow-upPost-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

MeasureTime frameDescription
Medical ErrorsGroup comparisons baseline, 3 months, and 6 months follow-upSingle-item medical error question.
DepressionGroup comparisons baseline, 3 months, and 6 months follow-upPatient 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)
AnxietyGroup comparisons baseline, 3 months, and 6 months follow-upGeneralized 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)
Professional Quality of Life for Health care workersGroup comparisons baseline, 3 months, and 6 months follow-upProfessional 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)
Cardiorespiratory fitnessGroup comparisons baseline, 3 months follow-upCardiopulmonary exercise test (CPX-T). (Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle test)
24-H Physical activity patternsGroup comparisons baseline, 3 months follow-upGT3-X-BT, ActiGraph, LLC) monitor integrates motion sensor data from the tri-axial accelerometer to estimate the energy cost of free-living activity
Spiritual well-beingGroup comparisons baseline, 3 months, and 6 months follow-upFACIT 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)
Job SatisfactionGroup comparisons baseline, 3 months, and 6 months follow-upNurse Job Satisfaction Scale (7 items using a 5-point Likert scale from 1 for strongly disagree to 5 for strongly agree)
Missed CareGroup comparisons baseline, 3 months, and 6 months follow-upNDNQI Index of Work Satisfaction missed care (Two multiple choice questions about the last shift worked)
Work-related exhaustionGroup comparisons baseline, 3 months, and 6 months follow-upQuality Work Competence (3-item subscale with 5-point Likert scale from 1 for never to 5 for very often)
SleepGroup comparisons baseline, week 12GT3-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.
Sleep questionnaireGroup comparisons baseline, week 12Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)
Cognitive HealthGroup comparison baseline, 1 week follow-upWorkplace Cognitive Failure Scale (15 items about experiences during last work week with Likert scale from 1 for never to 5 for very often)
Insulin resistanceGroup comparison baseline, 1 week follow-upBlood collection fasting glucose, fasting insulin, lipid panel profile
WeightGroup comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-upWeight in kilograms
Waist circumferenceGroup comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-upWaist circumference in centimeters
Body Mass IndexGroup comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-upCalculated body mass index based on current weight in kilograms and height in centimeters taken at baseline
Body compositionGroup comparison baseline, 1 week follow-upDEXA scan
NutritionGroup comparison baseline, 1 week follow-upDiet 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)
Physical condition - strengthGroup comparison baseline, 1 week follow-upMuscle power testing will be performed using a Biodex pneumatic-driven dynamometer
Physical ActivityGroup comparison baseline, 1 week follow-upInternational 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
Lifestyle BeliefsGroup comparison baseline, 1 week follow-upHealthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from Strongly Disagree to Strongly Agree
Lifestyle BehaviorsGroup comparison baseline, 1 week follow-upHealthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from Strongly Disagree to Strongly Agree
Sleep diaryGroup comparisons baseline, week 12National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)

Other

MeasureTime frameDescription
Adherence/Compliance1 week follow-upPercentage of exercise session attendance (number of attended sessions/the number of scheduled sessions)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026