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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Psychological Wellness

Intervention / Treatment
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* Behavioral: Exercise training group
* Behavioral: Wait-List Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Training Group<br>Exercise intervention group will undergo a 12-week exercise program. | Behavioral: Exercise training group<br>* 12-Week Exercise intervention on mentaL, metabolic, physicaL, spiritual, social, and occupational well-being among shift-working acute care NURSE<br>|
| Other: Wait-List Control Group<br>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<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| 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) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| 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) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| Cardiorespiratory fitness | Cardiopulmonary exercise test (CPX-T). (Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle test) | Group comparisons baseline, 3 months follow-up | 
| 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 | Group comparisons baseline, 3 months follow-up | 
| 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) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| Job Satisfaction | Nurse Job Satisfaction Scale (7 items using a 5-point Likert scale from 1 for strongly disagree to 5 for strongly agree) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| Missed Care | NDNQI Index of Work Satisfaction missed care (Two multiple choice questions about the last shift worked) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| Work-related exhaustion | Quality Work Competence (3-item subscale with 5-point Likert scale from 1 for never to 5 for very often) | Group comparisons baseline, 3 months, and 6 months follow-up | 
| Medical Errors | Single-item medical error question. | Group comparisons baseline, 3 months, and 6 months follow-up | 
| 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. | Group comparisons baseline, week 12 | 
| Sleep questionnaire | Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items) | Group comparisons baseline, week 12 | 
| Sleep diary | National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm) | Group comparisons baseline, week 12 | 
| 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) | Group comparison baseline, 1 week follow-up | 
| Insulin resistance | Blood collection fasting glucose, fasting insulin, lipid panel profile | Group comparison baseline, 1 week follow-up | 
| Weight | Weight in kilograms | Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up | 
| Waist circumference | Waist circumference in centimeters | Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up | 
| Body Mass Index | Calculated body mass index based on current weight in kilograms and height in centimeters taken at baseline | Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up | 
| Body composition | DEXA scan | Group comparison baseline, 1 week follow-up | 
| 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) | Group comparison baseline, 1 week follow-up | 
| Physical condition - strength | Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer | Group comparison baseline, 1 week follow-up | 
| 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 | Group comparison baseline, 1 week follow-up | 
| Lifestyle Beliefs | Healthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from Strongly Disagree to Strongly Agree | Group comparison baseline, 1 week follow-up | 
| Lifestyle Behaviors | Healthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from Strongly Disagree to Strongly Agree | Group comparison baseline, 1 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, whole person health, nurses, pilot study