Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses
- Conditions
- Psychological Wellness
- Interventions
- Behavioral: Wait-List Control GroupBehavioral: Exercise training group
- Registration Number
- NCT05966805
- Lead Sponsor
- AdventHealth
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wait-List Control Group Wait-List Control Group 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. Exercise Training Group Exercise training group Exercise intervention group will undergo a 12-week exercise program.
- Primary Outcome Measures
Name Time Method Post-traumatic growth 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 Outcome Measures
Name Time Method Body composition Group comparison baseline, 1 week follow-up DEXA scan
Depression 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)
Anxiety 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")
Cardiorespiratory fitness 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)
Job Satisfaction 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")
Missed Care 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)
Work-related exhaustion 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")
Sleep questionnaire Group comparisons baseline, week 12 Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)
Weight Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up Weight in kilograms
Professional Quality of Life for Health care workers 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")
24-H Physical activity patterns 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
Spiritual well-being 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)
Medical Errors Group comparisons baseline, 3 months, and 6 months follow-up Single-item medical error question.
Physical Activity 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
Lifestyle Behaviors Group comparison baseline, 1 week follow-up Healthy Lifestyle Behaviors Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"
Sleep 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.
Sleep diary Group comparisons baseline, week 12 National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)
Cognitive Health 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")
Insulin resistance Group comparison baseline, 1 week follow-up Blood collection fasting glucose, fasting insulin, lipid panel profile
Waist circumference Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up Waist circumference in centimeters
Body Mass Index 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
Lifestyle Beliefs Group comparison baseline, 1 week follow-up Healthy Lifestyle Beliefs Scale (16 items with 5-point Likert scale from "Strongly Disagree" to "Strongly Agree"
Physical condition - strength Group comparison baseline, 1 week follow-up Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer
Nutrition 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)
Trial Locations
- Locations (1)
AdventHealth
🇺🇸Orlando, Florida, United States