AdventHealth
Orlando, Florida, 32803, United States
NCT Number: NCT05966805
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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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Orlando, Florida, 32803, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion criteria
12-Week Exercise intervention on mentaL, metabolic, physicaL, spiritual, social, and occupational well-being among shift-working acute care NURSE
Control group
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")
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)
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")
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")
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)
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
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)
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")
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)
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")
Time frame: Group comparisons baseline, 3 months, and 6 months follow-up
Single-item medical error question.
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.
Time frame: Group comparisons baseline, week 12
Morningness-eveningness questionnaire Self-Report version (MEQ-REV-SR) (4 multiple choice items)
Time frame: Group comparisons baseline, week 12
National sleep foundation 7-day sleep diary (7 items for am and 8 items for pm)
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")
Time frame: Group comparison baseline, 1 week follow-up
Blood collection fasting glucose, fasting insulin, lipid panel profile
Time frame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
Weight in kilograms
Time frame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
Waist circumference in centimeters
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
Time frame: Group comparison baseline, 1 week follow-up
DEXA scan
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)
Time frame: Group comparison baseline, 1 week follow-up
Muscle power testing will be performed using a Biodex pneumatic-driven dynamometer
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
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"
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"
Time frame: 1 week follow-up
Percentage of exercise session attendance (number of attended sessions/the number of scheduled sessions)
AdventHealth
Other
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
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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