Clinical trial NCT05966805: Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychological Wellness
Keywords: exercise
whole person health
nurses
pilot study
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Post-traumatic growth
timeFrame: Group comparison baseline, 3 months, and 6 months follow-up
Secondary outcomes:
measure: Depression
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Anxiety
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Professional Quality of Life for Health care workers
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Cardiorespiratory fitness
timeFrame: Group comparisons baseline, 3 months follow-up
measure: 24-H Physical activity patterns
timeFrame: Group comparisons baseline, 3 months follow-up
measure: Spiritual well-being
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Job Satisfaction
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Missed Care
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Work-related exhaustion
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Medical Errors
timeFrame: Group comparisons baseline, 3 months, and 6 months follow-up
measure: Sleep
timeFrame: Group comparisons baseline, week 12
measure: Sleep questionnaire
timeFrame: Group comparisons baseline, week 12
measure: Sleep diary
timeFrame: Group comparisons baseline, week 12
measure: Cognitive Health
timeFrame: Group comparison baseline, 1 week follow-up
measure: Insulin resistance
timeFrame: Group comparison baseline, 1 week follow-up
measure: Weight
timeFrame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
measure: Waist circumference
timeFrame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
measure: Body Mass Index
timeFrame: Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up
measure: Body composition
timeFrame: Group comparison baseline, 1 week follow-up
measure: Nutrition
timeFrame: Group comparison baseline, 1 week follow-up
measure: Physical condition - strength
timeFrame: Group comparison baseline, 1 week follow-up
measure: Physical Activity
timeFrame: Group comparison baseline, 1 week follow-up
measure: Lifestyle Beliefs
timeFrame: Group comparison baseline, 1 week follow-up
measure: Lifestyle Behaviors
timeFrame: Group comparison baseline, 1 week follow-up
Other outcomes:
measure: Adherence/Compliance
timeFrame: 1 week follow-up
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Andrea Brennan, PhD
role: PRINCIPAL_INVESTIGATOR
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