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

AdventHealth

Status: Completed

Conditions: Psychological Wellness

Treatments: Behavioral: Wait-List Control Group; Behavioral: Exercise training group

Study type: Interventional

Funder types: Other

Identifiers

NCT05966805

1762353

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Exercise Training Group

Experimental group

Description:

Exercise intervention group will undergo a 12-week exercise program.

Treatment:

Behavioral: Exercise training group

Wait-List Control Group

Other group

Description:

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.

Treatment:

Behavioral: Wait-List Control Group