Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-09 @ 7:26 PM
Study NCT ID:
NCT05966805
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2023-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Exercise Intervention on Well-being in Shift-working Acute Care Nurses
Sponsor:
AdventHealth
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WELL_NURSE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: