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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Post-traumatic growth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Post-traumatic growth
时间窗: 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")
次要结局
- Depression(Group comparisons baseline, 3 months, and 6 months follow-up)
- Body composition(Group comparison baseline, 1 week follow-up)
- Anxiety(Group comparisons baseline, 3 months, and 6 months follow-up)
- Cardiorespiratory fitness(Group comparisons baseline, 3 months follow-up)
- Job Satisfaction(Group comparisons baseline, 3 months, and 6 months follow-up)
- Missed Care(Group comparisons baseline, 3 months, and 6 months follow-up)
- Work-related exhaustion(Group comparisons baseline, 3 months, and 6 months follow-up)
- Sleep questionnaire(Group comparisons baseline, week 12)
- Weight(Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up)
- Professional Quality of Life for Health care workers(Group comparisons baseline, 3 months, and 6 months follow-up)
- 24-H Physical activity patterns(Group comparisons baseline, 3 months follow-up)
- Spiritual well-being(Group comparisons baseline, 3 months, and 6 months follow-up)
- Medical Errors(Group comparisons baseline, 3 months, and 6 months follow-up)
- Physical Activity(Group comparison baseline, 1 week follow-up)
- Lifestyle Behaviors(Group comparison baseline, 1 week follow-up)
- Sleep(Group comparisons baseline, week 12)
- Sleep diary(Group comparisons baseline, week 12)
- Cognitive Health(Group comparison baseline, 1 week follow-up)
- Insulin resistance(Group comparison baseline, 1 week follow-up)
- Waist circumference(Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up)
- Body Mass Index(Group comparison baseline, week 1, week 4, week 8, week 12, 1 week follow-up)
- Lifestyle Beliefs(Group comparison baseline, 1 week follow-up)
- Physical condition - strength(Group comparison baseline, 1 week follow-up)
- Nutrition(Group comparison baseline, 1 week follow-up)