Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to learn more about how patients recover after DIEP flap breast reconstruction. We will use a wrist worn activity tracker (Fitbit Inspire 3) to measure steps, heart rate, and sleep before and after surgery, and we will compare this information with short questionnaires about your recovery. The information we learn may help improve patient counseling and design future recovery programs.
详细描述
Primary Objectives:
The primary objective of [SH1.1][PH1.2]this study is to determine the time until return to baseline physical activity following DIEP flap breast reconstruction, as measured by the participant's average daily preoperative step count using the Fitbit Inspire 3 wearable device. Return to baseline is defined as a 7-day rolling average of daily steps reaching at least 95 percent of the patient's preoperative baseline step average. This objective seeks to establish an objective, quantifiable recovery metric that can serve as a benchmark for postoperative functional recovery in autologous breast reconstruction.
Secondary Objectives:
- Assessing the feasibility and adherence of continuous wearable data collection before and after DIEP flap surgery, including wear time and data completeness.
- Evaluating perioperative trends in heart rate and sleep parameters, and their relationship to overall recovery patterns.
- Exploring associations between wearable-derived recovery metrics (e.g., activity and sleep) and short-term clinical outcomes such as wound complications, seroma, hematoma, DVT/VTE, readmission, and length of stay.
- Comparing wearable activity tracker data with patient-reported activity levels to evaluate agreement between objective and subjective recovery measures.
- Characterizing baseline lifestyle factors - specifically music listening time, active music engagement, and live concert attendance (Gold-MSI Active Engagement subscale) - and exploring their associations with time to return-to-baseline activity, perioperative sleep parameters, and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled for delayed[SH6.1][PH6.2] unilateral or bilateral DIEP flap breast reconstruction.
- •Able and willing to provide informed consent.
- •Possession of a compatible smartphone or tablet capable of syncing with the Fitbit Inspire 3 app.
- •Willingness to wear the activity tracker continuously for three weeks preoperatively and three months postoperatively.
排除标准
- •Inability or unwillingness to wear a wrist-worn or ankle-worn activity tracker.
- •Significant dermatologic conditions, wound, or allergy preventing safe use of a wrist-worn or ankle-worn device.
- •Planned additional concurrent surgical procedure (non-reconstructive) expected to significantly alter activity level or recovery trajectory (i.e. BSO, CPM).
- •Participation in another interventional clinical trial that may confound activity or recovery data.
- •Inability to provide informed consent or complete required questionnaires.
研究组 & 干预措施
All Patients
Eligible participants will be identified through scheduled preoperative consultations in the plastic surgery clinic.
干预措施: Questionnaires (Behavioral)
