Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
研究概览
简要总结
The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. The investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. The overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. The importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. This would translate to increased healthcare value and better long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>18 years) who are undergoing elective abdominally-based plastic surgery operations in 3+ weeks by one of the following plastic surgeons: Nazerali, Lee, Murphy, Nguyen, Lorenz.
排除标准
- •Patients who do not speak English
- •Patients who do not have access to a smartphone or internet/cell service.
- •Patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.
研究组 & 干预措施
Control
The control arm will receive no additional prehabilitation material prior to material. Rather, they will receive standard preoperative care in which they will be given standard advice on nutrition and fitness. REDcap surveys will be administered.
Prehab Intervention Arm
The intervention arm will receive access to the prehab program (abdominal workout videos) and surveys via RedCAP.The program will start no less than 14 days before the date of surgery.
干预措施: Prehabilitation Program (Behavioral)
结局指标
主要结局
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14
时间窗: Post-operative days 7-14
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 30
时间窗: Post-operative day 30
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 30
时间窗: Post-operative day 30
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Occurrence of surgical complications (Post-op days 7-14)
时间窗: Post-operative days 7-14
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 30)
时间窗: Post-operative day 30
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 90)
时间窗: Post-operative day 90
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 180)
时间窗: Post-operative day 180
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Occurrence of surgical complications (Post-op day 360)
时间窗: Post-operative day 360
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op days 7-14
时间窗: Post-operative days 7-14
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 90
时间窗: Post-operative day 90
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 90
时间窗: Post-operative day 90
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 180
时间窗: Post-operative day 180
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 180
时间窗: Post-operative day 180
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 360
时间窗: Post-operative day 360
Will use the RAND 36-Item Health Survey (RAND-36) to assess the patient's perceived health following their surgical procedure. The score for RAND-36 ranges from 0-100, having higher scores mean better outcomes.
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 360
时间窗: Post-operative day 360
Will use the Abdominal Surgery Impact Scale (ASIS) to assess the patient's perceived health following their surgical procedure. The ASIS score ranges from 18-126, having higher scores indicate better quality of life.
Physical Function Test: 6-minute walk test at Time of Enrollment
时间窗: Time of enrollment
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand test at Time of Enrollment
时间窗: Time of enrollment
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test at Time of Enrollment
时间窗: Time of enrollment
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test at 3 weeks
时间窗: 3 weeks
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand test at 3 weeks
时间窗: 3 weeks
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test at 3 weeks
时间窗: 3 weeks
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test on Post-op Day 30
时间窗: Post-operative day 30
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand-test on Post-op Day 30
时间窗: Post-operative day 30
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test on Post-op Day 30
时间窗: Post-operative day 30
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
Physical Function Test: 6-minute walk test on Post-op Day 90
时间窗: Post-operative day 90
Will use the 6-minute walk test. The 6-minute walk test will be used to assess aerobic capacity and endurance. A normal walk distance ranges from 400 to 700 m.
Physical Function Test: 5-times-sit-to-stand test on Post-op Day 90
时间窗: Post-operative day 90
Will use the 5-times-sit-to-stand test. The 5-times-sit-to-stand test is a method to quantify functional lower extremity strength. Lower times indicate better scores.
Physical Function Test: Timed-up-and-go test on Post-op Day 90
时间窗: Post-operative day 90
Will use the timed-up-and-go test. The timed-up-and go test assesses one's mobility. A lower score signifies better mobility.
次要结局
- Change from Baseline Plasma Glucose Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline White Blood Cell Count at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hemoglobin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hematocrit Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Platelet Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Chloride Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Sodium Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Potassium Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Carbon Dioxide Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Creatinine Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Blood Glucose Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Albumin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Prealbumin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Transferrin Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline C-reactive Protein Levels at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery(Enrollment to time of surgery)
- Change from Baseline Hemoglobin A1C Levels at Time of Surgery(Enrollment to time of surgery)
研究者
Cara Black
Resident Physician, PGY-1
Stanford University