Are you healthy and looking to help advance medical science?
You may be eligible to participate in a ventral hernia clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a ventral hernia clinical study, and could be compensated for your time.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Are you healthy and looking to help advance medical science?
You may be eligible to participate in a ventral hernia clinical study, and could be compensated for your time.
Are you healthy and looking to help advance medical science? You may be eligible to participate in a ventral hernia clinical study, and could be compensated for your time.
Recruiting
Male & Female
19 Years +
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.
Details for the study
Brief Title
Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures
Official Title
Effect of Health Habits on Outcomes in Plastic and Reconstructive Surgery
Brief Summary
The purpose of this study is to determine whether a program to optimize patient physical <br /> fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the <br /> abdomen improves surgical outcomes. The investigators hope to determine how a multimodal <br /> peri-operative prehabilitation program can be most effective in engaging and motivating <br /> patients to physically and mentally get ready for an abdominally-based plastic surgery <br /> operation. The overall goal is to determine if this program will improve post-operative <br /> recovery after abdominally-based plastic surgery. The importance of this new knowledge is <br /> better understanding of ways that plastic surgeons can improve outcomes, engagement, and <br /> experience of patients undergoing abdominally-based plastic surgery operations. This would <br /> translate to increased healthcare value and better long-term outcomes.
Treatments and/or Procedures
Prehabilitation program
Nutrition component: Participants will receive information on how to follow a healthy diet (Mediterranean-style diet) with emphasis on whole foods, plants, lean protein, olive oil; restriction of red meats, processed meats, processed foods, added sugar) Exercise component: Participants will receive an activity tracker to use during the study period (3+ weeks before surgery, and 30 days after surgery). Participants will be assigned strength exercises to work on core strength and proximal muscle strength (biceps/triceps, quads, hamstrings, calves).The exercises will mainly be focused on strengthening the abdominal wall. Exercises will be tailored to patients' individual capabilities. They will also be assigned cardio exercises - either low-intensity steady state cardio vs High Intensity Interval training. Level of cardio exercise will be tailored based on patient's Duke Activity score and baseline activity.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Physical Function Test: 6-minute walk test on Post-op 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.
Primary
Physical Function Test: 5-times-sit-to-stand test on Post-op 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.
Primary
Physical Function Test: Timed-up-and-go test on Post-op 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.
Primary
Physical Function Test: Timed-up-and-go test on Post-op 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.
Primary
Occurrence of surgical complications (Post-op day 90)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Primary
Physical Function Test: 6-minute walk test on Post-op 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.
Primary
Occurrence of surgical complications (Post-op days 7-14)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Primary
Occurrence of surgical complications (Post-op day 30)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Primary
Occurrence of surgical complications (Post-op day 180)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Primary
Occurrence of surgical complications (Post-op day 360)
Will analyze the occurrence of surgical complications after surgery. Hematoma, seroma, or abscess.
Primary
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.
Primary
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.
Primary
Physical Function Test: 5-times-sit-to-stand-test on Post-op 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.
Primary
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.
Primary
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.
Primary
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.
Primary
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.
Primary
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.
Primary
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.
Primary
Physical Function Test: 5-times-sit-to-stand test at 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.
Primary
Physical Function Test: 6-minute walk test at 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.
Primary
Physical Function Test: Timed-up-and-go test at 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.
Primary
Physical Function Test: Timed-up-and-go test at 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.
Primary
Physical Function Test: 6-minute walk test at 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.
Primary
Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op 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.
Primary
Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op 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.
Primary
Physical Function Test: 5-times-sit-to-stand test at 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.
Secondary
Change from Baseline Albumin Levels at Time of Surgery
To analyze nutritional status
Secondary
Change from Baseline Prealbumin Levels at Time of Surgery
To analyze nutritional status
Secondary
Change from Baseline Transferrin Levels at Time of Surgery
To analyze nutritional status
Secondary
Change from Baseline C-reactive Protein Levels at Time of Surgery
To analyze level of physiologic inflammation
Secondary
Change from Baseline Erythrocyte Sedimentation Rates at Time of Surgery
To analyze level of physiologic inflammation
Secondary
Change from Baseline Hemoglobin A1C Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Secondary
Change from Baseline Plasma Glucose Levels at Time of Surgery
To analyze degree of diabetes mellitus control
Secondary
Change from Baseline Hemoglobin Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Secondary
Change from Baseline Hematocrit Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Secondary
Change from Baseline Platelet Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Secondary
Change from Baseline Chloride Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Sodium Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Potassium Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Carbon Dioxide Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Blood Urea Nitrogen Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Creatinine Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline Blood Glucose Levels at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of Basic Metabolic Panel
Secondary
Change from Baseline White Blood Cell Count at Time of Surgery
Assessment for leukocytosis, anemia, renal disease; Part of the complete blood count.
Study Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.