Exercise in Patients Undergoing Urologic Surgery

Emory University

Status: Enrolling

Conditions: Perioperative Complication

Treatments: Dietary Supplement: Nutrition Group; Behavioral: Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03954678

IRB00044694

Details and patient eligibility

About

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

Full description

Increases in physical activity and nutritional status are associated with improvements in a number of health conditions, including coronary artery disease, hypertension, stroke, insulin sensitivity, osteoporosis, and depression. Regretfully, despite the evidence supporting the benefits of physical activity, greater than half of adults in the United States do not get adequate activity and approximately one quarter do not get any activity. As such, many people, especially the elderly and those with comorbid diseases, have low levels of physical fitness. Additionally, up to 45% of community dwelling older adults are malnourished. Patients undergoing surgery with poor exercise tolerance and suboptimal nutritional status may be at an increased risk of perioperative complications. Thus, increasing physical activity and dietary intake quality prior to surgery is recommended, to hopefully decrease these risks. The primary objective is to determine if recommended physical activity or dietary intake results in an increase in patient physical function performance and if so, to what extent. The secondary goal is to examine if increased exercise or nutrition reduces perioperative complications.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for operative procedure with an inpatient postoperative stay are eligible for this study
• Patients willing and able to give blood sample as part of standard of care labs
• Patients willing and able to fill out questionnaire
• Patients who will fill out the step log daily
• Patients willing and able to sign informed consent

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Exercise Group

Experimental group

Description:

Participants randomized to the activity intervention will aim for taking 10,000 steps per day and completing strength training exercises three times per week.

Treatment:

Behavioral: Exercise Group

Nutrition Group

Active Comparator group

Description:

Participants randomized to the nutrition intervention will consume a liquid over-the-counter nutrition supplement two times per day.

Treatment:

Dietary Supplement: Nutrition Group