Clinical trial NCT03954678: Exercise in Patients Undergoing Urologic Surgery
Official title: Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perioperative Complication
Keywords: Exercise
Nutrition supplement
Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: vmaster
First posted: 2019-05-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
measure: Change in Standing Task Time
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
measure: Change in 6 Minute Walk Test (6MWT) Distance
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
measure: Change in grip strength
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
measure: Change in Timed Up and Go (TUG) Task
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
measure: Change in Short-Length Food Frequency Questionnaire
timeFrame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)
Secondary outcomes:
measure: Perioperative Complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Ogan, MD
role: PRINCIPAL_INVESTIGATOR
References: