Exercise in Patients Undergoing Urologic Surgery
ConditionPerioperative Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Group
BehavioralFor the first two days after their pre-operative visit, participants will be asked to continue their present level of exercise and activity, which will be monitored by pedometer. Participants will begin the activity intervention on study Day 3. Participants will be instructed to take 10,000 steps per day, recording their daily steps with a pedometer. Participants also will be provided with resistance bands and instructed on how to safely perform 10 whole-body strength training exercises. They will be instructed to perform the exercises once per day, three days a week. Participants will complete the exercise intervention until they have surgery, which is typically 12 to 48 days after the pre-operative visit.
Nutrition Group
Dietary supplementParticipants in the nutrition group will be provided with a liquid over-the-counter nutrition supplement (i.e. Boost or Ensure) to consume. Participants will be instructed to consume 1 bottle, 2 times per day, beginning 5 days before surgery and continuing 5 days post-operatively.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Exercise GroupExperimental treatment 1 intervention
Group B: Nutrition GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Body Mass Index (BMI)
Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters (kg/m\^2) and used as an indicator of underweight, normal, overweight and obese weights.
Time frame
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)2
Change in Standing Task Time
Participants will be timed, in seconds, to see how quickly they can stand up and sit down in a chair 5 times.
Time frame
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)3
Change in 6 Minute Walk Test (6MWT) Distance
The 6 minute walk test (6MWT) assesses distance, in meters, walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance.
Time frame
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)4
Change in grip strength
Hand grip is measured in pounds using a dynamometer to test the maximum isometric strength of the hand and forearm muscles. Grip strength is a measurement of muscle strength and tends to decline with frail states.
Time frame
Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)Secondary outcomes
1
Perioperative Complications
The number of perioperative complications will be compared between study arms.
Time frame
30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
vmaster
Collaborator
Source ClinicalTrials.gov