Exercise in Patients Undergoing Urologic Surgery

NCT03954678 | Recruiting DMC

• 1 other identifier: IRB00044694
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Complication

Keywords

Exercise; Nutrition supplement; Surgery

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

• 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.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

• 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.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

• 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.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

• Change in Timed Up and Go (TUG) Task

  Participants will be timed, in seconds, to see how quickly they can rise from a chair, walk 3 meters, turn around, walk back, and sit down.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

• Change in Short-Length Food Frequency Questionnaire

  Nutritional risk will be assessed with the Short-Length Food Frequency Questionnaire. This 18-item instrument asks participants how frequently they consume certain foods, such as alcohol, produce, grains, and fried foods. There is not a summary score for this questionnaire, rather, the researchers can examine changes over time in foods consumed in a variety of ways.

  Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)

Secondary Outcomes (1)

• Perioperative Complications

  30 days after surgery

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Behavioral: Exercise Group

Nutrition Group

ACTIVE COMPARATOR

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

Dietary Supplement: Nutrition Group

Interventions

Exercise Group BEHAVIORAL

For 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.

Exercise Group

Nutrition Group DIETARY_SUPPLEMENT

Participants 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.

Nutrition Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead
• vmaster: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kenneth Ogan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Ogan, MD

CONTACT

(404) 778-4898; kogan@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 17, 2019
• Study Start: July 30, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)