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Exercise in Patients Undergoing Urologic Surgery

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ClinicalTrials.gov Identifier: NCT03954678
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
vmaster
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Perioperative Complication Behavioral: Exercise Group Dietary Supplement: Nutrition Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery
Actual Study Start Date : March 7, 2011
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Group
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
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.

Active Comparator: Nutrition Group
Participants randomized to the nutrition intervention will consume a liquid over-the-counter nutrition supplement two times per day.
Dietary Supplement: Nutrition Group
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.




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    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.

  2. Change in Standing Task Time [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    Participants will be timed, in seconds, to see how quickly they can stand up and sit down in a chair 5 times.

  3. Change in 6 Minute Walk Test (6MWT) Distance [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    The 6 minute walk test (6MWT) assesses distance, in meters, walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance.

  4. Change in grip strength [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    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.

  5. Change in Timed Up and Go (TUG) Task [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    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.

  6. Change in Short-Length Food Frequency Questionnaire [ Time Frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery) ]
    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.


Secondary Outcome Measures :
  1. Perioperative Complications [ Time Frame: 30 days after surgery ]
    The number of perioperative complications will be compared between study arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954678


Contacts
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Contact: Kenneth Ogan, MD (404) 778-4898 kogan@emory.edu

Locations
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United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
vmaster
Investigators
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Principal Investigator: Kenneth Ogan, MD Emory University

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Responsible Party: Kenneth Ogan, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03954678     History of Changes
Other Study ID Numbers: IRB00044694
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Ogan, MD, Emory University:
Exercise
Nutrition supplement
Surgery