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 : June 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Perioperative Complication||Behavioral: Exercise Group Dietary Supplement: Nutrition Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery|
|Actual Study Start Date :||March 7, 2011|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Perioperative Complications [ Time Frame: 30 days after surgery ]The number of perioperative complications will be compared between study arms.
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
|Contact: Kenneth Ogan, MD||(404) firstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kenneth Ogan, MD||Emory University|