Perioperative ComplicationNCT03954678
Exercise in Patients Undergoing Urologic Surgery
A study testing Exercise Group and Nutrition Group in people with Perioperative Complication, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- Exercise Group and Nutrition Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery
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.
Read the 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.
- Conditions
- Perioperative Complication
- Being tested
- Exercise Group, Nutrition Group
- Keywords
- Exercise, Nutrition supplement, Surgery
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupBehavioural
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.
Nutrition GroupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Nutrition Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start30 Jul 2019
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- vmaster
- Responsible party
- Principal investigator, Kenneth Ogan, Emory University
- Investigators
- Kenneth Ogan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954678
- Sponsor's protocol ID
- IRB00044694
- Status last verified
- Aug 2026
- First submitted
- 16 May 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery
- ClinicalTrials.gov ID
- NCT03954678
- Acronym / sponsor ID
- IRB00044694
- Conditions
- Perioperative Complication
- Keywords
- Exercise, Nutrition supplement, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- vmaster
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Exercise GroupParticipants randomized to the activity intervention will aim for taking 10,000 steps per day and completing strength training exercises three times per week. |
| Nutrition Group | Active comparator | Dietary Supplement: Nutrition GroupParticipants randomized to the nutrition intervention will consume a liquid over-the-counter nutrition supplement two times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise GroupFor 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. | Behavioural | Exercise Group |
| Nutrition GroupParticipants 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. | Dietary supplement | Nutrition Group |
Primary outcome
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.
1 secondary outcome
Perioperative Complications
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Ogan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group and Nutrition Group in people with Perioperative Complication, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Ogan, MD ((404) 778-4898, kogan@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.