Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03954678
Other study ID # IRB00044694
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 30, 2019
Est. completion date June 2025

Study information

Verified date July 2023
Source Emory University
Contact Kenneth Ogan, MD
Phone (404) 778-4898
Email kogan@emory.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University vmaster

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 Perioperative Complications The number of perioperative complications will be compared between study arms. 30 days after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT04167410 - Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery N/A
Terminated NCT04506372 - Management of Angiotensin Inhibitors During the Perioperative Period N/A
Completed NCT04006106 - Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping (ENDOPHEN)
Recruiting NCT06065137 - Standardised Drug Provocation Testing in Perioperative Hypersensitivity N/A
Completed NCT06203171 - Preoperative Evaluation on Perioperative Complications
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Not yet recruiting NCT06279000 - Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery Phase 3
Completed NCT02958293 - Perioperative Morbidity in Elective Surgery Based on the Time of the Year
Recruiting NCT04120012 - The Effect of Frailty to Perioperative Complications in the Elderly
Completed NCT04665349 - Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments N/A
Recruiting NCT04266574 - BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study N/A
Recruiting NCT04256798 - Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery Phase 3
Completed NCT04260334 - Preoperative Care In Ovarian Cancer Patients N/A
Recruiting NCT05533112 - Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia N/A
Completed NCT06097052 - Hypotension Predictive Index Effect on Intraoperative Hypotension During Pancreatic Surgery.
Recruiting NCT06035627 - The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
Not yet recruiting NCT06326528 - SGLT2 Inhibitors and Perioperative Period
Recruiting NCT04347772 - Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery N/A
Completed NCT03974321 - Intraoperative Hypotension and Perioperative Myocardial Injury