Recruiting

Physical Fitness & Nutrition

Sponsor:

Emory University

Code:

NCT03954678

Conditions

Perioperative Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Group

Nutrition Group

Study Details

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

Study ID

NCT03954678

Start date

Jul 30, 2019

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Nutrition Group

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

Interventions

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.

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

Central Contacts and Locations

Central contacts

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Exercise
  • Nutrition supplement
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-08-20.