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Clinical Trials/NCT02070354
NCT02070354
Completed
Not Applicable

Physical Fitness and Macro- and Micro- Nutrient Intake in a Morbidly Obese Bariatric Surgery Population

Geisinger Clinic1 site in 1 country73 target enrollmentAugust 2009
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Geisinger Clinic
Enrollment
73
Locations
1
Primary Endpoint
1 Month Post-Operative 6 Min Walk Test
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.

This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.

Detailed Description

This is a two-pronged study. The first phase is a cross-sectional study design meaning each participant will only be tested once. The investigators wish to test patients from each of the groups listed below to determine CR fitness, activity level, and nutrient intake. The investigators wish to determine if any improvements from bariatric surgery can be maintained over a 2-year period following surgery. If this is the case, our next project will be to track the patients recruited at their new visit longitudinally at all of the five time points listed below. 1. New visit with GI Nutrition 2. 1 month prior to bariatric surgery (at the time of the patient's initial visit with the surgeon (6-7 months after their new visit)) 3. 6 months after bariatric surgery 4. 12 months after bariatric surgery 5. 24 months after bariatric surgery

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
March 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA.
  • Ability to perform a 6 Minute Walk Test.
  • Aged 18 through
  • Willingness to receive dietary recall phone calls and accessibility to a telephone.

Exclusion Criteria

  • Patients with severe lung disease requiring oxygen therapy.
  • Pulmonary embolus or pulmonary infarction.
  • Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent).
  • Unstable angina.
  • Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise.
  • Patients with any health reason that limits walking.
  • Patients with a temporary injury that limits walking.
  • Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living.
  • Patients predetermined to be illiterate or incompetent.
  • Patients who are currently pregnant or have been pregnant at any time since bariatric surgery.

Outcomes

Primary Outcomes

1 Month Post-Operative 6 Min Walk Test

Time Frame: 1 Month Post-Operative

6 Min Walk for Distance

6 Month Post-Operative 6 Min Walk Test

Time Frame: 6 Month Post-Operative

6 Min Walk for Distance

12 Month Post-Operative 6 Min Walk Test

Time Frame: 12 Month Post-Operative

6 Min Walk for Distance

24 Month Post-Operative 6 Min Walk Test

Time Frame: 24 Month Post-Operative

6 Min Walk for Distance

Peak Oxygen Uptake (peak VO2)

Time Frame: 36 Month Post-Operative

Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.

Pre-Operative 6 Min Walk Test

Time Frame: Pre-operative

6 Min Walk for Distance

Secondary Outcomes

  • Pre-operatively Physical activity(Pre-operatively)
  • 1 Month Post-Operative Physical activity(1 Month Post-Operative)
  • 6 Month Post-Operative Physical activity(6 Month Post-Operative)
  • 12 Month Post-Operative Physical activity(12 Month Post-Operative)
  • 24 Month Post-Operative Physical activity(24 Month Post-Operative)
  • 36 Month Post-Operative Physical activity(36 Month Post-Operative)

Study Sites (1)

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