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The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00793832
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : July 1, 2013
Information provided by (Responsible Party):
Abhimanyu Garg, University of Texas Southwestern Medical Center

Brief Summary:
It is hypothesized that the patients in the EXDA group will be able to complete a structured exercise program at a level sufficient to accumulate at least 2000 kcal per week, and that the structured endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.

Condition or disease Intervention/treatment
Post-bariatric Surgery Behavioral: supervised exercise Behavioral: Diet advice

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Supervised Cardiorespiratory Endurance Exercise Training on Physical Fitness and Energy Expenditure in Roun-en-Y Gastric Bypass and Gastric Banding Surgery Patients.
Study Start Date : July 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Supervised exercise.
Behavioral: supervised exercise
supervised exercise
Active Comparator: 2
Diet Advice
Behavioral: Diet advice
Diet Advice

Primary Outcome Measures :
  1. Exercise at a level sufficient to accumulate at least 2000kcal per week [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups. [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. RYGB or GB surgery patients who are at least 12 weeks post surgery
  2. BMI of 40 or more
  3. age 18-70years
  4. sedentary lifestyle (energy expenditure of <35 kcal/kg/day measured by 7-day physical activity recall and no regular moderate physical activity exceeding 20 min/day within the previous 3 months)
  5. willingness to alter physical activity in accordance with the intervention programs
  6. English or Spanish speaking.

Exclusion Criteria:

  1. body weight > 180 kg
  2. cardiovascular disease
  3. pulmonary disease
  4. uncontrolled hypertension (resting DBP >100 or SBP >180 mm of Hg)
  5. visual or hearing impairment
  6. functional limitations (difficulty walking one-quarter mile or climbing 10 stairs)
  7. abnormal ECG on VO2max test ( >1 mm ST segment depression at < 5 METS or with symptoms such as atrial fibrillation, complex ventricular arrhythmias and 3rd degree atrioventricular block)
  8. known liver disease due to causes other than nonalcoholic steatohepatitis (liver transaminases > 2.5 times the upper limits of normal [SGPT>105 U/L, SGPT>120 U/L] or total bilirubin >1.5 mg/dL)
  9. hematocrit of less than 30%
  10. current alcohol abuse (>7 drinks or 210 g/wk for women and >14 drinks or 420 g/wk for men)
  11. recreational drug abuse
  12. current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.)
  13. major neuro-psychiatric illnesses impeding competence or compliance
  14. pregnancy and lactation
  15. chronic renal insufficiency (serum creatinine > 2 mg/dL)
  16. untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications including anastomotic leak, wound complications, thrombotic disorders, intestinal obstruction, stomal complications, GI bleeding, recurrent severe abdominal pain, bilious vomiting.

Information from the National Library of Medicine

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): NCT00793832

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Meena Shah, Ph.D UT Southwestern Medical Center

Responsible Party: Abhimanyu Garg, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00793832     History of Changes
Other Study ID Numbers: GCRC 837
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: January 2010

Keywords provided by Abhimanyu Garg, University of Texas Southwestern Medical Center:
weight loss