Status:
COMPLETED
The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Post-bariatric Surgery
Eligibility:
All Genders
18-70 years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- RYGB or GB surgery patients who are at least 12 weeks post surgery
- BMI of 40 or more
- age 18-70years
- 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)
- willingness to alter physical activity in accordance with the intervention programs
- English or Spanish speaking.
Exclusion
- body weight \> 180 kg
- cardiovascular disease
- pulmonary disease
- uncontrolled hypertension (resting DBP \>100 or SBP \>180 mm of Hg)
- visual or hearing impairment
- functional limitations (difficulty walking one-quarter mile or climbing 10 stairs)
- 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)
- 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)
- hematocrit of less than 30%
- current alcohol abuse (\>7 drinks or 210 g/wk for women and \>14 drinks or 420 g/wk for men)
- recreational drug abuse
- current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.)
- major neuro-psychiatric illnesses impeding competence or compliance
- pregnancy and lactation
- chronic renal insufficiency (serum creatinine \> 2 mg/dL)
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00793832
Start Date
July 1 2007
End Date
June 1 2009
Last Update
July 1 2013
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