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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00793832
First received: November 17, 2008
Last updated: November 18, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention
Post-Bariatric Surgery
 Behavioral: supervised exercise
Behavioral: Diet advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Exercise at a level sufficient to accumulate at least 2000kcal per week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Supervised exercise.
 Behavioral: supervised exercise
supervised exercise
Active Comparator: 2
Diet Advice
 Behavioral: Diet advice
Diet Advice

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793832

Contacts
Contact: Sneha Rao, M.B;B.S 214-648-0548 sneha.rao@utsouthwestern.edu
Contact: Meena Shah, Ph.D 214-648-0543 meena.shah@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Meena Shah, Ph.D            
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Meena Shah, Ph.D UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Abhimanyu Garg, M.D., UT Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00793832     History of Changes
Other Study ID Numbers: GCRC 837
Study First Received: November 17, 2008
Last Updated: November 18, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013