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OpenTrials
Completed

NCT Number: NCT00793832

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Supervised exercise

Behavioral

supervised exercise

Diet advice

Behavioral

Diet Advice

Primary outcomes

  1. Exercise at a level sufficient to accumulate at least 2000kcal per week

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2008
Registry last updated
Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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