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

Post-bariatric Surgery Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793832
• Other study ID #: GCRC 837
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: June 27, 2013
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-bariatric Surgery

Intervention

Behavioral:
• supervised exercise
supervised exercise
• Diet advice
Diet Advice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise at a level sufficient to accumulate at least 2000kcal per week		12 weeks	No
Secondary	To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups.		12 weeks	No