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

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.

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.

Study Overview

• Status: Completed
• Conditions: Post-bariatric Surgery
• Intervention / Treatment: Behavioral: supervised exercise; Behavioral: Diet advice

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Supervised exercise.	Behavioral: supervised exercise; supervised exercise
Active Comparator: 2; Diet Advice	Behavioral: Diet advice; Diet Advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exercise at a level sufficient to accumulate at least 2000kcal per week	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare body weight and composition, quality of life, fasting lipids and lipoproteins, and glycemic control between the two groups.	12 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Meena Shah, Ph.D, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 18, 2008
• First Posted (Estimate): November 19, 2008

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: weight loss
• Other Study ID Numbers: GCRC 837