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

NCT ID: NCT00793832

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-06-30

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 endurance activity will increase their physical fitness and total daily energy expenditure compared to the DA group.

Conditions

Post-bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Supervised exercise.

Group Type: ACTIVE_COMPARATOR

supervised exercise

Intervention Type: BEHAVIORAL

supervised exercise

2

Diet Advice

Group Type: ACTIVE_COMPARATOR

Diet advice

Intervention Type: BEHAVIORAL

Diet Advice

Interventions

supervised exercise

supervised exercise

Intervention Type: BEHAVIORAL

Diet advice

Diet Advice

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Abhimanyu Garg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meena Shah, Ph.D

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Other Identifiers

GCRC 837

Identifier Type: -

Identifier Source: org_study_id