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

NCT00793832 | Completed

• 1 other identifier: GCRC 837
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Keywords

weight loss

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Supervised exercise.

Behavioral: supervised exercise

2

ACTIVE COMPARATOR

Diet Advice

Behavioral: Diet advice

Interventions

supervised exercise BEHAVIORAL

supervised exercise

1

Diet advice BEHAVIORAL

Diet Advice

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Weight Loss

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Meena Shah, Ph.D

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 1, 2013

Record last verified: 2010-01