Physical Activity Following Surgery Induced Weight Loss

Completed · Not applicable

Conditions studied: Obesity

In brief

The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss. A randomized controlled physical activity intervention trial in a group of patients undergoing bariatric surgery for weight loss. The study will involve two sites with an active bariatric surgery program, which have a strong track record of bariatric surgery research. The study will include 160-200 subjects. Changes in the primary outcome variables will be determined in previous gastric bypass patients as a result of 6 months of moderate physical activity compared to an educational control group not engaged structured exercise.

Key facts

Study ID

NCT00692367

Run by

University of Pittsburgh

People needed

128

Starts

2007-12-01

Expected to finish

2012-11-01

Last updated by the study team

2014-11-04

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women (21-60 years of age) good health, stable weight, and without any contraindication to exercise.

You may not qualify if…

• Anemia (Hct<34%)
• Elevated liver enzyme (25% above normal),
• Proteinuria,
• Hypothyroidism (sTSH > 8)
• Hypertension (blood pressure > 150 mmHg systolic, or > 95 mmHg diastolic)
• Diabetes mellitus (fasting glucose ≥ 126 mg/dl)
• A history of myocardial infarction or peripheral vascular disease
• Liver disease
• Alcohol or drug abuse
• Malignancy or neuromuscular disease
• Subjects will be excluded if taking chronic medications known to adversely affect glucose homeostasis (oral glucocorticoids, nicotinic acid)
• Females currently on hormone replacement therapy (HRT) can participate in the study if they have been on HRT for at least 6 months and will continue to be on HRT during the study.
• Disqualifying findings on physical examination include:
• Lower extremity thrombophlebitis
• Evidence of peripheral neuropathy, paresis or edema.
• If the resting EKG prior to the exercise test shows any abnormalities, the test will not be conducted. If any abnormalities develop during the test, the test will be stopped. On both occasions, the participant will be referred to their PCP for further evaluation and will only be allowed to continue the study with written clearance by his/her PCP or cardiologist. American College of Sports Medicine (ACSM) criteria will be used to halt maximal exercise testing should adverse cardiovascular responses develop. Only after a cardiologist interprets the resting and exercise ECG of the participant and clears them for exercise, will subjects be able to continue with the study

Where it is running

• East Carolina University — Greenville, North Carolina, United States
• Montefiore Hospital, N807 — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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