Status:
COMPLETED
Physical Activity Following Surgery Induced Weight Loss
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
East Carolina University
Conditions:
Obesity
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
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 interve...
Detailed Description
The primary objective of this study will be to determine the effects of physical activity in patients during substantial surgery-induced weight loss. We propose to employ a randomized controlled physi...
Eligibility Criteria
Inclusion
- Men and women (21-60 years of age) good health, stable weight, and without any contraindication to exercise.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00692367
Start Date
December 1 2007
End Date
November 1 2012
Last Update
November 4 2014
Active Locations (2)
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1
East Carolina University
Greenville, North Carolina, United States, 27858
2
Montefiore Hospital, N807
Pittsburgh, Pennsylvania, United States, 15213