Promoting Physical Activity Among Bariatric Surgery Patients
Completed · Not applicable
Conditions studied: Obesity
In brief
The purpose of the study is to address 3 main sets of questions in the bariatric surgery population. 1) Does bariatric surgery, without any other intervention, lead to increased physical activity and improved physical fitness? 2) Does wearing a pedometer lead to increased physical activity in obese individuals prior to and/or after bariatric surgery? Does the increased activity result in improvements in physical fitness? 3) Does physical activity counseling increase physical activity prior to and or/after bariatric surgery? Does the increased activity result in improvements in physical fitness? The overall goal of the study is to determine the impact of bariatric surgery on physical activity and assess the utility of additional interventions to help postoperative patients adopt a more active lifestyle. Participants are randomized to usual care, pedometer use, or pedometer use plus exercise counseling before and for the first 6 months after bariatric surgery. In an extension of the primary study, from 1 to 5 years after surgery, all patients receive exercise counseling. Physiological measures will be assessed to determine whether bariatric surgery and/or improved physical activity levels result in improved physical fitness.
Key facts
- Study ID
- NCT01722357
- Run by
- Ascension St. Vincent Carmel Hospital
- People needed
- 152
- Starts
- 2009-11-01
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2020-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Morbidly obese patients planning to undergo bariatric surgery at the St. Vincent Bariatric Center of Excellence
- Men and women 18 years and older
- The participant must be motivated to enroll in a study assessing physical activity before and after bariatric surgery, able to understand and comply with the study, and must agree to return for scheduled visits
- All participants must sign a written, informed consent
You may not qualify if…
- History of myocardial infarction within the past three months, unstable angina pectoris, sustained or episodic cardiac arrhythmias that could be aggravated by physical activity, symptomatic peripheral vascular disease, or any other medical condition that the medically responsible investigator deems inappropriate.
- Abnormal electrocardiogram (ECG), assessed at the pretreatment screening visit that the medically responsible investigator deems inappropriate for participation in a physical activity program.
- Unable to progress toward 30 minutes of continuous walking during the 6 months of study participation.
Where it is running
- St. Vincent Carmel Hospital Bariatric Center of Excellence — Carmel, Indiana, United States
Full record on ClinicalTrials.gov
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