Promoting Physical Activity Among Bariatric Surgery Patients

Ascension St. Vincent Carmel Hospital

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Pedometer; Behavioral: Exercise Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01722357

09110

Details and patient eligibility

About

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.

Full description

Bariatric surgery leads to improvement or resolution of a variety of health conditions. It is also well established that physical activity, with or without weight loss, improves many health-related problems and can have a positive impact on mood. Therefore, physical activity may amplify the health and psychological benefits often experienced from bariatric surgery. Prior to surgery many patients are relatively inactive due to physical and social barriers associated with their weight. In addition, many patients find it difficult to adopt an active lifestyle after surgery, despite an increased capacity to exercise. However, weight loss is associated with physical activity after bariatric surgery. Nonetheless, little is known about the most effective means to promote activity among this group of individuals. This study will examine changes in physical activity and fitness after bariatric surgery and examine whether the addition of pedometer use and exercise counseling may lead to greater improvements.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

Pedometer + Exercise Counseling

Experimental group

Treatment:

Behavioral: Exercise Counseling

Behavioral: Pedometer

Pedometer

Experimental group

Treatment:

Behavioral: Pedometer

Usual Care

No Intervention group

Description:

Self-help information provided on physical activity (WIN:Weight Control Network "Active At Any Size" provided by National Institute of Diabetes and Digestive and Kidney Diseases, 2006).