Clinical trial NCT01722357: Promoting Physical Activity Among Bariatric Surgery Patients
Official title: Promoting Physical Activity Among Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
physical activity
morbid obesity
Lead sponsor: Ascension St. Vincent Carmel Hospital
Sponsor class: OTHER
Collaborators: name: St. Vincent Foundation
First posted: 2012-11-06
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accelerometer-Derived Activity
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Graded Treadmill Test
timeFrame: baseline, 6 months and 5 years post-surgery
measure: Upper Body Strength testing
timeFrame: baseline, 6 months and 5 years post-surgery
measure: Baecke Habitual Physical Activity Questionnaire
timeFrame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: Myers-Roth Benefits and Barriers of Exercise Questionnaire
timeFrame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: PHQ-9 Symptom Checklist
timeFrame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: St.Vincent Exercise Questionnaire
timeFrame: baseline , 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
measure: Exercise Identity Scale
timeFrame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: NEO-IPIP Conscientiousness Scale
timeFrame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: Thoughts of Exercise Scale
timeFrame: 12 and 18 months, and 2, 3, 4, and 5 years post-surgery
measure: Accelerometer-Derived Activity
timeFrame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
Other outcomes:
measure: Vital signs
timeFrame: baseline, 2, 4, 6, 12, and 18 months and 2, 3, 4, and 5 years post-surgery
Locations:
city: Carmel
country: United States
facility: St. Vincent Carmel Hospital Bariatric Center of Excellence
state: Indiana
Study officials:
affiliation: St. Vincent Carmel Hospital Bariatric Center of Excellence
name: David B Creel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Creel DB, Schuh LM, Reed CA, Gomez AR, Hurst LA, Stote J, Cacucci BM. A randomized trial comparing two interventions to increase physical activity among patients undergoing bariatric surgery. Obesity (Silver Spring). 2016 Aug;24(8):1660-8. doi: 10.1002/oby.21548. Epub 2016 Jul 1.
citation: Creel DB, Schuh LM, Newton RL Jr, Stote JJ, Cacucci BM. Exercise Testing Reveals Everyday Physical Challenges of Bariatric Surgery Candidates. J Phys Act Health. 2017 Dec 1;14(12):913-918. doi: 10.1123/jpah.2017-0128. Epub 2017 Oct 12.