Semi-supervised Exercise Program Before Bariatric Surgery

Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients

Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients.

Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients.

Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.

Study Overview

• Status: Unknown
• Conditions: Exercise; Morbid Obesity; Bariatric Surgery
• Intervention / Treatment: Behavioral: Exercise program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 20-55 years.
• All patients awaiting bariatric surgery.

Exclusion Criteria:

• Patients with chronic respiratory diseases
• Patients with cardiovascular diseases
• Inability to perform exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; Three months of semi-supervised exercise program in patients awaiting bariatric surgery. Body composition, cardiovascular risk factors, physical fitness, physical activity levels and quality of life will be assessed before and at the end of the study. In addition, surgery time, hospital length of stay and operative complications also will be evaluated.	Behavioral: Exercise program; Twelve-week of semi-supervised exercise program. The exercise program will combine resistance and endurance training. Both the volume and intensity of training will start at moderate intensity, and progressively be increased at higher volumes and intensities.; Other Names: Exercise program in patients awaiting bariatric surgery.
No Intervention: Control group; The control group only will perform the evaluations of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition - Body mass index	Bioimpedance analysis will be used for establishing body weight and body composition. This variables will be evaluated between 8:00 and 9:00 A.M., after at least 8 hours of fasting, with an empty bladder. Body mass index will be calculated dividing weight in kilograms by squared height in meters. Therefore, body mass index will be expressed as kg·m-2.	Baseline and 3 months, between 8:00 AM and 9:00 AM.
Change in glucose and HbA1c levels.	Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.	Baseline and 3 months, between 8:00 AM and 10:00 AM.
Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.	Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.	Baseline and 3 months, between 8:00 AM and 10:00 AM.
Change in systolic and diastolic blood pressure.	Systolic and Diastolic Blood pressure will be measured according to established recommendations.	Baseline and 3 months, between 8:00 AM and 9:00 AM.
Complications rates	All the complications suffered by patients will be recorded.	Day 30 after surgery.
Length of stay.	The number of days at hospital after bariatric surgery will be recorded.	Day 15 after surgery.
Change in handgrip strength	Strength levels will be assessed using a hand dynamometer.	Baseline and 3 months, between 5:00 PM and 8:00 PM.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physical activity levels.	Levels of physical activity will be measured recording the physical activity performed for 7 days using an accelerometer.	Baseline and 3 months, seven days.
Change in health-related quality of life: sf-36 questionnaire.	The Spanish version of Short Form Health Survey 36 (SF-36) will be used for knowing changes in quality of life. This questionnaire uses 8 scales to evaluate physical health (4 scales: Physical Function, Role Physical, Bodily Pain, General Health) and mental health (4 scales: Vitality, Social functioning, Role Emotional, and Mental Health). The scores of these scales are transformed into values between 0-100 points, where highest scores are related to better function. These 8 scales are grouped into two summary components (physical summary component; mental summary component) which will be calculated according to the reference values of the Spanish population, with a mean of 50 and standard deviation of 10.population.	Baseline and 3 months.
Change in waist and hip circumference.	Waist and hip circumference will be measured in centimeters, using established recommendations.	Baseline and 3 months, between 8:00 AM and 9:00 AM.

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: HRJC-19_Ex.Bar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No