Semi-supervised Exercise Program Before Bariatric Surgery
Primary Purpose
Morbid Obesity, Exercise, Bariatric Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control group
Arm Description
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.
The control group only will perform the evaluations of the study.
Outcomes
Primary Outcome Measures
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.
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.
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.
Change in systolic and diastolic blood pressure.
Systolic and Diastolic Blood pressure will be measured according to established recommendations.
Complications rates
All the complications suffered by patients will be recorded.
Length of stay.
The number of days at hospital after bariatric surgery will be recorded.
Change in handgrip strength
Strength levels will be assessed using a hand dynamometer.
Secondary Outcome Measures
Change in physical activity levels.
Levels of physical activity will be measured recording the physical activity performed for 7 days using an accelerometer.
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.
Change in waist and hip circumference.
Waist and hip circumference will be measured in centimeters, using established recommendations.
Full Information
NCT ID
NCT03975244
First Posted
May 30, 2019
Last Updated
June 4, 2019
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT03975244
Brief Title
Semi-supervised Exercise Program Before Bariatric Surgery
Official Title
Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Exercise, Bariatric Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group only will perform the evaluations of the study.
Intervention Type
Behavioral
Intervention Name(s)
Exercise program
Other Intervention Name(s)
Exercise program in patients awaiting bariatric surgery.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body composition - Body mass index
Description
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.
Time Frame
Baseline and 3 months, between 8:00 AM and 9:00 AM.
Title
Change in glucose and HbA1c levels.
Description
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Time Frame
Baseline and 3 months, between 8:00 AM and 10:00 AM.
Title
Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.
Description
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Time Frame
Baseline and 3 months, between 8:00 AM and 10:00 AM.
Title
Change in systolic and diastolic blood pressure.
Description
Systolic and Diastolic Blood pressure will be measured according to established recommendations.
Time Frame
Baseline and 3 months, between 8:00 AM and 9:00 AM.
Title
Complications rates
Description
All the complications suffered by patients will be recorded.
Time Frame
Day 30 after surgery.
Title
Length of stay.
Description
The number of days at hospital after bariatric surgery will be recorded.
Time Frame
Day 15 after surgery.
Title
Change in handgrip strength
Description
Strength levels will be assessed using a hand dynamometer.
Time Frame
Baseline and 3 months, between 5:00 PM and 8:00 PM.
Secondary Outcome Measure Information:
Title
Change in physical activity levels.
Description
Levels of physical activity will be measured recording the physical activity performed for 7 days using an accelerometer.
Time Frame
Baseline and 3 months, seven days.
Title
Change in health-related quality of life: sf-36 questionnaire.
Description
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.
Time Frame
Baseline and 3 months.
Title
Change in waist and hip circumference.
Description
Waist and hip circumference will be measured in centimeters, using established recommendations.
Time Frame
Baseline and 3 months, between 8:00 AM and 9:00 AM.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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Semi-supervised Exercise Program Before Bariatric Surgery
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