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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
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 30, 2019
    Last Updated
    June 4, 2019
    Sponsor
    Hospital General Universitario Elche
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    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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