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Semi-supervised Exercise Program Before Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03975244
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Exercise Bariatric Surgery Behavioral: Exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Exercise program in patients awaiting bariatric surgery.

No Intervention: Control group
The control group only will perform the evaluations of the study.



Primary Outcome Measures :
  1. Change in body composition - Body mass index [ Time Frame: Baseline and 3 months, between 8:00 AM and 9:00 AM. ]
    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.

  2. Change in glucose and HbA1c levels. [ Time Frame: Baseline and 3 months, between 8:00 AM and 10:00 AM. ]
    Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.

  3. Change in total cholesterol, HDL cholesterol and LDL cholesterol levels. [ Time Frame: Baseline and 3 months, between 8:00 AM and 10:00 AM. ]
    Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.

  4. Change in systolic and diastolic blood pressure. [ Time Frame: Baseline and 3 months, between 8:00 AM and 9:00 AM. ]
    Systolic and Diastolic Blood pressure will be measured according to established recommendations.

  5. Complications rates [ Time Frame: Day 30 after surgery. ]
    All the complications suffered by patients will be recorded.

  6. Length of stay. [ Time Frame: Day 15 after surgery. ]
    The number of days at hospital after bariatric surgery will be recorded.

  7. Change in handgrip strength [ Time Frame: Baseline and 3 months, between 5:00 PM and 8:00 PM. ]
    Strength levels will be assessed using a hand dynamometer.


Secondary Outcome Measures :
  1. Change in physical activity levels. [ Time Frame: Baseline and 3 months, seven days. ]
    Levels of physical activity will be measured recording the physical activity performed for 7 days using an accelerometer.

  2. Change in health-related quality of life: sf-36 questionnaire. [ Time Frame: Baseline and 3 months. ]
    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.

  3. Change in waist and hip circumference. [ Time Frame: Baseline and 3 months, between 8:00 AM and 9:00 AM. ]
    Waist and hip circumference will be measured in centimeters, using established recommendations.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03975244     History of Changes
Other Study ID Numbers: HRJC-19_Ex.Bar
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms