Clinical trial NCT03975244: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Exercise
Bariatric Surgery
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in body composition - Body mass index
timeFrame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
measure: Change in glucose and HbA1c levels.
timeFrame: Baseline and 3 months, between 8:00 AM and 10:00 AM.
measure: Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.
timeFrame: Baseline and 3 months, between 8:00 AM and 10:00 AM.
measure: Change in systolic and diastolic blood pressure.
timeFrame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
measure: Complications rates
timeFrame: Day 30 after surgery.
measure: Length of stay.
timeFrame: Day 15 after surgery.
measure: Change in handgrip strength
timeFrame: Baseline and 3 months, between 5:00 PM and 8:00 PM.
Secondary outcomes:
measure: Change in physical activity levels.
timeFrame: Baseline and 3 months, seven days.
measure: Change in health-related quality of life: sf-36 questionnaire.
timeFrame: Baseline and 3 months.
measure: Change in waist and hip circumference.
timeFrame: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Other outcomes:
Locations:
Study officials:
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