Semi-supervised Exercise Program Before Bariatric Surgery

NCT ID: NCT03975244

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-11-30

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.

Conditions

Morbid Obesity; Exercise; Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise program

Intervention Type: BEHAVIORAL

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.

Control group

The control group only will perform the evaluations of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise program in patients awaiting bariatric surgery.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Elche

OTHER

Sponsor Role: lead

Responsible Party

Jaime Ruiz-Tovar, MD, PhD

Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HRJC-19_Ex.Bar

Identifier Type: -

Identifier Source: org_study_id