Semi-supervised Exercise Program Before Bariatric Surgery

NCT03975244 | Unknown

• 1 other identifier: HRJC-19_Ex.Bar
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

• 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.

  Baseline and 3 months, between 8:00 AM and 10:00 AM.

• 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.

  Baseline and 3 months, between 8:00 AM and 10:00 AM.

• Change in systolic and diastolic blood pressure.

  Systolic and Diastolic Blood pressure will be measured according to established recommendations.

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

• Complications rates

  All the complications suffered by patients will be recorded.

  Day 30 after surgery.

• Length of stay.

  The number of days at hospital after bariatric surgery will be recorded.

  Day 15 after surgery.

• Change in handgrip strength

  Strength levels will be assessed using a hand dynamometer.

  Baseline and 3 months, between 5:00 PM and 8:00 PM.

Secondary Outcomes (3)

• Change in physical activity levels.

  Baseline and 3 months, seven days.

• Change in health-related quality of life: sf-36 questionnaire.

  Baseline and 3 months.

• Change in waist and hip circumference.

  Baseline and 3 months, between 8:00 AM and 9:00 AM.

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Exercise program 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.

Also known as: Exercise program in patients awaiting bariatric surgery.

Exercise group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20-55 years.
• All patients awaiting bariatric surgery.

You may not qualify if:

• Patients with chronic respiratory diseases
• Patients with cardiovascular diseases
• Inability to perform exercise

Sponsors & Collaborators

• Hospital General Universitario Elche: lead

MeSH Terms

Conditions

Obesity, Morbid; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Surgery

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: September 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: November 30, 2020
• Last Updated: June 5, 2019

Record last verified: 2019-05