Physical Exercise in Postoperative Bariatric Surgery Patients
- Conditions
- Morbid ObesityPhysical ExerciseBariatric Surgery
- Interventions
- Other: Physical ExerciseOther: High-intensity interval training performed at cycle ergometer.
- Registration Number
- NCT04235842
- Lead Sponsor
- Universidad Católica del Maule
- Brief Summary
This study aims to determine the effect of two types of exercise training on body composition, cardiopulmonary function and quality of life in people after undergoing bariatric surgery.
- Detailed Description
Three groups will be studied:
1. Control group (CG)
2. Group of moderate intensity continuous aerobic exercise (GMICT)
3. High intensity interval aerobic exercise group (GHIIT)
The CG will follow the usual protocol adopted by the hospital San Juan de Dios, Curicó, Chile. The protocol consists in delivering information about relevance of engage in regular physical exercise practice according to the World Health Organization (150 minutes of activity per week moderate physical or at least 75 minutes of intense physical activity), but do not include the patients in a supervised physical exercise program.
The GMICT will undergo a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training (60% of the heart rate reserve).
The GHIIT will undergo the same exercise program of the GMICT, but the aerobic component will be a high-intensity interval exercise training (10 sets of 1 min at 90% of heart rate reserve, with 1 min of rest between sets).
All groups will receive a nutritional diet plan prescribed by a specialist bariatric nutritionist blinded to the participants group assignment.
At the end of the study, the CG will be invited to enjoy the exercise program showing to be more effective.
Outcomes will be assessed at four time points: 1) one week before surgery; 2) 21 days after surgery (baseline before start exercise program); 3) 8 weeks after the beginning of the exercise program; and 4) one week after the end of intervention.
Main outcomes are: 1) body composition; 2) heart rate variability; 3) six-minute walk test and 4) quality of life. Secondary outcomes will be: 1) maximal respiratory pressures; 2) flowmeter; 3) dynamometry of upper limb; and 4) squat test in 30 seconds.
All procedures will be performed in the Hospital of Curicó, Chile, at the Department of Physical Medicine and Rehabilitation Service.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 75
- Persons between 18 and 65 years old, both sexes, who have undergone bariatric surgery, with medical authorization to perform physical exercise, that the wound healing process operative is in the final phase, which have been administered with subsequent anti thrombus treatment to surgery, who have no plans to change their place of residence within the current year.
- Persons who have had immediate complications after bariatric surgery (dehiscence anastomosis and operative wound dehiscence), presented any comorbidity decompensation after surgery, who are in the process of dialysis or who suffer from neuromotor disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate-intensity continuous exercise training group (GMICT) Physical Exercise The GMICT will be submitted to a physical exercise program in which the aerobic component will be a moderate-intensity continuous exercise training, performed at 60% of the heart rate reserve, two days a week, for 30 minutes. High-intensity interval training exercise group (GHIIT) High-intensity interval training performed at cycle ergometer. The GHIIT will be will be submitted to a physical exercise program in which the aerobic component will be a high-intensity interval exercise training, performed in a protocol consisted of four one-min sprint at 90% of the heart rate reserve, alternated with one-min rest (at week 1) and progressing until reach 10 bouts of one-min sprint alternated with one-min rest.
- Primary Outcome Measures
Name Time Method Bone mass (Kg) 16 weeks To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance.
Six minutes walk test (mts traveled) 16 weeks To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test.
Body fat (%) 16 weeks To determine the effects of HIIT and MCIT on body composition by measuring percent of body fat using a tetrapolar bioelectrical impedance.
Muscle mass (Kg) 16 weeks To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance.
Moorehead-Ardelt Quality of Life Questionnaire (MAQ II) 16 weeks To determine the effects of HIIT and MCIT on quality of life by the Moorehead-Ardelt Quality of Life Questionnaire. The score of each answer ranges from -0.5 (most unfavorable situation) to +0.5 (most favorable situation). According to the score obtained: -3 to -2.1: "very poor"; -2 to -1.1: "poor"; -1 to 1: "fair"; 1.1 to 2: "good"; and 2.1 to 3: "very good" quality of life.
Heart rate variability 16 weeks To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.
Bariatric Analysis and Reporting Outcomes System (BAROS Score) 16 weeks To determine the effects of HIIT and MCIT on quality of life by the Bariatric Analysis and Reporting Outcomes System. Moorehead-Ardelt questionnaire incorporates the percentage of overweight lost or gained after surgery, resolution of comorbidities associated with morbid obesity, need for reoperation and complications. According to the score obtained, it is categorized as: ≤1: "failure"; \> 1 to 3: "fair"; \> 3 to 5: "good"; \> 5 to 7: "very good"; and \> 7 to 9: excellent.
- Secondary Outcome Measures
Name Time Method Flowmeter (L/min) 16 weeks To determine the effects of HIIT and MCIT on the peak expiratory flow.
Hand grip strength test (Kg) 16 weeks To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured.
30-sec chair stand test (count) 16 weeks To determine the effects of HIIT and MCIT on cardiopulmonary function the number of squats in 30 seconds will be counted.
Maximal inspiratory and expiratory pressures (cmH2O) 16 weeks To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures.
Trial Locations
- Locations (1)
Hospital San Juan de Dios de Curicó
🇨🇱Curicó, Maule, Chile