Clinical trial NCT04235842: Physical Exercise in Postoperative Bariatric Surgery Patients
Official title: Effects of Physical Exercise in Postoperative Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Physical Exercise
Bariatric Surgery
Morbid Obesity
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, single blinded.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Body fat (%)
timeFrame: 16 weeks
measure: Muscle mass (Kg)
timeFrame: 16 weeks
measure: Bone mass (Kg)
timeFrame: 16 weeks
measure: Heart rate variability
timeFrame: 16 weeks
measure: Six minutes walk test (mts traveled)
timeFrame: 16 weeks
measure: Moorehead-Ardelt Quality of Life Questionnaire (MAQ II)
timeFrame: 16 weeks
measure: Bariatric Analysis and Reporting Outcomes System (BAROS Score)
timeFrame: 16 weeks
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressures (cmH2O)
timeFrame: 16 weeks
measure: Flowmeter (L/min)
timeFrame: 16 weeks
measure: Hand grip strength test (Kg)
timeFrame: 16 weeks
measure: 30-sec chair stand test (count)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Curicó
country: Chile
facility: Hospital San Juan de Dios de Curicó
state: Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Antonio R Zamunér, PhD
role: STUDY_DIRECTOR
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