Physical Exercise in Postoperative Bariatric Surgery Patients

Status Suspended

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04235842
Study type	Interventional
Source	Universidad Católica del Maule
Contact
Status	Suspended
Phase	N/A
Start date	December 2, 2019
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.