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Due to COVID-19, bariatric surgeries has been suspended and the center where the study was being developed suspended this research.
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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.
Three groups will be studied:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (CG) | No Intervention | The CG will receive the standard indications routinely provided by the hospital which consists in information about practice of regular physical activity according to World Health Organization. A leaflet with illustrations and indications will be provided and will be explained by the principal investigator. | |
| Moderate-intensity continuous exercise training group (GMICT) | Experimental | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise | Other | Moderate-intensity continuous exercise training performed at cycle ergometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body fat (%) | To determine the effects of HIIT and MCIT on body composition by measuring percent of body fat using a tetrapolar bioelectrical impedance. | 16 weeks |
| Muscle mass (Kg) | To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance. | 16 weeks |
| Bone mass (Kg) | To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance. | 16 weeks |
| Heart rate variability | To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions. | 16 weeks |
| Six minutes walk test (mts traveled) | To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test. | 16 weeks |
| Moorehead-Ardelt Quality of Life Questionnaire (MAQ II) | 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. | 16 weeks |
| Bariatric Analysis and Reporting Outcomes System (BAROS Score) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal inspiratory and expiratory pressures (cmH2O) | To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures. | 16 weeks |
| Flowmeter (L/min) | To determine the effects of HIIT and MCIT on the peak expiratory flow. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio R Zamunér, PhD | Universidad Católica del Maule | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Juan de Dios de Curicó | Curicó | Maule Region | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25929372 | Background | Alcaraz Garcia AM, Ferrer Marquez M, Parron Carreno T. [Quality of life in obese patients and change after bariatric surgery medium and long term]. Nutr Hosp. 2015 May 1;31(5):2033-46. doi: 10.3305/nh.2015.31.5.8792. Spanish. | |
| 22732956 | Background | Amaya Garcia MJ, Vilchez Lopez FJ, Campos Martin C, Sanchez Vera P, Pereira Cunill JL. [Micronutrients in bariatric surgery]. Nutr Hosp. 2012 Mar-Apr;27(2):349-61. doi: 10.1590/S0212-16112012000200004. Spanish. |
| Label | URL |
|---|---|
| Selection of candidates for bariatric surgery | View source |
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In order to protect the privacy, data will be stored and coded. At the end of the study, data may be available upon a reasonable request and ensuring the participants' data confidentiality will be preserved.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Randomized clinical trial, single blinded.
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The outcomes assessor will be blinded to the study intervention the participants were submitted.
| High-intensity interval training performed at cycle ergometer. | Other | High-intensity interval training performed at cycle ergometer. |
|
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. |
| 16 weeks |
| 16 weeks |
| Hand grip strength test (Kg) | To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured. | 16 weeks |
| 30-sec chair stand test (count) | To determine the effects of HIIT and MCIT on cardiopulmonary function the number of squats in 30 seconds will be counted. | 16 weeks |
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| 25929369 | Background | Delgado Floody P, Caamano Navarrete F, Jerez Mayorga D, Campos Jara C, Ramirez Campillo R, Osorio Poblete A, Alarcon Hormazabal M, Thuillier Lepeley N, Saldivia Mansilla C. [Effects of a multidisciplinary program on morbid obese patients and patients with comorbility who are likely to be candidates for bariatric surgery]. Nutr Hosp. 2015 May 1;31(5):2011-6. doi: 10.3305/nh.2015.31.5.8569. Spanish. |
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| 23848081 | Background | Papapietro K, Massardo T, Riffo A, Diaz E, Araya AV, Adjemian D, Montesinos G, Castro G. [Bone mineral density disminution post Roux-Y bypass surgery]. Nutr Hosp. 2013 May-Jun;28(3):631-6. doi: 10.3305/nh.2013.28.3.6400. Spanish. |
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| 33522950 | Derived | Herrera-Santelices A, Tabach-Apraiz A, Andaur-Caceres K, Zamuner AR. Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial. Trials. 2021 Feb 1;22(1):107. doi: 10.1186/s13063-021-05056-4. |
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| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |