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Physical Exercise in Postoperative Bariatric Surgery Patients

Primary Purpose

Physical Exercise, Bariatric Surgery, Morbid Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Physical Exercise

High-intensity interval training performed at cycle ergometer.

About this trial

This is an interventional treatment trial for Physical Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital San Juan de Dios de CuricóRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control Group (CG)

Moderate-intensity continuous exercise training group (GMICT)

High-intensity interval training exercise group (GHIIT)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Body fat (%)

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)

To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance.

Bone mass (Kg)

To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance.

Heart rate variability

To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.

Six minutes walk test (mts traveled)

To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test.

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.

Bariatric Analysis and Reporting Outcomes System (BAROS Score)

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

Maximal inspiratory and expiratory pressures (cmH2O)

To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures.

Flowmeter (L/min)

To determine the effects of HIIT and MCIT on the peak expiratory flow.

Hand grip strength test (Kg)

To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured.

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.

Full Information

NCT ID

NCT04235842

First Posted

January 16, 2020

Last Updated

January 12, 2021

Sponsor

Universidad Católica del Maule

1. Study Identification

Unique Protocol Identification Number

NCT04235842

Brief Title

Physical Exercise in Postoperative Bariatric Surgery Patients

Official Title

Effects of Physical Exercise in Postoperative Bariatric Surgery Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2, 2019 (Actual)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Católica del Maule

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: Control group (CG) Group of moderate intensity continuous aerobic exercise (GMICT) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Exercise, Bariatric Surgery, Morbid Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial, single blinded.

Masking

Outcomes Assessor

Masking Description

The outcomes assessor will be blinded to the study intervention the participants were submitted.

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group (CG)

Arm Type

No Intervention

Arm Description

Arm Title

Moderate-intensity continuous exercise training group (GMICT)

Arm Type

Experimental

Arm Description

Arm Title

High-intensity interval training exercise group (GHIIT)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Physical Exercise

Intervention Description

Moderate-intensity continuous exercise training performed at cycle ergometer.

Intervention Type

Other

Intervention Name(s)

High-intensity interval training performed at cycle ergometer.

Intervention Description

High-intensity interval training performed at cycle ergometer.

Primary Outcome Measure Information:

Title

Body fat (%)

Description

To determine the effects of HIIT and MCIT on body composition by measuring percent of body fat using a tetrapolar bioelectrical impedance.

Time Frame

16 weeks

Title

Muscle mass (Kg)

Description

To determine the effects of HIIT and MCIT on body composition by measuring muscle mass using a tetrapolar bioelectrical impedance.

Time Frame

16 weeks

Title

Bone mass (Kg)

Description

To determine the effects of HIIT and MCIT on body composition by measuring bone mass using a tetrapolar bioelectrical impedance.

Time Frame

16 weeks

Title

Heart rate variability

Description

To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.

Time Frame

16 weeks

Title

Six minutes walk test (mts traveled)

Description

To determine the effects of HIIT and MCIT on functional capacity using the six-minute walk test.

Time Frame

16 weeks

Title

Moorehead-Ardelt Quality of Life Questionnaire (MAQ II)

Description

Time Frame

16 weeks

Title

Bariatric Analysis and Reporting Outcomes System (BAROS Score)

Description

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Maximal inspiratory and expiratory pressures (cmH2O)

Description

To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures.

Time Frame

16 weeks

Title

Flowmeter (L/min)

Description

To determine the effects of HIIT and MCIT on the peak expiratory flow.

Time Frame

16 weeks

Title

Hand grip strength test (Kg)

Description

To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured.

Time Frame

16 weeks

Title

30-sec chair stand test (count)

Description

To determine the effects of HIIT and MCIT on cardiopulmonary function the number of squats in 30 seconds will be counted.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Herrera, MSc, PT

Phone

+56950978252

andrea.herrera.s@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Antonio R Zamuner, PhD

Phone

+56987447384

azamuner@ucm.cl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio R Zamunér, PhD

Organizational Affiliation

Universidad Católica del Maule

Official's Role

Study Director

Facility Information:

Facility Name

Hospital San Juan de Dios de Curicó

City

Curicó

State/Province

Maule

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Herrera, MSc, PT

Phone

+56950978252

andrea.herrera.s@gmail.com

First Name & Middle Initial & Last Name & Degree

Andrea Herrera, MSc, PT

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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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URL

https://doi.org/10.1016/S0009-739X(04)72308-8

Description

Selection of candidates for bariatric surgery

URL

https://doi.org/10.1016/S0716-8640(12)70287-0

Description

Epidemiology of obesity in Chile

URL

https://revistas.upr.edu/index.php/griot/article/view/1775

Description

Historias de vida: una metodología de investigación cualitativa.

URL

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwjo2_X7ivrmAhUcK7kGHcCGDGwQFjAAegQIBRAC&url=https%3A%2F%2Fwww.bmi-journal.com%2Findex.php%2Fbmi%2Farticle%2Fdownload%2F299%2Fpdf&usg=AOvVaw0fG0lZzYS_PxPl5PxiRc8R

Description

Recomendaciones de la SECO para la práctica de la cirugía bariátrica y metabólica

URL

http://www.ub.edu/ice/recerca/pdf/ficha7-cast.pdf

Description

¿Cómo analizar datos cualitativos?.

URL

http://dx.doi.org/10.4067/S0718-40262006000500010

Description

Evaluación mediante score BAROS de los resultados del bypass gástrico en el tratamiento de la obesidad mórbida

URL

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=2ahUKEwjr9NPVi_rmAhVjFLkGHeKaASgQFjADegQIBhAB&url=https%3A%2F%2Fmedicinainterna.org.mx%2Farticle%2Falteraciones-hepaticas-en-el-paciente-con-obesidad-morbida-sometido-a-cirugia-bariatrica%2F&usg=AOvVaw37qDW5Feu0lMuLLudMrwCq

Description

Alteraciones hepáticas en el paciente con obesidad mórbida sometido a cirugía bariátrica

URL

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwi-i_78kPrmAhU_ILkGHXXkBN0QFjAAegQIBhAB&url=http%3A%2F%2Fve.scielo.org%2Fscielo.php%3Fscript%3Dsci_arttext%26pid%3DS1690-31102015000100007&usg=AOvVaw0HEowMfxGoTQKPxKKBDzh1

Description

Tratamiento con cirugía bariátrica en el paciente obeso.

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https://www.minsal.cl/wp-content/uploads/2017/11/ENS-2016-17_PRIMEROS-RESULTADOS.pdf

Description

Encuesta Nacional De Salud 2016-2017, primeros resultados

URL

http://www.who.int/mediacentre/factsheets/fs311/es/

Description

Nota Descriptiva Obesidad y Sobrepeso

URL

http://dx.doi.org/10.1016/j.rchic.2016.05.007

Description

Exercise reduces lean mass loss in obese patients undergoing bariatric surgery

URL

http://dx.doi.org/10.3305/nh.2014.29.1.6937

Description

Evaluation of a structured program of physical exercise in morbidly obese patients awaiting bariatric surgery

URL

http://dx.doi.org/10.4067/S0718-48082012000100006

Description

Quality of life: A theoretical review

URL

http://www.femede.es/documentos/ConsensoCine131.pdf

Description

BODY COMPOSITION ASSESSMENT IN SPORTS MEDICINE. STATEMENT OF SPANISH GROUP OF KINANTHROPOMETRY OF SPANISH FEDERATION OF SPORTS MEDICINE

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Physical Exercise in Postoperative Bariatric Surgery Patients

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