Physical Exercise in Postoperative Bariatric Surgery Patients

Morbid Obesity Clinical Trial

Official title:

Effects of Physical Exercise in Postoperative Bariatric Surgery Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04235842
• Other study ID #: 284/2019
• Status: Suspended
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Universidad Católica del Maule
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Suspended
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Morbid Obesity
• Obesity, Morbid
• Physical Exercise

Intervention

Other:
• Physical Exercise
Moderate-intensity continuous exercise training performed at cycle ergometer.
• High-intensity interval training performed at cycle ergometer.
High-intensity interval training performed at cycle ergometer.

Locations

Country	Name	City	State
Chile	Hospital San Juan de Dios de Curicó	Curicó	Maule

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica del Maule

Country where clinical trial is conducted

Chile, 

References & Publications (28)

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. — View Citation

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. — View Citation

Brzozowska MM, Sainsbury A, Eisman JA, Baldock PA, Center JR. Bariatric surgery, bone loss, obesity and possible mechanisms. Obes Rev. 2013 Jan;14(1):52-67. doi: 10.1111/j.1467-789X.2012.01050.x. Epub 2012 Oct 25. — View Citation

Carrasco F, Klaassen J, Papapietro K, Reyes E, Rodriguez L, Csendes A, Guzman S, Hernandez F, Pizarro T, Sepulveda A. [A proposal of guidelines for surgical management of obesity]. Rev Med Chil. 2005 Jun;133(6):699-706. doi: 10.4067/s0034-98872005000600013. Epub 2005 Jul 22. Erratum In: Rev Med Chil. 2005 Aug;133(8):986. Spanish. — View Citation

Carrasco F, Papapietro K, Csendes A, Salazar G, Echenique C, Lisboa C, Diaz E, Rojas J. Changes in resting energy expenditure and body composition after weight loss following Roux-en-Y gastric bypass. Obes Surg. 2007 May;17(5):608-16. doi: 10.1007/s11695-007-9117-z. Erratum In: Obes Surg. 2007 Jul;17(7):996. — View Citation

Cocks M, Shaw CS, Shepherd SO, Fisher JP, Ranasinghe A, Barker TA, Wagenmakers AJ. Sprint interval and moderate-intensity continuous training have equal benefits on aerobic capacity, insulin sensitivity, muscle capillarisation and endothelial eNOS/NAD(P)Hoxidase protein ratio in obese men. J Physiol. 2016 Apr 15;594(8):2307-21. doi: 10.1113/jphysiol.2014.285254. Epub 2015 Feb 24. — View Citation

Coleman KJ, Caparosa SL, Nichols JF, Fujioka K, Koebnick C, McCloskey KN, Xiang AH, Ngor EW, Levy SS. Understanding the Capacity for Exercise in Post-Bariatric Patients. Obes Surg. 2017 Jan;27(1):51-58. doi: 10.1007/s11695-016-2240-y. — View Citation

De Tursi Rispoli L, Vazquez Tarragon A, Vazquez Prado A, Saez Tormo G, Mahmoud Ismail A, Gumbau Puchol V. [Oxidative stress; a comparative study between normal and morbid obesity group population]. Nutr Hosp. 2013 May-Jun;28(3):671-5. doi: 10.3305/nh.2013.28.3.6355. Spanish. — View Citation

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. — View Citation

Delgado Floody P, Caamano Navarrete F, Osorio Poblete A, Jerez Mayorga D. Variaciones en el estado nutricional, presion arterial y capacidad cardiorrespiratoria de obesos candidatos a cirugia bariatrica: beneficios del ejercicio fisico con apoyo multidisciplinar. Nutr Hosp. 2016 Feb 16;33(1):16. doi: 10.20960/nh.v33i1.16. Spanish. — View Citation

Delgado Floody P, Caamano Navarrete F, Ovalle Elgueta H, Concha Diaz M, Jerez Mayorga D, Osorio Poblete A. Efectos de un programa de ejercicio fisico estructurado sobre los niveles de condicion fisica y el estado nutricional de obesos morbidos y obesos con comorbilidades. Nutr Hosp. 2016 Mar 25;33(2):107. doi: 10.20960/nh.107. Spanish. — View Citation

Delgado Floody P, Cofre Lizama A, Alarcon Hormazabal M, Osorio Poblete A, Caamano Navarrete F, Jerez Mayorga D. [EVALUATION OF A COMPREHENSIVE PROGRAM OF FOUR MONTHS OF DURATION ON THE PREOPERATIVE CONDITIONS OF OBESE PATIENTS CANDIDATES FOR BARIATRIC SURGERY]. Nutr Hosp. 2015 Sep 1;32(3):1022-7. doi: 10.3305/nh.2015.32.3.9350. Spanish. — View Citation

Delgado Floody P, Jerez Mayorga D, Caamano Navarrete F, Concha Diaz M, Ovalle Elgueta H, Osorio Poblete A. [EFFECTIVENESS OF COMPREHENSIVE TREATMENT ON THE PREOPERATIVE CONDITIONS OF OBESE WOMEN CANDIDATES FOR BARIATRIC SURGERY]. Nutr Hosp. 2015 Dec 1;32(6):2570-5. doi: 10.3305/nh.2015.32.6.9761. Spanish. — View Citation

Delgado Floody P, Jerez Mayorga D, Caamano Navarrete F, Osorio Poblete A, Thuillier Lepeley N, Alarcon Hormazabal M. [TWELVE WEEKS OF PHYSICAL EXERCISE INTERVAL WITH SURCHARGE IMPROVES THE ANTHROPOMETRIC VARIABLES OF OBESE MORBID AND OBESE WITH COMORBIDITIES CANDIDATES TO BARIATRIC SURGERY]. Nutr Hosp. 2015 Nov 1;32(5):2007-11. doi: 10.3305/nh.2015.32.5.9610. Spanish. — View Citation

Folope V, Chapelle C, Grigioni S, Coeffier M, Dechelotte P. Impact of eating disorders and psychological distress on the quality of life of obese people. Nutrition. 2012 Jul;28(7-8):e7-e13. doi: 10.1016/j.nut.2011.12.005. Epub 2012 Apr 7. — View Citation

Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30. — View Citation

Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000. — View Citation

Herring LY, Stevinson C, Carter P, Biddle SJH, Bowrey D, Sutton C, Davies MJ. The effects of supervised exercise training 12-24 months after bariatric surgery on physical function and body composition: a randomised controlled trial. Int J Obes (Lond). 2017 Jun;41(6):909-916. doi: 10.1038/ijo.2017.60. Epub 2017 Mar 6. — View Citation

Hewitt S, Sovik TT, Aasheim ET, Kristinsson J, Jahnsen J, Birketvedt GS, Bohmer T, Eriksen EF, Mala T. Secondary hyperparathyroidism, vitamin D sufficiency, and serum calcium 5 years after gastric bypass and duodenal switch. Obes Surg. 2013 Mar;23(3):384-90. doi: 10.1007/s11695-012-0772-3. — View Citation

Jung ME, Bourne JE, Beauchamp MR, Robinson E, Little JP. High-intensity interval training as an efficacious alternative to moderate-intensity continuous training for adults with prediabetes. J Diabetes Res. 2015;2015:191595. doi: 10.1155/2015/191595. Epub 2015 Mar 30. — View Citation

Kessler HS, Sisson SB, Short KR. The potential for high-intensity interval training to reduce cardiometabolic disease risk. Sports Med. 2012 Jun 1;42(6):489-509. doi: 10.2165/11630910-000000000-00000. — View Citation

Lund MT, Hansen M, Wimmelmann CL, Taudorf LR, Helge JW, Mortensen EL, Dela F. Increased post-operative cardiopulmonary fitness in gastric bypass patients is explained by weight loss. Scand J Med Sci Sports. 2016 Dec;26(12):1428-1434. doi: 10.1111/sms.12593. Epub 2015 Dec 4. — View Citation

Matsuo T, Saotome K, Seino S, Shimojo N, Matsushita A, Iemitsu M, Ohshima H, Tanaka K, Mukai C. Effects of a low-volume aerobic-type interval exercise on VO2max and cardiac mass. Med Sci Sports Exerc. 2014 Jan;46(1):42-50. doi: 10.1249/MSS.0b013e3182a38da8. — View Citation

Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237. — View Citation

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. — View Citation

Sim AY, Wallman KE, Fairchild TJ, Guelfi KJ. High-intensity intermittent exercise attenuates ad-libitum energy intake. Int J Obes (Lond). 2014 Mar;38(3):417-22. doi: 10.1038/ijo.2013.102. Epub 2013 Jun 4. — View Citation

Tschentscher M, Eichinger J, Egger A, Droese S, Schonfelder M, Niebauer J. High-intensity interval training is not superior to other forms of endurance training during cardiac rehabilitation. Eur J Prev Cardiol. 2016 Jan;23(1):14-20. doi: 10.1177/2047487314560100. Epub 2014 Nov 17. — View Citation

Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Heart rate variability	To determine the effects of HIIT and MCIT on cardiac autonomic control in supine and orthostatic positions.	16 weeks
Primary	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
Primary	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
Primary	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.	16 weeks
Secondary	Maximal inspiratory and expiratory pressures (cmH2O)	To determine the effects of HIIT and MCIT on the maximal inspiratory and expiratory pressures.	16 weeks
Secondary	Flowmeter (L/min)	To determine the effects of HIIT and MCIT on the peak expiratory flow.	16 weeks
Secondary	Hand grip strength test (Kg)	To determine the effects of HIIT and MCIT on the maximum prehensile force will be measured.	16 weeks
Secondary	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

External Links

•   ¿Cómo analizar datos cualitativos?.
•   Alteraciones hepáticas en el paciente con obesidad mórbida sometido a cirugía bariátrica
•   BODY COMPOSITION ASSESSMENT IN SPORTS MEDICINE. STATEMENT OF SPANISH GROUP OF KINANTHROPOMETRY OF SPANISH FEDERATION OF SPORTS MEDICINE
•   Encuesta Nacional De Salud 2016-2017, primeros resultados
•   Epidemiology of obesity in Chile
•   Evaluación mediante score BAROS de los resultados del bypass gástrico en el tratamiento de la obesidad mórbida
•   Evaluation of a structured program of physical exercise in morbidly obese patients awaiting bariatric surgery
•   Exercise reduces lean mass loss in obese patients undergoing bariatric surgery
•   Historias de vida: una metodología de investigación cualitativa.
•   Nota Descriptiva Obesidad y Sobrepeso
•   Quality of life: A theoretical review
•   Recomendaciones de la SECO para la práctica de la cirugía bariátrica y metabólica
•   Selection of candidates for bariatric surgery
•   Tratamiento con cirugía bariátrica en el paciente obeso.