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Physical ExerciseNCT04235842

Physical Exercise in Postoperative Bariatric Surgery Patients

A study testing Physical Exercise and High-intensity interval training performed at cycle ergometer. in people with Physical Exercise and Bariatric Surgery, run by Universidad Católica del Maule at 1 site in Chile.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Physical Exercise and High-intensity interval training performed at cycle ergometer.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChile
Study dates
2 Dec 2019to 31 Dec 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Hospital San Juan de Dios de Curicó

    Curicó, Maule Region

Other trials in Chile

About this study

Official title: Effects of Physical Exercise in Postoperative Bariatric Surgery Patients

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.

Read the 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.

Being tested
Physical Exercise, High-intensity interval training performed at cycle ergometer.
Medical subject headings
Motor Activity, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ExerciseOther

    Moderate-intensity continuous exercise training performed at cycle ergometer.

  • High-intensity interval training performed at cycle ergometer.Other

    High-intensity interval training performed at cycle ergometer.

Study groups in NCT04235842
Study groupRoleWhat they receive
Control Group (CG)No interventionThe 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)ExperimentalThe 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.
Receives: Other: Physical Exercise
High-intensity interval training exercise group (GHIIT)ExperimentalThe 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.
Receives: Other: High-intensity interval training performed at cycle ergometer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body fat (%)

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

    Measured: 16 weeks

  2. Muscle mass (Kg)

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

    Measured: 16 weeks

  3. Bone mass (Kg)

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

    Measured: 16 weeks

  4. Heart rate variability

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

    Measured: 16 weeks

  5. Six minutes walk test (mts traveled)

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

    Measured: 16 weeks

  6. 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.

    Measured: 16 weeks

  7. 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.

    Measured: 16 weeks

Secondary outcomes (4)
  1. Maximal inspiratory and expiratory pressures (cmH2O)

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

    Measured: 16 weeks

  2. Flowmeter (L/min)

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

    Measured: 16 weeks

  3. Hand grip strength test (Kg)

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

    Measured: 16 weeks

  4. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start2 Dec 2019
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2028 (estimated)

Why it stopped: Due to COVID-19, bariatric surgeries has been suspended and the center where the study was being developed suspended this research.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial, single blinded.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235842
Sponsor's protocol ID
284/2019
Status last verified
Apr 2026
First submitted
16 Jan 2020
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 25929372
  • 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.

    PubMed 22732956
  • 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. Spanish.

    PubMed 16075135
  • 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.

    PubMed 23094966
  • 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.

    PubMed 17658019
  • 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.

    PubMed 25645978
  • 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.

    PubMed 27229736
  • 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.

    PubMed 23848087
  • 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.

    PubMed 26319815
  • 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.

    PubMed 26667705
  • 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.

    PubMed 26545654
  • 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.

    PubMed 25929369
  • 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.

    PubMed 27238789
  • 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.

    PubMed 27019243
  • 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.

    PubMed 22484005

Questions about this trial

What is this clinical trial studying?

A study testing Physical Exercise and High-intensity interval training performed at cycle ergometer. in people with Physical Exercise and Bariatric Surgery, run by Universidad Católica del Maule at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body fat (%) (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235842, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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