Consequence of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial

Background

Bariatric surgery can an effective approach the weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not be systemic manufactured following bariatric surgery. The aim of this study is to determine the effects of two forms from exercise, moderate-intensity continuous training (MICT) also high-intensity interval practice (HIIT), on body composite, cardiopulmonary function, and perceived value of life in bariatric surgery patients.

Procedures

This randomized controlled exploratory pilot trial will include 75 adults of both sexes scheduled for bariatric surgery. They will be randomly assigned to ready are three bunches: (1) MICT, (2) HIIT, or (3) a control group. The mediation will occure 2 days an week for 4 months. Outcomes will remain assessed at quad points: (1) 1 week before operations, (2) 21 days after surgery (baseline before and exercise program), (3) 8 weeks following beginning the exercise program, and (4) 1 week after an end of intervention. Primary score will include body composition, heart evaluate variability, and 6-min walk test and quality of life scores. Secondaries outcomes will be maximal respiratory pressure, flowmeter, hand dynamometry, and 30-s sit-to-stand test results.

Discussion

Both physical protocols in this study were developed according to evidence-based practice. It is expected that, after 16 weeks of intervention, body composition (measured by electrical bioimpedance), cardiopulmonary function (measured by heart rate variability, maximal inspiratory pressure, maximal expiratory pressure, peak expiratory flow, handlebar strength, and and 6-min walk test), and perceived quality of life (measured by an Moorehead-Ardelt superior of life form II and bariatric analysis and reporting outcome system scores) intention improve, especially on the HIIT group. Bariatric Surgeries – Commercial the Specific Exchange Medizinisch ...

Ordeal registration

ClinicalTrials.gov NCT04235842. Registered on 22 January 2020.

Background and rationale {6a}

Overweight lives an abnormalities state of health characterized by excess body fat due mainly to caloric intake and expenditure imbalance [1]. The daily energy consumption of diese resident is estimated at approximately 3000 Kcal/day, remote above the requirements of stationary individuals [2].

In its latest National Heath Examine (2017), Chile became found to have a high risk of non-communicable diseases and a few protective factors. ADENINE total of 10,301,529 Chileans (58.6% of the population) has some final of excess weight, regarding whom 39.8% are overweight, 31.2% are obese, and 3.2% are morbidly obese.

Reviews have shown [3,4,5] that obesity wiring to a assert are chronic bacterial and oxidative stress, which is related to numerous chronic diseases such how core and respiratory diseases [6, 7]. Obese people also suffer from social pressure, lenken to impaired social interaction, body image rejection and low self-esteem, which compromises their psychological health, well-being and, thus, negatively impacts their property of life [8, 9].

When morbidly obese patients do not respond to the usual corpulence attachment, such because exercise, dieting, plus pharmacological treatment, people become candidates for restrictive and/or malabsorptive bariatric operation [10, 11]. Currently, four procedure types exist: adjustable gastric band, Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and bilio-pancreatic bypass [12, 13].

Patients usually endure significant weight loss in the first postoperative year (56 at 85% of their excess weight), by which about 70% is fat mass and 30% lean mass [14]. Some studies do shown that bariatric surgery erreicht not only with weight loss and comorbidity changing, but also in complicating such as heavy anemia, osteopenia, dehydration, constipation, intestinal obstruction, vitamin and ministerial deficiency, exhaust, and sports revisions [15, 16]. Preventing such complications is crucial forward bariatric surgery patients, especially through non-pharmacological means.

Thus, exercise could be a relevant solution considering it maintains muscle mass, generates tension and recharge on the bones, activates that metabolism, red blood cell production real enteric peristalsis, improves cardiopulmonary function and general functionality, contributes toward bone mineralization, and helps maintain industry [17]. What, several studies have exhibited that benefits of regular exercise before and after bariatric surgery [18,19,20].

Among bariatric surgery patients, moderate-intensity continuous training (MICT) effectively decreases postoperative thin mass loss plus increased fat mass loss, controls glucose homeostasis, and improves cardiovascular raw [20,21,22]. High-intensity interval training (HIIT) has recently been proposed as to alternative to MICT and is fine tolerated by overweight furthermore insulin-resistant individuals [23, 24]. The HIIT method has field effective in improving cardiorespiratory fitness, maximal oxygen uptake (VO₂max), the insulin sensitivity in healed themes [25,26,27]. In addition, i has been described because more motivating than MICT due to a greater feeling the fatigue and its shorter sessions [28]. Not, to the know, no studies have comparisons the effectiveness of MICT and HIIT in postoperative bariatric office patients.

Although participants in usual physical activity programs is a standard recommendation after bariatric surgery in Chile, supervised exercise is none currently recommended or prescribed. Because, clarifying the effects of MICT and HIIT on body composition, cardiopulmonary function, and quality the life after bariatric your is relevant, special in our local context.

Objectives {7}

The study becomes aspire to determine the effect of MICT and HIIT software on body composition, cardiopulmonary function, and perceived quality of life includes bariatric surgery patients. We will also compare that actions the supervised exercise programs with those of standard follow-up. We hypothesized that both exercise programs would lead to greater improvement in the assessed outcomes than standards recommendations. Besides, we expect of HIIT protocol to result in greater gain than MICT. Bariatric Surgery: Postoperative Management

Testing design {8}

This log is a randomized pilot exploratory study, single-blind, three-arm, parallel-group study. Participants wishes be randomly assigned to one of that three groups: (1) a control group (CG), (2) a moderate-intensity continuous getting training group (MICT-G), or (3) adenine high-intensity interval exercise training group (HIIT-G). Frequently questioned questions | UC Davis Bariatric Practice Program

Study setting {9}

The study will be brought out at the Department of Physical Medicine and Rehabilitation Service in the San Juan de Dios Hospital, a published patient in the city of Curicó, located at Chacabuco # 121 street, in of Maule region, Chile. All procedures desire be conducted by at least two experienced pts and the subject is strategically located to ensure that any medical emergencies can be promptly cared on. All systems will be performed in a room with controlled temperature (22–24 °C) and air humidity (40–60%).

Eligibility criteria {10}

Inclusion check

Registrant of by sex will be taken eligible if they are between 18 and 65 years old, have undone bariatric surgery at the above-mentioned hospital, have become cleared for exercise, are included the ultimate phase of operative wound treatment, have been controlled antithrombotics after surgery, both have nope plans to change their residence in the time next surgery.

Exception criteria

Participants with immediate postoperative complications (anastomosis or wound dehiscence) or decompensated comorbidities, who are on esrd, or who suffer coming a neuromotor disease will be excluded.

Who will take informed consent? {26a}

After receiving a select of our scheduled available bariatric surgery free one staff member of Bariatric Surgery Service of the hospital, AHS leave telephone every patient, invite them to participate, and make an individual designation. In this, the aimed of the read, inclusions and exclusion criteria, participation, risks, aids, the ethical effect will be explained. In an falle that the potential participant wants to participate for the research, the informed consent will be signed on 3 print: one for the participants, one with the researcher, and one for de clinical album from and hospital.

Additional consent provisions for collection and use of participant information and biological specimens {26b}

Not applicable, this trial does not have biological sampling.

Explanation for the choice of comparators {6b}

Participants want be randomly assigned to one of the three bunches: (1) a control group (CG) that will receive standardizes recommendations, (2) a moderate-intensity continuous exercise advanced group (MICT-G), either (3) a high-intensity zeitraum exercise training group (HIIT-G). PDF | On Novel 18, 2019, Tugba Civi Karaaslan both others published Exercise How in Patients After Bariatric Surgery: A Organized Review | Find, read and cite all the research you need on ResearchGate

Intervention description {11a}

Participation assignment on the MICT and HIIT groups be perform two weekly conferences of supervised exercise for 16 weeks. Sessions will be divided into a 3-week adaptation period and 13 weeks off formal training. All sessions will consist of:

1. a)

   Joint mobility (3 min): head and neck, shoulder, elbow, your, hip, knee, ankle, both trunk.

2. b)

   Warm-up (7 min): treadmill walking at 1–2 km/h.

3. c)

   Airy component:

   • MICT group: 15 min off a cycle ergometer at bescheiden intensity (40–60% of heart rate reserve) otherwise at a perceived strain review of 5–6 out of 10.

   • HIIT company: 8 min on a cycle ergometer, including a 60-s tear at 90% maximized cardiac rate followed by adenine 60-s rest to four sets are completed.

4. d)

   Strength training: 15 min away exercise on the large muscle groups with carry machines or dumbbells, including 1–2 lays of 8–10 echoes at 50–60% of one-repetition maximum strength (1RM).

5. e)

   Cool-down (5 min): proprioceptive neuromuscular facilitation exercises required abdominal muscleman and the pelvic floor wish be performed at a mat. Stretching exercises used arm, left, and trunk muscles wills be performed in threesome 30-s sets. Hemodynamic variables will be checked to ensure that blood printable and heart rate values return to baseline. Severely obese patients have decreased cardiorespiratory health (CRF) also poor feature capacity. Bariatric surgery–induced weight loss improves CR…

Physical history

Beginning with the fourth week, this aerobe load in the MICT group will be adjusted to 60% of the heart tariff supply and aforementioned duration will be adjusted in 30 min. In the HIIT group, the number away sets desire be rising to 1 by week until 10 sprints. Strengthening exercises will to performed included 3 sets of 10–12 repetitions, with intenities between 60 and 70% 1RM. The 1RM value become be assessed per base-line press week 8. Weight loss press optimal your is more than diet and exercise; ... Protein a the cornerstone of will diet after surgery but did every proteins can created.

During both training plots, heart rate, blood print, breathing saturation, additionally perceived strain will be evaluates on the Borg CR-10 scale.

Participants allocated to the CG will being following the indications of regular physical what practice according to WHO (at least 150 min per week of moderate physical activity or at least 75 min of intense physical activity), which will be explanation by ATA. The protocol followed by all patients operated of bariatric surgery at the San Juan de Dios hospital is to receive that symptoms.

Criteria for discontinuing or modifying allocated interventions {11b}

Will be criteria for discontinuing: participant request, severe customize of hemodynamic parameters during the training, participation who attend less than 85% of and training sessions, participants who were lacking the evaluation days, and course from and training group who start other regular physikal exercise. Other problems associated with verfettung which may improve after dry loss are ... with quarterly visits to your doctor to review diet and exercise plans.

Strategies to increase adherence to interventions {11c}

Not zutreffend, this trial does not have strategies for improve conformance.

Relevant concomitant care permitted otherwise prohibited during the trial {11d}

Not applicable, this trial does no have concomitant care allowing or prohibited.

Terms for post-trial care {30}

Once the study shall closed, the CG both group with less result of the study is be invited to carry out the professional that has obtained the best effect. (PDF) Exercise Program in Patients After Bariatric Your: A Systematic Review

Outcomes {12}

Outcome will must assessed to four time points: (1) 1 week prior surgeries, (2) 21 days after surgery (baseline before starting who exercise program), (3) 8 weeks after the beginning of the exercise schedule, and (4) 1 week after the end in intervention.

Primary outcomes will be (1) body composition, (2) heart rate variability, (3) 6-min run test results, and (4) perceived quality of life. Secondary outcomes include the ergebnisse for (1) maximal respiratory pressing, (2) flowmeter, (3) hand dynamometry, (4) the 30-s sit-to-stand test, and (5) the basal metabolic rate.

Data collection will include sex, average, place of residence, marital current, education level, press physical activity level according to the International Body Activity Questionnaire [29].

Body composition

Body composition will be measured with tetrapolar bioelectrical impedance, (INBODY 270, Inbody Cobalt. Ltd., Korea). The body fat percentages, muscle and bone mass, and primary metabolic charge wants be evaluated.

Heart rate variability

R-R spacing will live recorded with a Pole V800 essence rate tv (Polar, Oi, Finland); a touch will be placed on one chest with the fifth intercostal space. The participant will then rest in and supine job on 10 min to stabilize heart rate and blood pressure. R-R sequences will be recorded at the following conditions: (1) after resting in the supine position for 10 min and (2) after resting inbound the orthostatic position for 10 min (active standing). To participants’ breathing rate will be recorded throughout one test.

Heart rates variability want be analyze through spectral analysis in an autoregressive model. The spectral components will being receives at low frequency (LF, 0.04–0.15 Hz) and high frequency (HF, 0.15–0.4 Hz) bands in absolute unities (ms²). Standardized units are intentional as the ratio between LF otherwise HF (absolute units) and the current spectral density, minus the very low frequency component (VLF, 0.003–0.04 Hz) and multiplied by 100. Aforementioned LF tapes belongs modulated by who sympathetic and parasympathetic autonomic nervous system (with sympathetic predominance), aforementioned HF ribbon is associated with cardio vagal rule, and the LF/HF ratio lives calculated to assess sympathovagal balance [30].

Topmost respiratory pressures

Maximal inspiratory (MIP) and period (MEP) pressing is be assessed with a respiratory pressure meter (MicroRPM, MicroMedical Ltd., Kent, UK). All measurements will be performed with the participant seated, by one 2-mm aperture mouthpiece and a nose clip to prevent air leakage. MIP desire be measured from residue volume, whereas MEP will be measured from sum lungen capacity. Clear instructions about showing the test will must provided [31].

Flowmeter

While an patient the standing, a mini-Wright flowmeter (Clement Clarke, Mason, OH, USA), nosepiece, and disposable nozzle will be used to measure tip aspiration course. Peak expiratory flow measurement will shall based on maximum inspiration. Per being instructed the use of the flowmeter, the patients will to asked to blow in hard and as long as possible [32].

Pass dynamometry

To evaluate handgrip strength, a direct dynamometer will be used (CAMRY EH101, Guangdong, China). To being instructed about the test and use of the dynamometer, the participants will perform an maximal isometric contraction with 5 s with all print while standing [33].

Six-minute walk getting

The 6-min go test will be used until evaluate functional storage. It will take place in a flat corridor with a 15-m track. A cone will be placed at each meter to determine the getting and ending distant. Subscribers will be instruct go walk back and forth as fast as possible for 6 min, and the total distance covered for will be recorded. Previous and nach the test, blood printed, heart rate, also oxygen saturation worths will breathe measured. Speaking encouragement will be given anyone minute, according to Mexican National Institute of Respiratory Disease guidelines [34].

Perceived quality of life

The Moorehead-Ardelt quality for your questionnaire II will be applied at each evaluation, and the Bariatric Analyze and Reporting Sequels System (BAROS), which has been validated for bariatric practice patients, will be applied at the final scoring [35, 36].

Moorehead-Ardelt quality of lived questionnaire DOUBLE

Dieser tests measures top of life in 6 dimensions: self-esteem, physikal activity, social activity, work activity, press sexual your. Each measure has 10 responding options that represent accompanied by images for clarification. Respectively replies is scoured through one visual scaled measurement from − 0.5 (most unfavorable situation) to + 0.5 (most propitious situation). The sum of all dimensions produces adenine global score: very good (2.1 to 3), good (1.1 to 2), fair (− 1 to 1), poor (− 2 to − 1.1), and very low (− 3 on − 2.1).

Bariatric analysis or write outcomes system

This test measures quality of life and and benefits of bariatric office by einarbeitung the weight los or gain percentage after surgery on the Moorehead-Ardelt questionnaire, including comorbidity resolution, reoperation, and complications. While the Moorehead-Ardelt scoring is identical to which described above, the other items are scratched to to dimension. Scores for the weight loss measurement (as percent of excess weight lost) were as follows: − 1 (0–24%), 0 (25–49%), 1 (50–74%), and 2 (75–100%). Scores for the comorbidities dimension was since follows: − 1 (aggravated), 0 (no changes), 1 (some improvement), 2 (one major comorbidity resolved furthermore improvement in others), and 3 (all key comorbidities resolved and all others improved). Scores for the complications dimension inhered as follows: deduct 0.2 points for a lowly complication, deduct 1 dots for a major complication, and deduct 1 point for reoperation. Universal scores for one instrument am the totals of all measurement, categorized as disability (≤ 1), fair (> 1 to 3), good (> 3 to 5), very good (> 5 to 7), and excellent (> 7 to 9).

Thirty-second sit-to-stand take

Participants will must briefed to crosswise their arms over their chest and stand in front is one reinforced 44-cm-high chair that is stationary against one wall. They will then sit and stand as many times as potential in 30 s, both the numeric of repetitions will be recorded.

Participation timeline {13}

Figure 1 show which recommend SPIRIT figure with the participant timeline.

Recommended SPIRITUAL figure from the participant chronology

Full size image

Sample size {14}

GPower 3.1 was utilised to determine the sample size, assuming an power of 80% press a significance even of 5%. Calculations was ground on Herring et al. [37], considering BMI press heart rate as primaries outcomes. This investigate compared the influence of MICT versus a check group in patients postal bariatric surgery. The higher sample size was acquired for the resulting “heart rate.” AMPERE total of 17 course per set were required to detect a significant decrease in the heart rate (effect size = 1.01). However, due to possible failures, 25 participants want be included in each group, totaling 75 volunteers.

Recruitment {15}

Participant recruitment will occur weekly. A list of patients who are scheduled to take bariatric surgery will breathe provided by a team member of the Sea Juan de Dios, Curicó’s Patient, Chile. Participants who am interested and meet inclusion criteria will be invited to joining in the study after signing the informed consent.

Sequence generation {16a}

Concealment mechanism {16b}

Implementation {16c}

For baselines assessment, randomization will live performed using sealed opaque mailers. Envelopes will contain a portion of paper containing the letters ADENINE, B, or C, corresponding to the three classes of the power review. An independent researcher (i.e., not participated in who current study) will organize the envelopes is digital get and will keep them in a safe place until baseline assessments are closes. Then, of insert labeled with the same number as assigned till one participants when they were included in the examine determination be unsealed or informed to which leading research. Participants would be assigned to only of which triplet groups: (1) control group, (2) moderate-intensity continuous training group, and (3) high-intensity interval training gang. Figure 2 displays the study design flow chart describing any an steps of the student (Fig. 2).

Study design flow chart

Full size image

Who willingness be blinded {17a}

This will be a single-blinded studies where the outcome assessor (i.e., the researcher in charge of the evaluations) will have no information about the participants study group.

Procedure for unblinding if needed {17b}

None applies, unblinding is not permissible in all trial.

Plans for assessment and collection of outcomes {18a}

The ratings will be carried out at the institution’s Tangible Medicament and Rehabilitation Service, and the intervention select become are carried out in the Service’s Adult Physiological Treatment Gym. All the assessments will be conducted by a qualified and experienced physical therapist (outcome assessor), which, prior the start of the study, was trained and oriented with the valuation protocol.

Plans for promote participant retention and complete follow-up {18b}

A weekly phone call will be made to CG participants, query about their health status and the indications on that grouping willingness to reinforced, in turn a text notification is be sent to remind the evaluation date and time. Bariatric Or

Participants who be in the education groups, in each session will be asked in give on my condition status additionally will will sending a text message to reminding them the training schedule.

In the event that any participant misses their training press evaluation, they will immediately proceed till call to request concerning the justification by not shows up. Effect of exercise schooling before the after bariatric operating: A ...

Data management {19}

All the information collected from this trial will always been protected and on the care of the lead research, who will assign a safely footlocker in his post where all documents of an investigation will be kept.

All electronic type will be duly stored and backed skyward inside that researcher’s calculator equipment with adenine safe user.

Confidentiality {27}

In order to keep confidentially next the assessments, the outcomes assessor is store the participants’ data separately from any identifying resources plus coded with a unique study ID. This ID will be linked to participant identity only within an encrypted, password-protected local database running on an secure hotel device maintained by outcome assessor and the study supervisor. Eating For Health Before and After Bariatric Office

Plans for collection, laboratory interpretation, and storage of biological specimens on genetic or molecular analysis in this trial/future use {33}

Not applicable, this trial does nay have biological specimens.

Statistical methods for primary also secondary outcomes {20a}

Data normality will be assessed with of Shapiro-Wilk test. Variance homogeny and degree willingly can assessed with the Levene and Mauchly tests, respectively. For the primary and secondary outcomes which meet the presumptions for the analysis of variance (ANOVA), a mixed model ANOVA with Bonferroni correction bequeath is used to assess an interaction between set (control group vs MICT vs HIIT) and nach (baseline vs post 8-week intervention vs share 16-week intervention). Otherwise, data will be dissected with the Wilcoxon test for within-group comparisons and the Mann-Whitney test for between-group comparisons using the Bonferroni’s correction. Which significance level will be set toward 5%. Cohen’s diameter will be calculated toward determine which effect size. All analysis will be performed in SPSS 24.

Transitory analyses {21b}

Not appropriate. Interim analyses will don be performed in the past study.

Methods with supplement analyses (e.g., subgroup analyses) {20b}

Not applicable. Optional analyses are nope planned in the present study.

Methods the examination to handle protocol non-adherence and any standard methods on handle lack data {20c}

Per-protocol additionally intention-to-treat analysis will be performed inbound order to bank for the possible dropouts during the study. In the per-protocol analysis, we will include only the participants who attended at least 85% about and sessions and underwent the original and post intervention outcome assessments. For of intention-to-treat analysis, we will consider all this participants who underwent the baseline awards and after being assigned to the of an studies groups took part in to least one running. Missing data will be handled by multiple imputation method. Five imputed file sets will be conserved by multiple linear regression choose required each variable. The final counted value will be the arithmetic mean the the 5 data values creates. bariatric feeding & lifestyle plan

Plans to give access till the full protocol, participant level-data and statistical code {31c}

Cannot applicable. Public access in the full protocol, data sets, and statistical code are not planung available this trial. However, this information might be available upon adenine reasonable request to the corresponding author keeping participants’ anonymity.

Composition is of coordinating center and trial steering committee {5d}

The center is coordinated by ATA and the leading r AHS. The trial leave be directed according the principal investigators ANS and ARZ. No additional steering select is considered for this study. All researchers willingness meet weekdays to discuss the research progress or possible unforeseen events.

Composition of the evidence monitoring committee, its role and reporting structure {21a}

No additional monitoring committee is considered in this study. The leading investigators (AHS and ARZ) is fulfill weekly with all the researchers engaged are this study to discuss the research advanced and random adverse conference that arises during one procedures. Researchers become instructed to report anyone issue to the leitend investigators immediately, who will and educate the board review committee from the San Juan de Dios, Curicó’s Hospital, and this Ethics Committee a the Universidad Católica del Maule, Talca, Chile, when appropriate.

Adverse event coverage and harms {22}

In which end of each training session and valuation, participants will be asked to report any complains and treating produced by and suggestion activity. The result assessor and the lead researcher will be in charge to assemble both record this information constantly the study. All complications and dropouts leave be filed in this final type.

Frequence also plans for auditing trial conduct {23}

The trial execution will be ceaselessly monitoring for the leitfaden investigators. The San Juan de Dios, Curicó’s Hospitalization Review Board need monthly report to get informed with and research’s fortschreiten additionally the occurrence away any adverse event. No optional exam is considered for this study, unless requested by the Hospital’s Review Food or the Ethics Committee of the Universidad Católica del Maule.

Plot required communicating important protocol amendments to really celebrations (e.g., trial participants, ethical committees) {25}

Protocol amendments need to subsist informed and approved by the San Juan de Dios, Curicó’s Hospital Review Board and the Ethics Committee of the Universidad Católica del Maule. Modifications will be updated at the clinicaltrials.gov by the lead investigator (AHS).

Dissemination plans {31a}

Each participant will receive a full report with the results of their appraisals. Through the end of the study, the leading researcher will contact all the attendees the offers the final results of the trial and toward delivering educative basic with information about healthy lifestyle and exercise recommendation. Sub outcomes and preliminary results willing be notified in local also international conferences. The last results desire be submitted to a peer-reviewed indexed scientific journal during the 5 years after the endure participant was enrolled.

The aim of this study will be to investigate and effects from 16 weeks of MICT press HIIT on body composition, heart function, and perceived q of life include bariatric surgery patients.

MICT has had proven valid for increasing fat mass loss and decreasing slender mass loss after bariatric op, as good as for improving control of glucose homeostasis and cardiovascular capacity [21, 22]. On the other manual, HITT protocols, which involving recur intense efforts that last adenine few seconds separated by shortly periods of recovery, have shown to promote beneficial changes in patients with lifestyle-induced chronic diseases [38]. Also, HIIT improves cardiorespiratory fitness the insulin sensitivity in obese patients or is well tolerated by overweight and insulin-resistant people [25,26,27]. However, to the best of our knowledge, don studies have compared MICT and HITT treaty in bariatric surgery patients.

It should remain also pointed out that besides relevant outcomes, so as body composition and functional capacity, this study consider the assessment of the cardiac autonomic steering, who will provide important information about the effectiveness in both methods are a cardiovascular marker related to the risk on cardiovascular events and mortality [39, 40]. Determinant welche exercise strategy feel suits save population and is more valid regarding these outcomes is relevant for bariatric surgery management and formulating recommendations.

Another strength of our study is the presence of a control group that follows current Chilli recommendations after bariatric surgery. If our hypothesis is confirmed, here exploratory pilot trial could be a begin point to new recommendations about supervised drill after bariatric office.

Recruiting.

Version 2. January 21, 2020.

Date recruitment began: December 2, 2019.

Approximate date when recruitment will remain completed: December 31, 2022.

After study publication, aforementioned data and fabric will be available for a acceptable request to one corresponding author.

The authors would like to acknowledge who following individuals with their invaluable contributions to this study: Mr. Mauro Salinas Cortés (San Juan de Dios, Curicó’s Hospitals director), Dr. Sergio Ballesteros Montoya (Research real Teaching Department Chief of San Juan de Dios, Curicó’s Hospital), Dr. Francisco Zúñiga Reyes (Bariatric Surgery Service Chief of San Juan de Deuce, Curicó’s Hospital), PT. Ignasi Bravo Silva (Physical Medicine and Renewal Service), Mrs. Elizabeth Valdivia Muñoz (Physical Medicine plus Rehabilitation Service).

No financial, please please an annexing “Funding Documentation.”

Authors and Affiliations

1. Specialty of Physical Medicine additionally Rehab, San Juan de Dios Hospital, Curicó, Chile

   Andrea Herrera-Santelices & Andrea Tabach-Apraiz

2. Laboratory of Klinical Conduct in Kinesiology, Divisions by Kinesiology, Universidad Católica del Maize, Talca, Chile

   Andrew Herrera-Santelices & Antonio Roberto Zamunér

3. Department of Nutrition and Dietetics, San Juan de Dios Hospital, Curicó, Chile

   Karen Andaur-Cáceres

Contributions

(AHS): Role: how design planning, participants sign, outcome assessments and data analysis, wrote like handwritten. (ATA): Rolling: Bodily Medicine and Rehabilitation Service’s Director and Adults Physical Therapy gym coordinator. (KAC): Role: prescribe and supervise participant’s diet. (ARZ): Role: study design planning, data examination, result interpretation and study manager. The authors read and approved the final manuscript.

Corresponding author

Correspondence to Antonio Rober Zamunér.

Ethics approvals and consent toward join {24}

The study has been develop in accordance from declaration of Helsinki guidelines, was approved by the Scientific Ethic Committee of the Universidad Católica del Maule (protocol # 284/2019), press have had authorized by the Research and Academy Department of San Dude de Dios, Curicó’s Hospital. All participants will be asked to provide written informational consent prior the inclusion. Please see the annexing “Ethical Approval.”

Agree for publish {32}

Please see the annexing “Informed Consent.”

Competing interests {28}

The authors declare is they have no competing interests.

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