Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05575089
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-09-23
Brief Title:
Inspiratory Muscle Training and Pulmonary Function in Patients Submitted to Bariatric Surgery
Sponsor:
Universidade Cidade de Sao Paulo
Organization:
Universidade Cidade de Sao Paulo
Study Overview
Official Title:
Pre-operative Inspiratory Muscle Training Effectiveness and Pulmonary Function in Patients Submitted to Bariatric Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity is defined as a body mass index greater than or equal to 30 kg m2 and represents a public health problem that affects the world population It is associated with a higher frequency of cardiovascular metabolic diseases and respiratory morbidities which affect the quality of life of patients Its treatment comprises different strategies however due the conventional treatments surgical treatment has been the most sought after today Objectives To evaluate the effectiveness of preoperative inspiratory muscle training in the evolution of respiratory muscle strength in patients undergoing bariatric surgery Methodology Randomized clinical trial All patients will be assessed in the pre operative period and randomized into 2 groups control group and intervention group The main variables are maximum inspiratory and expiratory muscle strength MIP and MEP peak cough flow PCF and pain Control group will perform proposed respiratory physiotherapy aerobic exercises and use of incentive inspirometry the intervention group will perform proposed physiotherapy aerobic exercises and use of Powerbreathe for inspiratory muscle training Both groups will perform 10 non consecutive face-to-face physiotherapy sessions up 30 days before surgery After the surgical intervention they will be evaluated on the first and 30th postoperative days in relation to the same variables and pulmonary complications Statistical Analysis Sample calculation performed through a previous study 42 patients per group After the intervention they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications Statistical Analysis Sample calculation performed through a previous study 42 patients per group After the intervention they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications Statistical Analysis Sample calculation performed through a previous study 42 patients per group Categorical variables will be summarized in absolute and relative frequencies percentages Information regarding numerical variables will be expressed as means standard deviations or medians and interquartile range depending on the distribution of the variable All variables will be tested in relation to their distribution To analyze the results between groups will be used the mixed linear models and for intragroup analysis two-way ANOVA time and group for the following variables MIP and MEP PCF and pain Expected results Preoperative inspiratory muscle training can maintainimprove respiratory muscle strength until the moment prior to surgery thus better preparing the patient for the condition of surgical stress in addition to decreasing the incidence of pulmonary complications during the hospitalization period and or in the 30 postoperative days
Detailed Description:
This is a controlled and randomized clinical trial that included 106 patients The protocol was approved by the ethics committee 4395114 CAAE 39118720400000064
Inclusion and exclusion criteria The sample consisted of patients for bariatric surgery from an outpatient clinic who were referred to physiotherapy by the medical team to be submitted to the preoperative protocol The inclusion criteria are as follows age over 18 years body body mass index BMI 35 kgm2 indication for elective bariatric surgery by videolaparoscopy The patients would be excluded if they presented hemodynamic instability systolic blood pressure SBP 90mmhg or reduction greater than 40mmhg mean blood pressure MAP 65mmhg tachycardia heart rate 100bpm altered level of consciousness tachypnea respiratory rate RR 18rpm and urine output diuresis 05mlkghr17 Furthermore patients who were not release from their health insurance to undergo the surgery were not included in the study
Randomization Patients will be randomized into two blocks with 42 patients each therefore two treatment groups control and intervention groups Randomization will be performed by a researcher not involved in the recruitment or treatment of the patients through a random draw in Excel software Opaque sealed envelopes were used to ensure blind randomization The envelopes will be kept in a safe place and delivered to the responsible physiotherapist after the initial assessments Before starting the intervention the envelope will be opened by the researcher revealing the group strategy control or intervention
Assessments Preoperative procedures The patients will be evaluated clinically and demographically by the same evaluator and had their data recorded level of physical activity time per week musculoskeletal pain based on the visual analogue scale VAS18 cough peak flow CPF by a peak flow meter19 dyspnea modified Borg scale20 maximum inspiratory pressure MIP and maximum expiratory pressure MEP by a manovacuometer21 respiratory symptoms such as dyspnea and cough and vital signs including systolic blood pressure SBP diastolic blood pressure DBP heart rate HR respiratory rate RR and pulse oxygen saturation SpO2 All the patients will be submitted to a preoperative spirometry in order to exclude previous pulmonary diseases and at the end of the evaluation the patients were randomized into the control group CG or the intervention group IG All patients will be underwent to 10 preoperative physiotherapy sessions and the preoperative evaluations took place during the first and at the end of the 10th session
Preoperative protocol The preoperative exercise protocol will be performed in both groups under a physiotherapists supervision in 10 non-consecutive sessions in an outpatient setting twice a week on average 30 days before the surgical procedure The protocol consist of diaphragmatic breathing and lung re-expansion exercises including fractional inspiration maximum sustained inspiration and pursed lips strategy All respiratory exercises will be performed associated with upper limb exercises and involved three sets of 10 repetitions each Aerobic exercise will be performed on a treadmill or cycle ergometer for 20 minutes with the load and speed set according to the individualized prescription for each patient During the interval between the 10 sessions the patients in both groups will be also instructed to perform standardized exercises daily at home until the moment before surgery Pre- and postoperative instructions will be provided by the same physiotherapist that will be the responsible for the entire perioperative period In addition to guidelines related to the surgical procedure the patients will be instructed to perform respiratory physiotherapy according to preoperative guidance control or intervention group and to wear elastic socks before during and after surgery All patients will be asked to keep a diary about the proposed activities
Control group The patients will be performed all exercises in the preoperative protocol breathing and aerobic exercises in addition to incentive spirometry Respiron in sets of 30 repetitions level 1 40 repetitions level 2 or 50 repetitions level 3 according to their weekly evolution It will be recommended that the patients perform incentive spirometry at home with a frequency of three times a day and an intensity as described above
Intervention group The IMT will be associated to the same exercises offered in the preoperative protocol breathing and aerobic exercises It will be performed with Powerbreathe Medic Plus mechanical model with 60 of the obtained maximum inspiratory pressure in the first preoperative physical therapy evaluation Powerbreathe a muscle training device will be available to the patients and they were instructed to also perform 30 repetitions at home three times a day
In the immediate postoperative period all patients will be kept for 24 hours in the intensive care unit ICU In addition to the guidance received about coughing walking and exercise practices for the lower limbs to prevent deep venous thrombosis all patients will be performed exercises with an incentive spirometer every hour 30 times and will be remained seated between intervals As soon as possible they will walk around the inpatient unit accompanied by the physiotherapist Before hospital discharge 1st PO and on the 30th postoperative day 30th PO the patients will return to outpatient clinic to be evaluated for pain dyspnea MIP MEP CPF and vital signs SBP DBP HR RR and SpO2 Pulmonary complications in the period will be checked
Statistical analysis The sample calculation was obtained from a previous study by Lloréns et al 2015 who evaluated inspiratory muscle strength in clinically severe patients with obesity undergoing bariatric surgery after an IMT program22 A mean MIP difference of 12 2 cmH2O was detected between groups sample power 80 alpha error 5 sample loss 15 42 patients per group The variables will be previously tested in relation to their distribution Mixed linear models will be used to analyze the differences obtained between groups and to assess the intragroup evolution a two-factor analysis of variance ANOVA time and group will be used for the following variables MIP and MEP CPF and pain Statistical Package for the Social Sciences for Windows SPSS version 230 will be used for the analysis and a value of 5 was considered for rejection of the null hypothesis in all tests
Inclusion and exclusion criteria The sample consisted of patients for bariatric surgery from an outpatient clinic who were referred to physiotherapy by the medical team to be submitted to the preoperative protocol The inclusion criteria are as follows age over 18 years body body mass index BMI 35 kgm2 indication for elective bariatric surgery by videolaparoscopy The patients would be excluded if they presented hemodynamic instability systolic blood pressure SBP 90mmhg or reduction greater than 40mmhg mean blood pressure MAP 65mmhg tachycardia heart rate 100bpm altered level of consciousness tachypnea respiratory rate RR 18rpm and urine output diuresis 05mlkghr17 Furthermore patients who were not release from their health insurance to undergo the surgery were not included in the study
Randomization Patients will be randomized into two blocks with 42 patients each therefore two treatment groups control and intervention groups Randomization will be performed by a researcher not involved in the recruitment or treatment of the patients through a random draw in Excel software Opaque sealed envelopes were used to ensure blind randomization The envelopes will be kept in a safe place and delivered to the responsible physiotherapist after the initial assessments Before starting the intervention the envelope will be opened by the researcher revealing the group strategy control or intervention
Assessments Preoperative procedures The patients will be evaluated clinically and demographically by the same evaluator and had their data recorded level of physical activity time per week musculoskeletal pain based on the visual analogue scale VAS18 cough peak flow CPF by a peak flow meter19 dyspnea modified Borg scale20 maximum inspiratory pressure MIP and maximum expiratory pressure MEP by a manovacuometer21 respiratory symptoms such as dyspnea and cough and vital signs including systolic blood pressure SBP diastolic blood pressure DBP heart rate HR respiratory rate RR and pulse oxygen saturation SpO2 All the patients will be submitted to a preoperative spirometry in order to exclude previous pulmonary diseases and at the end of the evaluation the patients were randomized into the control group CG or the intervention group IG All patients will be underwent to 10 preoperative physiotherapy sessions and the preoperative evaluations took place during the first and at the end of the 10th session
Preoperative protocol The preoperative exercise protocol will be performed in both groups under a physiotherapists supervision in 10 non-consecutive sessions in an outpatient setting twice a week on average 30 days before the surgical procedure The protocol consist of diaphragmatic breathing and lung re-expansion exercises including fractional inspiration maximum sustained inspiration and pursed lips strategy All respiratory exercises will be performed associated with upper limb exercises and involved three sets of 10 repetitions each Aerobic exercise will be performed on a treadmill or cycle ergometer for 20 minutes with the load and speed set according to the individualized prescription for each patient During the interval between the 10 sessions the patients in both groups will be also instructed to perform standardized exercises daily at home until the moment before surgery Pre- and postoperative instructions will be provided by the same physiotherapist that will be the responsible for the entire perioperative period In addition to guidelines related to the surgical procedure the patients will be instructed to perform respiratory physiotherapy according to preoperative guidance control or intervention group and to wear elastic socks before during and after surgery All patients will be asked to keep a diary about the proposed activities
Control group The patients will be performed all exercises in the preoperative protocol breathing and aerobic exercises in addition to incentive spirometry Respiron in sets of 30 repetitions level 1 40 repetitions level 2 or 50 repetitions level 3 according to their weekly evolution It will be recommended that the patients perform incentive spirometry at home with a frequency of three times a day and an intensity as described above
Intervention group The IMT will be associated to the same exercises offered in the preoperative protocol breathing and aerobic exercises It will be performed with Powerbreathe Medic Plus mechanical model with 60 of the obtained maximum inspiratory pressure in the first preoperative physical therapy evaluation Powerbreathe a muscle training device will be available to the patients and they were instructed to also perform 30 repetitions at home three times a day
In the immediate postoperative period all patients will be kept for 24 hours in the intensive care unit ICU In addition to the guidance received about coughing walking and exercise practices for the lower limbs to prevent deep venous thrombosis all patients will be performed exercises with an incentive spirometer every hour 30 times and will be remained seated between intervals As soon as possible they will walk around the inpatient unit accompanied by the physiotherapist Before hospital discharge 1st PO and on the 30th postoperative day 30th PO the patients will return to outpatient clinic to be evaluated for pain dyspnea MIP MEP CPF and vital signs SBP DBP HR RR and SpO2 Pulmonary complications in the period will be checked
Statistical analysis The sample calculation was obtained from a previous study by Lloréns et al 2015 who evaluated inspiratory muscle strength in clinically severe patients with obesity undergoing bariatric surgery after an IMT program22 A mean MIP difference of 12 2 cmH2O was detected between groups sample power 80 alpha error 5 sample loss 15 42 patients per group The variables will be previously tested in relation to their distribution Mixed linear models will be used to analyze the differences obtained between groups and to assess the intragroup evolution a two-factor analysis of variance ANOVA time and group will be used for the following variables MIP and MEP CPF and pain Statistical Package for the Social Sciences for Windows SPSS version 230 will be used for the analysis and a value of 5 was considered for rejection of the null hypothesis in all tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None