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IRCT20220801055596N1 IRCT 2022-10-25 Shahid Beheshti University of Medical Sciences Comparision investigation of The role of threshold loading inspiratory muscle training, with and without biofeedback, on pulmonary function, in in-patient phase of coronary artery bypass graft, before and aftrer surgery Comparison investigation of The role of threshold loading inspiratory muscle training, with and without biofeedback, on pulmonary function, functional capacity and quality of life in in-patient phase of coronary artery bypass graft, before and after surgery 2022-12-22 anticipated 50 Complete https://irct.ir/trial/65067 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we have generally considered 3 intervention groups. And we use stratified and block method for randomization. At first, using the stratified technique and taking into account background factors including age (in two age groups, middle-aged and elderly), gender (male and female) and heart functional class (no symptoms and mild), in general 8 classes in is considered. Then, according to the volume of samples and in order to create a balance in the samples allocated to each of the studied groups, in each floor, we consider blocks of 3 people including 3 patients. And by using the random number table tool, we randomly assign each of the 3 patients to one of the groups. If the numbers were 1, 2, and 3, they would be assigned to group 1, if they were 4, 5, and 6, they would be assigned to group 2, and if they were 7, 8, and 9, they would be assigned to group 3, Blinding description: The 3 treatment methods will be fully explained to the participants in this study, and they will also be informed that they will be assigned to one of these 3 groups, but about the way of randomization and allocation to groups, by The researcher and other health care workers do not find information. Then the intervention and evaluation is done in different groups in separate rooms, and when the samples are in the special section, the distance between the beds and the barrier between them is adjusted in such a way that it is impossible to exchange visual and auditory information, and how There is intervention between different groups for them. Also, the design of the intervention is such that in all three groups, the samples receive the desired intervention along with the usual treatment, which in the placebo group, the intervention is without creating a load and therefore ineffective. N/A pulmonary complications after cardiac surgery, functional capacity after cardiac surgery, inspiratory muscle strength. Intervention 1: The first intervention group: Inspiratory muscle training with threshold loading (TL-IMT) with using an electronic threshold loading device, at a load of 30% of the maximum strength of the inspiratory muscles, twice a day and 30 breathing cycles each time, and Along with respiratory biofeedback, with using the visual feedback in the monitor screen software. Also, patients receive the usual respiratory physiotherapy, including breathing exercises and deep breathing and coughing maneuvers twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. Intervention 2: The second intervention group: inspiratory muscle breathing trainings with threshold loading (TL-IMT) using an electronic threshold loading device, at a load of 30% of the maximum inspiratory muscle strength, twice a day and 30 breathing cycles each time, and without biofeedback , is done. Also, the patients receive the usual respiratory physiotherapy including breathing exercises and deep breathing maneuvers and coughing twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. Intervention 3: Control group: Inspiratory muscle trainings are performed without threshold loading, but using a threshold loading device for inspiratory muscles and as a placebo, in such a way that the amount of load entered on the device is set to zero. Also, patients receive usual respiratory physiotherapy including breathing exercises and deep breathing and coughing maneuvers twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Sedigheh Sadat Naimi
Physiotherapy department, Rehabilitation Sciences Faculty, Shahid Beheshti University of Medical Science, In front of Bo Ali Hospital, Damavand St, Imam Hossein Sq,s,
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 naimi.se@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Sedigheh Sadat Naimi
Physiotherapy department, Rehabilitation Sciences Faculty, Shahid Beheshti University of Medical Sciences, In front of Bo Ali Hospital, Damavand St, Imam Hossein Sq,
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 naimi.se@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults of both sexes with coronary artery disease Patients aged between 50 and 80 years Patients are candidates for CABG surgery Absence of atrial fibrillation and stroke in the past Absence of heart surgery in the past Absence of advanced renal failure (CRF) Absence of chronic obstructive pulmonary disease (COPD) functional cardiac class (NYHA) 1 and 2 50 years 80 years Both Patients who do not understand the technique used Hemodynamic instability during tests or IMT training Emergency surgical intervention Mechanical ventilation time more than 24 hours Need to return to mechanical ventilation The need to return to surgical intervention The presence of symptoms at rest or with minimal effort Mobility disability The patient is blind or visually impaired Sternum infection or instability in the incision site Staying more than 4 days in the ICU Discharge the patient before completing the treatment period The patient's unwillingness to continue the research process The patient's inability to perform tests Presence of any malignancy and chemotherapy of the patient J98.9 Respiratory disorder, unspecified Rehabilitation Rehabilitation Rehabilitation The first intervention group: Inspiratory muscle training with threshold loading (TL-IMT) with using an electronic threshold loading device, at a load of 30% of the maximum strength of the inspiratory muscles, twice a day and 30 breathing cycles each time, and Along with respiratory biofeedback, with using the visual feedback in the monitor screen software. Also, patients receive the usual respiratory physiotherapy, including breathing exercises and deep breathing and coughing maneuvers twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. The second intervention group: inspiratory muscle breathing trainings with threshold loading (TL-IMT) using an electronic threshold loading device, at a load of 30% of the maximum inspiratory muscle strength, twice a day and 30 breathing cycles each time, and without biofeedback , is done. Also, the patients receive the usual respiratory physiotherapy including breathing exercises and deep breathing maneuvers and coughing twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. Control group: Inspiratory muscle trainings are performed without threshold loading, but using a threshold loading device for inspiratory muscles and as a placebo, in such a way that the amount of load entered on the device is set to zero. Also, patients receive usual respiratory physiotherapy including breathing exercises and deep breathing and coughing maneuvers twice a day. All interventions start two days before the operation and continue until the patient is discharged from the hospital. Dynamic inspiratory muscle strength. Timepoint: Before intervention beginning (pre-operation), 12 hours after patient extubation (post-operation), before patient discharge (post- operation). Method of measurement: The score obtained using an electronic device for measuring respiratory muscle strength and The amount of lung volumes and with using the instructions of the Association of Thoracic Surgeons, which is measured by the stress index (S-index) and the unit of centimeters of water (cmH2O). Peak inspiratory flow (PIF). Timepoint: Before intervention beginning (pre-operation), 12 hours after patient extubation (post-operation), before patient discharge (post- operation). Method of measurement: The score obtained using an electronic device for measuring respiratory muscle strength and lung volumes and with using the guidelines of the Association of Thoracic Surgeons, for maximum inspiratory airflow in one second and in unit of liters per second. Patient submaximal functional capacity. Timepoint: Before intervention beginning (pre-operation), before patient discharge from hospital (post- operation). Method of measurement: The distance traveled in meters in the walking test in 6 minutes (6MWT). Quality of life. Timepoint: Before intervention beginning (pre-operation), and two weeks after patient discharge from hospital. Method of measurement: The score obtained using the questionnaire of the quality of life of McNew cardiac patients, which has 27 items. The level of patient comfort during breathing training. Timepoint: Before intervention beginning (pre-operation), 12 hours after patient extubation (post-operation), and before patient discharge (post-operation). Method of measurement: Using a 5-point scale and visualizing the patients level of comfort while performing breathing trainings, from 1, which is without difficulty , to 5, which is the inability to perform the training. Hospital length of stay (HLOS). Timepoint: Before the patient is discharged from the hospital. Method of measurement: The number of days the patient was hospitalized, from the day of surgery to the day of discharge from the hospital. Shahid Beheshti University of Medical Sciences Approved 2022-05-15 Ethics committee of Shahid Beheshti University of Medical Sciences Building No. 2, 5th Floor, Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)