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IRCT20220724055541N1 IRCT 2022-08-30 University of Mazandaran The effect of respiratory muscle training and N-acetyl cysteine supplementation on hematological profile, blood gases, some inflammatory markers, mood, sleep quality and lung scan The effect of respiratory muscle training and N-acetyl cysteine supplementation on hematological profiles, blood gases, some inflammatory markers, mood, sleep quality, and sleep quality in hospitalized pulmonary patients with corona virus infection. 2022-09-02 anticipated 104 Complete https://irct.ir/trial/65001 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: In addition to the interventions performed in this study, FFQ, sleep, stress and anxiety questionnaires and physical activity will also be used, Randomization description: The method of randomization in this study will be based on the simple randomization method (table of random numbers). By using Random Allocation software and in order to create a random list in Excel software, 104 samples (four identical groups of 26) will be considered in one column, at the end the samples will be sorted from low to high. Also, on a daily basis, patients eligible to enter the study will fill out the FFQ questionnaire, by the registrant based on the list embedded in four groups of 26 people A) control group and B) incentive spirometry group C) N-acetylcysteine ​​group D ) Incentive spirometry group + N-acetylcysteine; Allocation will be random. Enrollees, outcome assessors and the relevant healthcare team will not be aware of the randomisation process are team will not be aware of the randomisation process, Blinding description: Eligible patients will be randomly divided into four specified groups based on the table designed by the researcher. For each patient, a data collection form with a specific code will be determined at the time of entering the study. All patients will enter the study with prior information and informed consent. None of the participants will know about the allocation of groups and The control group will receive a placebo in the same form as the intervention group. The relevant data will be collected by a separate team of collectors and recorded in the designed Data Sheet. Health care providers and the relevant treatment team will also be unaware of the assignment of patients to each of the four groups. Finally, the collected data will be statistically analyzed by the analysis group in four groups A, B, C and D, without the specific label of the groups. 3 Corona virus. Intervention 1: The first intervention group: 1000 mg of N-acetylcysteine by injection twice a day every 12 hours for two weeks as an IV and in the continuation of the intervention two weeks after discharge also at home four effervescent tablets of 500 mg of N-acetylcysteine twice in The day will be available to patients. Intervention 2: For four weeks, patients will use diaphragmatic breathing exercise and incentive spirometer every day according to the researcher's training. According to religion, the patient will lie on his back and a pillow will be placed under his head and a pillow under his knees, and then one hand will be placed on his chest and the other on his stomach. He will breathe deeply through his nose until his chest and stomach are large and full. and then the air will slowly come out of the mouth. This exercise will be done for one minute and then the patient will rest for 30 seconds and later the patient will use the incentive spirometry device. The patient will be taught to use the mouthpiece of the device place his mouth and inhale with maximum power and then hold the air in his mouth as much as possible (at least 5 seconds) and then let the air out slowly and do this 10 times and every one minute He will rest for 30 seconds. Exercise with spirometer will last 5 minutes. Exercises should be done 3 times a day (morning, noon and night). These exercises are taught and supervised by a respiratory muscle physiotherapist. Exercises are monitored through pulse. Oximeter and Borg scale are performed, in addition to that, incentive spirometry and Dia breathing exercise pattern are used Fragami will be available to the participants of the experimental group in the form of pamphlets and films. Intervention 3: The third intervention group: N-acetylcysteine ​​group + respiratory muscles. For four weeks, patients will use diaphragmatic breathing exercise and incentive spirometer every day according to the researcher's training. According to religion, the patient will lie on his back and a pillow will be placed under his head and a pillow under his knees, and then one hand will be placed on his chest and the other on his stomach. He will breathe deeply through his nose until his chest and stomach are large and full. and then the air will slowly come out of the mouth. This exercise will be done for one minute and then the patient will rest for 30 seconds and later the patient will use the incentive spirometry device. The patient will be taught to use the mouthpiece of the device place his mouth and inhale with maximum power and then hold the air in his mouth as much as possible (at least 5 seconds) and then let the air out slowly and do this 10 times and every one minute He will rest for 30 seconds. Exercise with spirometer will last 5 minutes. Exercises should be done 3 times a day (morning, noon and night). These exercises are taught and supervised by a respiratory muscle physiotherapist. Exercises are monitored through pulse. Oximeter and Borg scale are performed, in addition to that, incentive spirometry and Dia breathing exercise pattern are used Fragami in the form of pamphlets and films will be provided to the participants of the experimental group, and at the same time, these people will receive 1000 mg of N-acetylcysteine ​​injected twice a day every 12 hours for two weeks as an IV and in the continuation of the intervention two weeks after discharge. At home, four 500 mg N-acetylcysteine ​​effervescent tablets will be provided to patients four times a day. Intervention 4: Control group: The patients of this group did not receive any additional intervention and received the same drug and non-drug treatments as the intervention group, based on the opinion of the relevant treatment team according to the latest published version of the national protocol. This group received four 500 mg starch capsules daily. They will take it as a placebo for eight weeks. The placebo will be prepared by Karen Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Tehran, all inclusive data (IPD), study protocol, statistical analysis map, informed consent form, clinical study report and data dictionary will be published after the completion of the study. The identity of the participants will not be published When: The data will be available immediately after the completion of the project. It will probably be published in 1401. To whom: Scholars working in academic and scientific institutions Conditions: For the development of related sciences Where to obtain: Refer to Firouzgar Hospital in Tehran by submitting a letter of introduction How to obtain: Presentation of valid letter from scientific centers Comments:
public Mobina Aghajani
Firouzgar Hospital, Beh Afrin St. Valiasr Square (Aj),Tehran
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1000 m.aghajani01@umail.umz.ac.ir Mazandaran University scientific Shadmehr Mirdar Harijani
Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar
Babolsar Iran (Islamic Republic of) 4641695447 +98 11 3530 2201 sh.mirdar@umz.ac.ir University of mazandaran Iran (Islamic Republic of) Willingness to cooperate with the plan 18 to 65 years old Patients with COVID-19 whose disease has been fully confirmed through complete medical examination, pathology and laboratory information Patients with COVID-19 in non-critical conditions and not hospitalized in the intensive care unit 18 years 65 years Both smoking alcohol consumption Pregnancy and breastfeeding People who, in addition to COVID-19, have other diseases, such as severe kidney, liver, thyroid and parathyroid, glandular, gastrointestinal diseases, and heart and cancer patients. U07.1 COVID-19, virus identified Treatment - Drugs Rehabilitation Treatment - Drugs Placebo The first intervention group: 1000 mg of N-acetylcysteine by injection twice a day every 12 hours for two weeks as an IV and in the continuation of the intervention two weeks after discharge also at home four effervescent tablets of 500 mg of N-acetylcysteine twice in The day will be available to patients. For four weeks, patients will use diaphragmatic breathing exercise and incentive spirometer every day according to the researcher's training. According to religion, the patient will lie on his back and a pillow will be placed under his head and a pillow under his knees, and then one hand will be placed on his chest and the other on his stomach. He will breathe deeply through his nose until his chest and stomach are large and full. and then the air will slowly come out of the mouth. This exercise will be done for one minute and then the patient will rest for 30 seconds and later the patient will use the incentive spirometry device. The patient will be taught to use the mouthpiece of the device place his mouth and inhale with maximum power and then hold the air in his mouth as much as possible (at least 5 seconds) and then let the air out slowly and do this 10 times and every one minute He will rest for 30 seconds. Exercise with spirometer will last 5 minutes. Exercises should be done 3 times a day (morning, noon and night). These exercises are taught and supervised by a respiratory muscle physiotherapist. Exercises are monitored through pulse. Oximeter and Borg scale are performed, in addition to that, incentive spirometry and Dia breathing exercise pattern are used Fragami will be available to the participants of the experimental group in the form of pamphlets and films. The third intervention group: N-acetylcysteine ​​group + respiratory muscles. For four weeks, patients will use diaphragmatic breathing exercise and incentive spirometer every day according to the researcher's training. According to religion, the patient will lie on his back and a pillow will be placed under his head and a pillow under his knees, and then one hand will be placed on his chest and the other on his stomach. He will breathe deeply through his nose until his chest and stomach are large and full. and then the air will slowly come out of the mouth. This exercise will be done for one minute and then the patient will rest for 30 seconds and later the patient will use the incentive spirometry device. The patient will be taught to use the mouthpiece of the device place his mouth and inhale with maximum power and then hold the air in his mouth as much as possible (at least 5 seconds) and then let the air out slowly and do this 10 times and every one minute He will rest for 30 seconds. Exercise with spirometer will last 5 minutes. Exercises should be done 3 times a day (morning, noon and night). These exercises are taught and supervised by a respiratory muscle physiotherapist. Exercises are monitored through pulse. Oximeter and Borg scale are performed, in addition to that, incentive spirometry and Dia breathing exercise pattern are used Fragami in the form of pamphlets and films will be provided to the participants of the experimental group, and at the same time, these people will receive 1000 mg of N-acetylcysteine ​​injected twice a day every 12 hours for two weeks as an IV and in the continuation of the intervention two weeks after discharge. At home, four 500 mg N-acetylcysteine ​​effervescent tablets will be provided to patients four times a day. Control group: The patients of this group did not receive any additional intervention and received the same drug and non-drug treatments as the intervention group, based on the opinion of the relevant treatment team according to the latest published version of the national protocol. This group received four 500 mg starch capsules daily. They will take it as a placebo for eight weeks. The placebo will be prepared by Karen Pharmaceutical Company. The percentage of changes in lung involvement. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Lung scan. State of mind. Timepoint: Before the intervention, 4 weeks after the intervention and 2 months after the intervention. Method of measurement: DASS 21 question questionnaire. Hematological profile. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Biochemical analyses. Blood gasesHematological profile. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Biochemical analyses. Inflammatory markers. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Biochemical analyses. Sleep quality. Timepoint: Before the intervention, 4 weeks after the intervention and 2 months after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). University of Mazandaran Approved 2022-01-26 Research Ethics Committee University of Mazandaran Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar Babolsar Mazandaran Iran (Islamic Republic of)