IRCT | 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.

Protocol summary

Study aim: ,Examining the average changes of blood gases, blood parameters, sugar, urea, albumin, bilirubin, creatinine, liver enzymes and blood cells, lactate dehydrogenase enzyme, blood minerals, inflammatory marker CRP, acute phase positive inflammatory proteins D-Dimer , ferritin, percentage of lung involvement with infection, mood state, sleep quality of hospitalized patients with COVID-19 in the intervention groups and comparing it with the control group
Design: Clinical trial with control group, single blind, randomized, phase 3 on 104 patients. Randomization will be done using rand function of Excel software
Settings and conduct: 104 patients with covid-19 hospitalized in the non-special care department of Firouzgar Hospital are randomly divided into 4 groups. All four study groups receive the same drug and non-drug treatments according to the latest published version of the national protocol. The breathing exercise intervention group according to will conduct a study protocol. By assigning a specific code to the participants, blinding is done.
Participants/Inclusion and exclusion criteria: Patients with confirmed covid-19 in non-critical conditions and not hospitalized in the special care department in the age range of 18 to 65 years, as well as the absence of pregnancy and breastfeeding, anti-depressant and anxiety medications, and the absence of underlying diseases
Intervention groups: Group 1: Respiratory muscle training Group 2: N-acetyl cysteine group Group 3: N-acetylcysteine group + respiratory muscles Group 4: control group(by receiving a placebo)
Main outcome variables: Changes in blood gases, blood parameters, sugar, urea, albumin, bilirubin, creatinine, liver enzymes and blood cells, lactate dehydrogenase enzyme, blood minerals, inflammatory marker CRP, acute positive inflammatory phase proteins D-Dimer, ferritin The percentage of lung involvement with infection, mood, sleep quality

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220724055541N1

Registration date: 2022-08-30, 1401/06/08

Registration timing: prospective

Last update: 2022-08-30, 1401/06/08

Update count: 0
Registration date: 2022-08-30, 1401/06/08

Registrant information: Name

shadmehr Mirdar Harijani

Name of organization / entity

University of Mazandaran

Country

Iran (Islamic Republic of)

Phone

+98 11 3530 2254

Email address

sh.mirdar@umz.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-09-02, 1401/06/11
Expected recruitment end date: 2022-11-27, 1401/09/06
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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.

Public title: 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
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

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

Exclusion criteria:

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.
Age: From 18 years old to 65 years old
Gender: Both

Phase

3

Groups that have been masked

Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 104

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Single blinded

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.

Placebo

Used

Assignment

Factorial

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.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committee University of Mazandaran

Street address

Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar

City

Babolsar

Province

Mazandaran

Postal code

4641695447
Approval date: 2022-01-26, 1400/11/06
Ethics committee reference number: IR.UMZ.REC.1401.001

Health conditions studied

1

Description of health condition studied: Corona virus
ICD-10 code: U07.1
ICD-10 code description: COVID-19, virus identified

Primary outcomes

1

Description: The percentage of changes in lung involvement
Timepoint: Before the intervention and 4 weeks after the intervention
Method of measurement: Lung scan

2

Description: 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

Secondary outcomes

1

Description: Hematological profile
Timepoint: Before the intervention and 4 weeks after the intervention
Method of measurement: Biochemical analyses

2

Description: Blood gasesHematological profile
Timepoint: Before the intervention and 4 weeks after the intervention
Method of measurement: Biochemical analyses

3

Description: Inflammatory markers
Timepoint: Before the intervention and 4 weeks after the intervention
Method of measurement: Biochemical analyses

4

Description: 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)

Intervention groups

1

Description: 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.
Category: Treatment - Drugs

2

Description: 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.
Category: Rehabilitation

3

Description: 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.
Category: Treatment - Drugs

4

Description: 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.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Firouzgar Hospital

Full name of responsible person

Mobina Aghajani

Street address

Firouzgar Hospital, Beh Afrin St. Valiasr Square (Aj),Tehran

City

Tehran

Province

Tehran

Postal code

1593748711

Phone

+98 21 8214 1000

Fax

+98 21 8893 7385

Email

firoozgarhospital1@gmail.com

Web page address

https://Firoozgar.iums.ac.ir

1

Sponsor: Name of organization / entity

University of Mazandaran

Full name of responsible person

Dr. Alireza Khesali

Street address

Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar

City

Babolsar

Province

Mazandaran

Postal code

4641695447

Phone

+98 11 3530 2201

Fax

+98 11 3530 2241

Email

physical_education@umz.ac.ir

Web page address

http://pec.umz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: University of Mazandaran
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Mazandaran University

Full name of responsible person

Mobina Aghajani

Position

PhD student in sports physiology

Latest degree

Master

Other areas of specialty/work

Exercise physiology

Street address

Firouzgar Hospital, Beh Afrin St. Valiasr Square (Aj),Tehran

City

Tehran

Province

Tehran

Postal code

1593748711

Phone

+98 21 8214 1000

Fax

+98 21 8893 7385

Email

m.aghajani01@umail.umz.ac.ir

Web page address

https://firoozgar.iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

University of mazandaran

Full name of responsible person

Shadmehr Mirdar Harijani

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

exercise physiology

Street address

Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar

City

Babolsar

Province

Mazandaran

Postal code

4641695447

Phone

+98 11 3530 2201

Fax

+98 11 3530 2201

Email

sh.mirdar@umz.ac.ir

Web page address

http://pec.umz.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Mazandaran University

Full name of responsible person

Shadmehr Mirdar Harijani

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

exercise physiology

Street address

Faculty of Physical Education and Sports Sciences- University Boulevard - Mazandaran University Campus -- Shahid Beheshti Street - Shahid Zulfiqari Boulevard- Babolsar

City

Babolsar

Province

Mazandaran

Postal code

4641695447

Phone

+98 11 3530 2201

Fax

+98 11 3530 2241

Email

sh.mirdar@umz.ac.ir

Web page address

http://pec.umz.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: 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 become available and for how long: The data will be available immediately after the completion of the project. It will probably be published in 1401.
To whom data/document is available: Scholars working in academic and scientific institutions
Under which criteria data/document could be used: For the development of related sciences
From where data/document is obtainable: Refer to Firouzgar Hospital in Tehran by submitting a letter of introduction
What processes are involved for a request to access data/document: Presentation of valid letter from scientific centers
Comments

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.