Determining the effect of breathing exercises on quality of life and symptoms of shortness of breath and fatigue in patients with Covid-19
Design
A randomized controlled clinical trial with parallel, single-blind, randomized block-block groups on 72 patients
Settings and conduct
This study is a clinical trial that is performed after receiving the code of ethics and the clinical trial code. A list of all eligible individuals in the selected hospitals of the University of Tehran that have the highest admission of patients with Covid-19 will be prepared and randomized.
Blocks are divided into two groups of control and intervention. Blinding will be done blindly by the samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
(1) Patients with Covid-19
(2) Age 18 to 60 years
(3) Having a mobile phone
(4) Have symptoms of shortness of breath or fatigue or every two weeks after discharge from the hospital.
Inclusion criteria include:
(1) Hospitalized in ICU Covid-19
(2) Patients with moderate to severe heart failure (Grade III or IV, New York Heart Association)
(3) COPD or other respiratory and infectious diseases
Intervention groups
During 6 weeks, do daily breathing exercises based on 6 sheets of functional checklist that explains how to do these exercises in the breathing exercise checklist and in the form of bud lip breathing 5 to 10 times each time, diaphragmatic breathing 5 times each time. Up to 15 in each session at home twice a day (morning and evening) for 42 days without interruption is sent to the intervention group after 2 weeks of discharge from the hospital, in addition to providing educational content by calling patients by The researcher also runs for 6 weeks.
Main outcome variables
Shortness of breath, fatigue, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210717051910N1
Registration date:2021-07-30, 1400/05/08
Registration timing:prospective
Last update:2021-07-30, 1400/05/08
Update count:0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
Golrokh Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7784 2192
Email address
abdolahygolii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2021-08-28, 1400/06/06
Actual recruitment end date
2021-09-28, 1400/07/06
Trial completion date
2022-01-21, 1400/11/01
Scientific title
Effect of the breathing exercises on quality of life and symptoms of shortness of breath and fatigue in patients with Covid 19
Public title
Effect of the breathing exercises on quality of life and symptoms of shortness of breath and fatigue in patients with Covid 19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID-19 with respiratory symptoms with radiological manifestations as one or two-way multilobular infiltration in CT scan or chest x-ray whose disease has been confirmed by nasal swap test (RT-PCR SARS-CoV-2)
You have symptoms of shortness of breath or fatigue or every two weeks after discharge from the hospital.
Having a mobile phone
Ages 18 to 60
Exclusion criteria:
Hospitalized in ICU Covid-19
Patients with moderate to severe heart failure (grade III or IV, New York Heart Association)
Having COPD or other respiratory and infectious diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization method using random table of numbers, subjects will be divided into two groups of intervention and control. Randomization units are one of the patients referred to the Corona ward. Randomization tool is also a random table of numbers. The researcher puts numbers on one of the random table numbers and moves to the right and bottom. Records the numbers and assigns them to different study groups whose numbers are already specified.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data collected from both groups will be provided to the data analyzer without specifying which control or esoterry groups were related.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Reserch Ethics Committees of school of nursing and midwifery & rehabilitation-Tehran University of M
Street address
School of Nursing and Midwifery, Nosrat St., Enghelab Square, Tehran University of Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.TUMS.FNM.REC.1400.088
Health conditions studied
1
Description of health condition studied
covid-19b
ICD-10 code
U07.2
ICD-10 code description
covid19, virus not identified
Primary outcomes
1
Description
shortness of breath
Timepoint
Measurement of shortness of breath will be done before the intervention and 6 weeks after the intervention.
Method of measurement
Borg Shortness of breath
2
Description
Fatigue
Timepoint
Fatigue will be measured before the intervention and 6 weeks after the intervention.
Method of measurement
FSS Fatigue Intensity Scale
3
Description
Quality of life
Timepoint
Quality of life will be measured before the intervention and 6 weeks after the intervention.
Method of measurement
Quality of Life Questionnaire SF-36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During 6 weeks, after sending the video and training brochure of breathing exercises as well as checklists that show how to do breathing exercises which are explained in the checklist of breathing exercises and breathing in the form of bud lip 5 to 10 times each time, breathing The diaphragm is 5 to 15 times per session at home twice a day (morning and evening) for 42 days without interruption. It is sent to the intervention group after 2 weeks of discharge from the hospital, in addition to providing educational content to In the intervention group, telephone calls to patients are made by the researcher for 6 weeks. In this way, telephone calls are made twice a week in the first 4 weeks and once a week in the second 2 weeks with the intervention group. The time of the conversation is between 10-12 in the morning and the duration of each conversation is between 5-10 minutes and the content of the conversation will include self-introduction, questions about the patient's general health, and encouraging the patient to follow the recommendations made.
Category
Rehabilitation
2
Description
Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, SF-36 quality of life questionnaire, Borg shortness of breath scale and FSS fatigue severity scale) will be established and completed using a telephone call within 6 weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Golrokh Abdollahi
Street address
Shariati Hospital, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Golrokh Abdollahi
Street address
Imam Khomeini Hospital Complex, Dr. Gharib St., Tehran
City
تهران
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6698 2000
Email
Imamhospital@tums.ac.ir
3
Recruitment center
Name of recruitment center
Amir Alam Hospital Complex
Full name of responsible person
Golrokh Abdolahi
Street address
Enghelab St. - Saadi St. - Amir Alam Hospital Complex
City
تهران
Province
Tehran
Postal code
1744793779
Phone
+98 21 6670 6666
Email
hamiralam@sina.tums.ac.ir
4
Recruitment center
Name of recruitment center
Ziaian Hospital
Full name of responsible person
Golrokh abdollahi
Street address
Qazvin Street, Abuzar Street, Ziaian Hospital
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Email
ziaeian@tums.ac.ir
5
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Golrokh Abdollahi
Street address
Tehran - Railway Square - Beehdari Street - Baharloo Hospital.
City
Tehran
Province
Tehran
Postal code
1339735382
Phone
+98 21 5565 8500
Email
baharloo@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Imam Khomeini Street, Hassan Abad Square, Sina Hospital
City
tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Email
Sahraian1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Golrokh Abdollahi
Position
Postgraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Narmak Street Afshari Kahkvand Alley No. 4 Unit 8
City
Tehran
Province
Tehran
Postal code
1645913539
Phone
+98 21 7784 2192
Email
Abdolahygolii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Golrokh Abdollahi
Position
Postgraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Narmak Street Afshari Alley Avansian No. 4 Unit 8
City
Tehran
Province
Tehran
Postal code
1645913539
Phone
+98 21 7784 2192
Email
Abdolahygolii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Golrokh Abdollahi
Position
Postgraduate Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Narmak Street Afshari Alley Avansian No. 4 Unit 8
City
Tehran
Province
Tehran
Postal code
1645913539
Phone
+98 21 7784 2192
Email
Abdolahygolii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available