Investigating the effect of pranayama on the respiratory function of recovered patients from covid-19
Design
Before starting the interventions, all independent and dependent variables related to individual characteristics and the main and secondary outputs of the present study will be measured. Then, the participants of the intervention group will perform paranayama exercises on a regular basis, during 12 sessions.
All spirometry measurements in this study will be performed according to standard recommendations. each patient will perform breathing exercises using a standard spirometry to measure forced expiratory flow in the first second , vital capacity , FEV1/FVC ratio should be evaluated.
Settings and conduct
Pranayama breathing is performed 10 rounds of 10 s during 6 weeks and 3 times a week {at homes} and the parameters are checked with spirometry and 6-minute walk methods at Vali E asr Fasa Hospital.
Participants/Inclusion and exclusion criteria
A definite diagnosis of covid-19 and discharge from the hospital
over 18
has not suffered from any other acute illness except for covid-19 in the past 6 months.
The patient does not have Chronic obstructive pulmonary disease or other respiratory diseases
The participant's forced expiratory volume in 1s must be above 70%
discharged from the hospital for a week.
Intervention groups
participants will be selected from among the discharged patients of Covid-19 from Valiasr Hospital.Then, the process of conducting the intervention and reviewing the results will be explained to the qualified people and the participants will enter the study while completing the written informed consent. To measure the desired goals in this study, we need to divide the participants into two control and intervention groups. The subjects will be randomly divided into seven blocks of ten in two groups .
Main outcome variables
Respiratory function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220805055622N1
Registration date:2022-09-23, 1401/07/01
Registration timing:registered_while_recruiting
Last update:2022-09-23, 1401/07/01
Update count:0
Registration date
2022-09-23, 1401/07/01
Registrant information
Name
marzie shahriary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3743 3525
Email address
marzieshahriary1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effects of pranayama on the respiratory function in discharged covid-19 patients
Public title
the effects of pranayama on the respiratory function in discharged covid-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has been discharged from the hospital for a week.
over 18 years of age
In the past 6 months, he has not suffered from any other acute illness except for Covid-19.
The patient does not have Chronic obstructive pulmonary disease or other respiratory diseases.
The participant's forced expiratory volume in 1s must be above 70%. (The recovered patient does not have severe respiratory restriction and is able to participate in the study)
The patient has been discharged from the hospital for a week
Exclusion criteria:
Have underlying cardiovascular diseases including severe ischemia or hemorrhagic stroke
Suffer from neurodegenerative diseases
Get infected with Covid-19 again and show symptoms of the disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We divide people into individual blocks{7 blocks of 10} , which include the following variables.
Age-Sex-Education-Occupation-History of Disease-Body Mass Index {Method of measuring these 6 items is a questionnaire}
experimental group {measurement method is randomization}
6-min walk distance {chronometer}
Forced expiratory volume in 1-inspiratory capacity-inspiratory time to total breathing cycle time-Forced vital capacity-FEV1/FVC {measurement method is Spirometry}
Variable role: independent, dependent, contextual, and confounding
Variable type: continuous quantity, discrete quantity, rank quality, nominal quality
Measurement scale: nominal, ordinal, interval, relative
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of fasa university of medical sciences
Street address
Ebn sina blv.fasa university of medical science
City
Fasa
Province
Fars
Postal code
74616_86688
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.FUMS.REC.1401.049
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of respiratory volume
Timepoint
6 week
Method of measurement
Spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :The intervention group should perform pranayama breathing 3 times a week for 6 weeks and the effect of this exercise will be measured using spirometry and 6 minutes walk .Exercises are provided to people in the form of brochures and educational videos. The executive protocol is as follows: First, sit on all fours on the floor in a comfortable position, so that the back is straight and not hunched over. The position of the eyes can be half open or closed. Breathing begins and all the focus and awareness of the person is directed to his breathing. Correct breathing method: inhale for 4 seconds, hold for 2 seconds and exhale for 4 seconds. According to the ability of each person, the duration of inhaling and exhaling should increase and the duration of inhaling should be longer than inhaling [if possible and without any pressure]. 10-12 times of this breathing. Another exhalation. A deep breath is taken from both nostrils. The right nostril is closed with the thumb and the exhalation comes out from the left nostril. The thumb still remains on the right nostril. Now one breath is done through the left nostril. The breath is held and the little finger is placed on the left nostril and the thumb is removed and exhaled through the right nostril. This breathing period should be done 8 to 10 times according to the person's capacity. This breathing should be done 3 times a week for 6 weeks. In case of dizziness or headache, you should immediately stop the exercise and rest in a state like prostration .After 6 weeks, spirometry and 6 minute walk are performed again and the results are compared with the control group.
Category
Rehabilitation
2
Description
Control group: At the beginning of the study, the control group performs spirometry and 6 minute walk at the same time as the intervention group. In the continuation of the study, this group does not perform any breathing exercises. At the end of the study, after 6 weeks, this group is again performs spirometry and 6 minute walk and the result is measured with the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali e Asr Hospital
Full name of responsible person
Marzie Shahriary
Street address
Ebn Sina Blv
City
Fasa
Province
Fars
Postal code
7158715335
Phone
+98 71 3743 3525
Email
Marzieshahriary1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr Yaser Mansuri
Street address
Ebn Sina Blv
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Email
info@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Marzie Shahriary
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Modares Blv Modares Complex, Block 22, Floor 3, Unit 4