Comparison of two methods of routine breathing exercises (pursed lip breathing and diaphragmatic breathing) and the simultaneous use of routine breathing and breathing-stretching exercises on respiratory indicators (oxygen saturation percentage and carbon dioxide pressure), disease severity and exercise capacity in patients with chronic obstructive pulmonary disease
Determining and comparing two methods of routine breathing exercises (pursed lip breathing and diaphragmatic breathing) and the simultaneous use of routine breathing and breathing-stretching exercises on respiratory indicators (oxygen saturation percentage and carbon dioxide pressure), disease severity and exercise capacity in patients with Chronic obstructive pulmonary disease
Design
A clinical trial with a control group, with Parallel groups, one-sided blind, randomized using a table of random numbers, on 32 patients.
Settings and conduct
After approving the project in the ethics and research registration committee, the researcher goes to Imam Reza clinic with a written letter of introduction. Participants will be informed of their presence in the intervention or control group only after the intervention is completed.
Participants/Inclusion and exclusion criteria
Patients with chronic obstructive pulmonary disease/
Including criteria:
Not suffering from a known mental disorder and Absence of acute and chronic diseases affecting the respiratory system.
Excluding criteria:
Occurrence of any complication or exacerbation of the disease (patients whose disease worsens due to causes such as pneumonia, pneumothorax or heart failure or patients who need to be hospitalized) that requires intervention
Intervention groups
The control group will only receive routine breathing exercises (pursed lip and diaphragmatic breathing) and the intervention group, in addition to routine breathing exercises, will receive stretching-breathing exercises for 5 days.
Main outcome variables
The oxygen saturation percentage, the amount of carbon dioxide pressure, the score that people receive from the chronic obstructive pulmonary disease assessment test and the distance that people will travel in 6 minutes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240502061629N1
Registration date:2024-05-08, 1403/02/19
Registration timing:prospective
Last update:2024-05-08, 1403/02/19
Update count:0
Registration date
2024-05-08, 1403/02/19
Registrant information
Name
Fatemeh Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3722 7476
Email address
fateme.zare@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-06, 1403/03/17
Expected recruitment end date
2024-08-07, 1403/05/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of routine breathing exercises (pursed lip breathing and diaphragmatic breathing) and the simultaneous use of routine breathing and breathing-stretching exercises on respiratory indicators (oxygen saturation percentage and carbon dioxide pressure), disease severity and exercise capacity in patients with chronic obstructive pulmonary disease
Public title
the effect of two methods of routine breathing exercises and the simultaneous use of routine breathing and breathing-stretching exercises in patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patient will to participate in the study
Not suffering from a known mental disorder (such as psychotic and depressive disorders that do not cooperate)
Absence of acute and chronic diseases affecting the respiratory system (such as colds and flu)
The ability to talk in Persian
Not suffering from other chronic diseases that interfere with the rehabilitation program (such as skeletal-motor disorders)
patients with stage 2 and 3 of the disease based on Global Initiative for Chronic Obstructive Lung Disease classification
Obtaining lung fellowship approval
Exclusion criteria:
Non-cooperation or unwillingness of the patient to continue participating in the study
Occurrence of any complication or exacerbation of the disease (patients whose disease worsens due to causes such as pneumonia, pneumothorax or heart failure or patients who need to be hospitalized) that requires intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
At first, by using the available sampling method, inpatients with entry criteria are identified and based on the Global Initiative for Chronic Obstructive Lung Disease criteria, grade 2 and 3 chronic obstructive pulmonary disease patients are selected. In the next step, random allocation is done using a table of random numbers and patients are divided into two control groups (breathing exercises) and intervention (simultaneous use of breathing and breathing-stretching exercises).
Blinding (investigator's opinion)
Single blinded
Blinding description
After the necessary information regarding conducting the research is provided to the patients, written informed consent is obtained from the patients; And after random allocation, patients are divided into two control groups (breathing exercises) and intervention (simultaneous use of breathing and breathing-stretching exercises). Participants will be informed of their presence in the intervention or control group only after the intervention is completed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, after Nursing College, Ostad Motahari Street, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.JUMS.REC.1403.008
Health conditions studied
1
Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J43
ICD-10 code description
Emphysema
2
Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Oxygen saturation percentage
Timepoint
before the start of the intervention and 5 days after the start of the intervention
Method of measurement
Pulse oximetr
2
Description
Carbon dioxide pressure
Timepoint
before the start of the intervention and 5 days after the start of the intervention
Method of measurement
Venous blood gases
3
Description
The score that people will get from the chronic obstructive pulmonary disease assessment test
Timepoint
before the start of the intervention and 5 days after the start of the intervention
Method of measurement
chronic obstructive pulmonary disease assessment test
4
Description
The distance that people travel in 6 minutes
Timepoint
before the start of the intervention and 5 days after the start of the intervention
Method of measurement
6-Minute walk test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group receives breathing-stretching exercises, in addition to routine breathing exercises (pursed lip and diaphragmatic breathing). Stretching exercises with breathing control will be performed for the intervention group for 5 days and twice a day (at 10 am and 6 pm). Stretching exercises are done by controlling deep breathing exercises, inhaling through the nose and exhaling through the mouth. The stretching time will be with the inhaling and the tension releasing time will be with the exhaling. On the first day, the patient stretches his hands, wrists and ankles with breathing control while lying on the bed. On the second day, he repeats the exercises of the first session while sitting on the bed and with his legs extended. On the third day, while sitting on the bed, he performs the exercises of the first day along with neck stretching exercises. On the fourth day, the patient gets out of bed and walks and performs arm and shoulder stretching exercises while walking. On the fifth day, the patient tries to walk by raising the knee as much as possible and repeats the stretches of the fourth day.
Category
Rehabilitation
2
Description
Control group: The control group only receives routine breathing exercises (pursed lip and diaphragmatic breathing).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Fatemeh Zare
Street address
Imam Reza Clinic, Peymaniye Hospital, Vali Asr St, Jahrom
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹۷۴۱۴۸
Phone
+98 71 5330 5059
Email
paymaniehbimeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Abdoli
Street address
Deputy of Research and Technology, Jahrom University of Medical Sciences, Ostad Motahari St, Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 6085
Email
pshora2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Zare
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Sadr Shirazi St., Forsat Shirazi Blvd
City
Shiraz
Province
Fars
Postal code
7157664667
Phone
+98 71 3722 7476
Fax
Email
fateme.zare@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Zare
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Sadr Shirazi St., Forsat Shirazi Blvd
City
Shiraz
Province
Fars
Postal code
7157664667
Phone
+98 71 3722 7476
Fax
Email
fateme.zare@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Zare
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Sadr Shirazi St., Forsat Shirazi Blvd
City
Shiraz
Province
Fars
Postal code
7157664667
Phone
+98 71 3722 7476
Fax
Email
fateme.zare@jums.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
Yes - There is 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
.All data is potentially shareable after individuals become incognito.
When the data will become available and for how long
The beginning of the access period is 6 months after the results are published.
To whom data/document is available
The data will be available for students, professors and researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Sending a request through the researcher's email is to access data or documents. The use of data is subject to strict compliance with literary rights and confidentiality.
From where data/document is obtainable
Send a request through the following email to receive data/documents.
fateme.zare@jums.ac.ir
Fatemeh Zareh, nursing master of science student
What processes are involved for a request to access data/document
After the request for data/document via the researcher's email, your email will be answered within 7 days at most.