Comparing the effects of breathing techniques on diagnostic indicators and changing the quality of life of COPD patients
Design
Each group has 55 people and two groups with 1 to 1 allocation, a total of 110 samples. Allocation of samples in the intervention and control groups is done with random blocks and using online software.
Settings and conduct
Blinding of the patients, the doctor and the evaluator of the results will be implemented. 2 training sessions of routine treatment and training of breathing exercises along with routine treatment individually by a specialist. In addition, this group has the requirements of the control group in addition to its own requirements.
Participants/Inclusion and exclusion criteria
Participants: adult patients with chronic obstructive pulmonary disease (COPD) referring to Bahonar Hospital and the private department of Alborz University professors
Entry requirements for people:
1) Patients diagnosed with moderate and severe COPD (GOLD=2 and GOLD=3)
2) Age over 18 years
After obtaining the informed consent of the subjects, they enter the study and based on random allocation in each of the intervention groups
are under control.
Conditions for exiting people:
1) Patients needing hospitalization
2) Severe obesity (BMI equal to and above 35)
.3) Patients who are not trainable
Intervention groups
1) Intervention group: 2 sessions of regular treatment training and breathing exercise training (including 2 diaphragmatic breathing techniques, compressed lip breathing) along with regular individual treatment by a specialist. Along with the training DVD including these 2 techniques, each person is required to do these exercises at home 3 times a day for 10 minutes each time.
2) Control group: 2 training sessions of usual treatment
Main outcome variables
The effect of respiratory physiotherapy exercises on respiratory indices and quality of life of COPD patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006416N2
Registration date:2023-05-22, 1402/03/01
Registration timing:prospective
Last update:2023-05-22, 1402/03/01
Update count:0
Registration date
2023-05-22, 1402/03/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
02614314400
Email address
kabir.kourosh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of of breathing techniques on pulmonary function and quality of life in adults with chronic obstructive pulmonary diseases (COPD)
Public title
Effect of breathing techniques on COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age over 18 years old
Patients are diagnosed with moderate and severe COPD (gold=2 and gold=3)
Exclusion criteria:
Patients requiring hospitalization
Patients with presence of pulmonary infection
Patients with severe obesity (BMI equal to or above 35)
Patients that need to artificial oxygen
Patients have performed the respiratory physiotherapy before entering into the study
Patients with mild disease (gold=1)
Patients with very severe disease (gold=4)
Patients who are not trainable
Patients with obstructive sleep apnea disorder
Patients with cancer
Patients with neuromuscular weakness
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The daily list of samples will be introduced to the intervention group by the doctor (principal researcher) after checking the conditions for entering the study and obtaining informed consent.
Allocation of samples in the intervention and control groups is done with random blocks.
Random blocks of 4 (28 blocks) and randomization is done using Sealed Envelope online service.
Allocation of samples to two intervention and control groups is done by another person from the plan (random block) and sent to the interventionists by SMS.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding will be used in this study. The patients in both control and intervention groups will be given an educational DVD, and training sessions will be held for both groups, but the difference between the two groups is that in the intervention group, in addition to the usual treatment, breathing exercises will also be taught, but for The control group will only receive the usual treatment. Also, for double-blinding, the recipient of the spirometry test must be unaware of the patients' history.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Alborz University of Medical Sciences
Street address
Secretariat of the Research Ethics Committee of the University, 2nd Floor,Alborz University of Medical Sciences Research and Technology Vice-Chancellor Building, Shahid Safarian St., Golshahr forty-five meters, Karaj
City
Karaj
Province
Alborz
Postal code
3154686695
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.ABZUMS.REC.1402.028
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.0
ICD-10 code description
Chronic obstructive pulmonary disease with acute lower respiratory infection
Primary outcomes
1
Description
quality of life
Timepoint
The beginning of the study, two months after the start of the study
Method of measurement
Quality of life Questionnaire (Clinical COPD Questionnaire)
2
Description
respiratory indicators
Timepoint
The beginning of the study, two months after the start of the study
Method of measurement
Spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with COPD who receive breathing techniques. 2 sessions of regular treatment training and breathing exercise training (including 2 diaphragmatic breathing techniques, compressed lip breathing) along with regular individual treatment by a specialist. Along with the training DVD including these 2 techniques, each person is required to do these exercises at home 3 times a day for 10 minutes each time. In addition, this group has the requirements of the control group in addition to its own requirements. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure that breathing exercises are performed.
Category
Rehabilitation
2
Description
Control group: patients with COPD who received 2 sessions of regular treatment training (including how to use drugs and short-acting sprays and other recommendations) individually by a specialist. Along with an educational DVD containing the same drug recommendations and a series of basic training. Follow-up and evaluation of patients will be done at the beginning of the study and 2 months after the intervention. Patients are examined once at the beginning of the study and again after 2 months (the end of the study). Patients are contacted by phone every week to ensure attendance at the usual treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Karaj Imam Ali Hospital
Full name of responsible person
Shokoofe Zamani
Street address
karaj. shora boulvard, valiasr boulvard, Karaj Imam Ali Hospital
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 912 318 2477
Fax
+98 26 3256 3318
Email
imamali@abzums.ac.ir
Web page address
https://emamali.abzums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Kourosh Kabir
Street address
Dr. Hamed Mohammadi (research assistant), Faculty of Medicine, University of Medical Sciences campus, above Art University, West Buali end, Nebubot Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7359
Email
Kabir.kourosh@yahoo.com
Grant name
Research Council of Alborz university of medical sciences
Grant code / Reference number
5343
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Kourosh Kabir
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
University of Medical Sciences campus, Faculty of Medicine, above Art University, west end of Buali, Nebubot Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
009834287359
Email
kabir.kourosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Kourosh Kabir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Faculty of Medicine, University of Medical Sciences campus, above Art University, west end of Buali, Nebubot Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
009834287359
Email
kabir.kourosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Kourosh Kabir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Faculty of Medicine, University of Medical Sciences campus, above Art University, west end of Buali, Nebubot Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
009834287359
Email
kabir.kourosh@yahoo.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