Investigating the effect of supportive treatments on lung function indicators and fatigue in patients with chronic obstructive pulmonary disease that referred to subspeciality lung clinic
Determining the effect of supportive treatments on lung function indicators and fatigue in chronic obstructive pulmonary disease patients
Design
The clinical trial has 3 intervention groups and a control group, triple blind, randomized, with factorial design, on 60 patients, the second phase.
Settings and conduct
The study was conducted on chronic obstructive pulmonary disease patients by assigning the patients to groups of 15 and performing the rehabilitation intervention of respiratory physiotherapy, breathing exercises and a combination of the two on the patients.
Participants/Inclusion and exclusion criteria
entering :
Willingness of the patient to participate in the study.
Definitive diagnosis of copd by a lung specialist.
Stage 2 to 3 copd.
Confirmation of respected lung specialist the ability to perform breathing exercises and lung physiotherapy.
Not suffering from other chronic and debilitating diseases such as HF.
Exclusion :
Severity of the disease.
Irregular participation .
Death of the patient.
Absence of severe respiratory infections in the last 6 months.
Changing the doctor's order.
Intervention groups
group 1: breathing exercises,diaphragmatic breathing training,lip bud breathing and effective coughing will be done for 20 sessions(3 times a week) for 45 minutes.
group 2:chest percussion, vibration and chest compressions will be used for 20 sessions(3 times a week) for 45 minutes.
group 3, a combination of breathing exercises and chest physiotherapy will be performed for 20 sessions(3 times a week) for 45 minutes.
group, 4 :control group
Main outcome variables
Lung volumes, fatigue intensity
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20230528058322N1
Registration date:2023-07-01, 1402/04/10
Registration timing:prospective
Last update:2023-07-01, 1402/04/10
Update count:0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Sakineh Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4223 0593
Email address
sakine.ghafari777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of supportive treatments on lung function indicators and fatigue in patients with chronic obstructive pulmonary disease that referred to subspeciality lung clinic
Public title
"Investigating the effect of supportive treatments in patients with chronic obstructive pulmonary disease"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the patient to participate in the study
Definitive diagnosis of chronic obstructive pulmonary disease by a lung specialist
Stage 2 to 3 chronic obstructive pulmonary disease
Confirmation of respected lung specialist regarding the ability to perform breathing exercises and lung physiotherapy
Being 40 to 80 years old
Not suffering from other chronic and debilitating diseases such as heart failure
Exclusion criteria:
Severity of the disease
Irregular participation in lung rehabilitation and breathing exercises (not attending more than two sessions)
Non-cooperation in breathing exercises and physiotherapy
Death of the patient
Absence of severe respiratory infections in the last 6 months
Changing the doctor's order
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 available patients with chronic obstructive pulmonary disease, whose disease was confirmed by a lung specialist, were assigned to groups using a table of random numbers. In this way, numbers 1-15 (intervention group 1) group of breathing exercises, numbers 16-30 (intervention group 2) group of respiratory physiotherapy, numbers 31-45 (intervention group 3) combined group of physiotherapy and breathing exercises and numbers 46-60 were selected as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pulmonary rehabilitation and the types of rehabilitation and its effectiveness on lung volumes were explained to the patients participating in the study, who were fully aware of their disease, and the patients participated in the study with full knowledge and consent. They did not know which group they were in and were not in contact with other groups. The outcome evaluator did not know which evaluation group was in which rehabilitation group. The data analyst was also unaware.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Najafabad Islamic Azad University
Street address
university street
City
esfahan
Province
Isfehan
Postal code
5915764575
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1402.050
Health conditions studied
1
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
Lung volumes - patient fatigue
Timepoint
Measurement of long volumes by spirometry before and end of interventions
Method of measurement
spirometry and fatigue Severity Scale(fss)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Breathing exercises: Diaphragmatic breathing, bud lip breathing and effective cough training will be done for 20 sessions (3 times a week) in the clinic for the patient. - The second intervention group: respiratory physiotherapy: chest percussion, vibration and chest compression will be used for 20 sessions (3 sessions per week) for 45 minutes. - The third intervention group: combination of breathing exercises and respiratory physiotherapy for 20 sessions (three times a week)-The control group is taught routine breathing exercises