The effectiveness of respiratory training interventions based on teach back method on the level of the dyspnea, 6-minutes walking test and FEV1% in patients with chronic obstructive pulmonary disease (COPD).
Determining the effectiveness of the program of respiratory training programs based on the teach back method on the level of dyspnea, activity tolerance and FEV1 in chronic obstructive pulmonary patients
Design
A clinical trial with a sample size of 80 and control and test groups were randomly divided into two groups
Settings and conduct
The research population is patients with chronic pulmonary obstruction, which will be selected by simple sampling. The location of the intervention is Kashani and Hajar hospitals in Shahrekord. The number of patients in each group is 40. The intervention group will develop a respiratory training program based on the pattern of rejection and follow up for the test group three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Diagnosis of chronic obstructive pulmonary disease by specialized doctors and recorded in the patient's case
2- Hospitalization in one of the internal departments of Hajar and Kashani hospitals
3. Age under 60 years
4. Lack of cognitive impairment
5- Stability of physical conditions and the ability to attend training sessions
6. Spirometry in the case and FEV1 level greater than 30%
7. No other underlying illness
8. The desire to participate in the training program
9. Minimum reading and writing literacy
Exit criteria:
1. Unwilling to continue the program
2. Exacerbation of the condition for any reason
Intervention groups
Intervention group: The respiratory training will be conducted for the test group and three months follow up will be done for the group. The venue for these sessions will be in the patient's bedside
Main outcome variables
Improvement of patients' respiration, increased activity of patients, improvement of FEV1 in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041449N5
Registration date:2019-05-27, 1398/03/06
Registration timing:retrospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
ali hassanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6720
Email address
alihassanpourdehkordi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of respiratory training interventions based on teach back method on the level of the dyspnea, 6-minutes walking test and FEV1% in patients with chronic obstructive pulmonary disease (COPD).
Public title
Investigation of respiratory exercises in patients with chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Diagnosis of chronic obstructive pulmonary disease by specialized doctors and recorded in the patient's case 2- Hospitalization in one of the internal departments of Hajar and Kashani hospitals 3. Age under 60 years 4. Lack of cognitive impairment 5- Stability of physical conditions and the ability to attend training sessions 6. Spirometry in the case and FEV1 level greater than 30% 7. No other underlying illness 8. The desire to participate in the training program 9. Minimum reading and writing literacy
Exclusion criteria:
1. Failure to continue the program. 2. Exacerbate the condition for any reason
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the fact that the samples are gradually entered into the study, the researcher will use the available method to obtain the samples. Therefore, all patients admitted to the internal departments of Hajar and Kashani Hospitals of Shahr-e-Kord, who have been admitted to study, were selected by the researcher And will enter the study. Since the entry of patients to the study environment is gradual, the researcher will then enter randomly selected patients in the case and control group after selecting the patients with the condition using the Random Allocation Rule method. In this method, according to the sample size, two colors of the card (red and blue ) With the same number and total volume of the sample is placed inside the pot. Then, the qualified individuals entered the study randomly remove one of the cards from the pot and enter the research group according to the definition of the researcher.
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 Shahrkord University Of Medical Sciences
Street address
University Of Medical Sciences, Rahmatie, Shahrkord Town
The beginning of the study, immediately after and three months after the intervention
Method of measurement
Borg Disease Questionnaire
2
Description
6 Minute Walking Test
Timepoint
The beginning of the study, immediately after and three months after the intervention
Method of measurement
Walk within six minutes
3
Description
FEV1(force expiratory volume in second 1)
Timepoint
The beginning of the study, immediately after and three months after the intervention
Method of measurement
Espiratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, training of breathing exercises based on the teachback model with 3-5، 45-minute training sessions In addition to medical treatments and then three months of follow up, will be conducted individually for each of the participants in the group. The venue for these sessions will be in the patient's bedside
Category
Rehabilitation
2
Description
Control group: The control group only receives routine care and treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
ayatollah kashani hospital, nurse ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4826
Email
Kashani@skums.ac.ir
Web page address
http://sapp.ir/kashani_hospital_sh
2
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Hajar hospital, nurse ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3222 0016
Email
hajar@skums.ac.ir
Web page address
https://hajarhp.skums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord..
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Kamal_Solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Ali Hassanpour Dehkordi
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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