Protocol summary

Study aim
The Effect of Home-based Pulmonary Rehabilitation on Pulmonary Indices and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Design
The research will be a parallel clinical trial study. Random block sampling will be done in two intervention and control groups. Sealedenvelope website was used for randomization.
Settings and conduct
The control group will receive only routine clinic interventions. In the intervention group, the developed home-based rehabilitation care program will be provided in the form of 4 face-to-face sessions of 20 to 30 minutes. Training in verbal and parctical form will be provided in two months. Finally, the questionnaires are completed again, the researcher will be in contact with the patients through the selected messenger group. after the completion of the intervention, the questionnaire measuring the lung function and quality of life of the two control and test groups will be completed.The study will be conducted in Masih Daneshvari Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria • People who Suffer from chronic lung obstruction and at least 3 months have passed since the diagnosis •people who Age from 18 to 70 years Exclusion criteria • people who Suffer from known physical and mental diseases that affect the quality of life • people who do not attend two (or more) follow-up sessions. • people who have participated in another educational program • people who need to be re-hospitalized upon entering the acute phase of the disease. • people who have hearing, visual and touch disorders or who are not able to speak Persian language.
Intervention groups
The research sample will include patients with chronic lung diseases referred to the Asthma and Allergy Clinic of hospitals covered by Shahid Beheshti University in 1402.
Main outcome variables
Quality of Life, Dispenea, Pulmonary Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231126060183N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: retrospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Mohammad Soleimani Arfa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8846 3656
Email address
soleymaniarfa@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-03, 1402/09/12
Expected recruitment end date
2024-02-01, 1402/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Home Pulmonary Rehabilitation on Pulmonary Indices and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Public title
The Effect of Home Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Identified as COPD patient for at least 3 months
Exclusion criteria:
Persons who are suffering from known physical and mental diseases that affect the quality of life, such as dialysis, or other known mental problems, such as depression and schizophrenia, which require medication or a special diet. People who do not attend two (or more) follow-up sessions. People who have participated in another educational program during the research. People who enter the acute phase of the disease and need to be re-hospitalized. People who have hearing, visual and touch disorders or who are not able to speak Persian language.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block random sampling will be done in two intervention and control groups. The sequence of random allocation and the list of blocks will be obtained by the statistical consultant and with the help of R software. The website https://www.sealedenvelope.com is a useful site for generating random sequences for block randomization. This site is designed in such a way that there is no limit on the number of groups for random allocation. The number of people assigned to each group is almost equal. In this method, blocks are formed based on the variables in question. Block randomization works by randomizing participants into blocks, so that an equal number are assigned to each group. Equal numbers of participants are included in the intervention and control groups at consecutive but equal intervals. After each patient and family enter the clinic, according to the block of four (15 blocks of four) prepared in the first stage, each patient will be randomly assigned to group A (intervention) or B (control group). For example, after randomly selecting a block such as ABAB block, patients are randomly placed in the intervention, control, intervention, and control groups, and the next patients are placed in the BBAA block as control, control, intervention, and intervention groups. After creating a random sequence, sampling must be done by hiding the 21 created sequences. In such a way that before assigning an individual, the assigned group is not specific for the samples. This can be done by putting a random sequence inside the envelope and choosing the non-transparent envelope by people. In this method, first a random sequence is created, then based on the size of the research sample, a number of envelopes are prepared and each of the created random sequences is recorded on a card and the cards are placed in the envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened in order and the assigned group of that participant is revealed. becomes Each patient's code will be assigned to his family member. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks.
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 Shahid Beheshti University of Medical Sciences
Street address
13th floor, block A, The central headquarters of the Ministry of Health, Treatment and Medical Educationbetween South Flamak and Zarafshan, Simai Iran St. Quds settlement , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1631693468
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.113

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
Shortness of Breath
Timepoint
Before starting the study and at the end of the study
Method of measurement
Modified Borg Scale

2

Description
Quality of Life
Timepoint
Before starting the study and at the end of the study
Method of measurement
Short-Form Chronic Respiratory Disease Questionnaire

3

Description
Pulmonary Function
Timepoint
Before starting the study and at the end of the study
Method of measurement
6 Minute Walk Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At first, based on random allocation, each patient is entered into the intervention or control group after entering the study. The control group will receive only routine clinic interventions. In the intervention group, the developed home rehabilitation care program will be provided in the form of face-to-face classes in the form of 4 face-to-face sessions of 40 to 60 minutes. Brochures, pamphlets, images and content presentation on the platform will be used for training. Verbal training and practical training will be provided according to the program in two months, and until the questionnaires are completed again, the researcher will be in contact with the patients through the selected messenger group, and weekly summaries of the contents of the educational program will also be provided in the messenger group. and will also answer patients' questions. Again, after the completion of the intervention, the questionnaire measuring the lung function and quality of life of the two control and test groups will be completed.
Category
Rehabilitation

2

Description
Control group: Receive routine care as ordered by doctors
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Fariba Borhani
Street address
Masih Daneshvari Hospital, Darabad, Bahonar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1631693468
Phone
+98 21 7754 3634
Email
info@sbmu.ac.ir
Web page address
https://ehmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Iran-Tehran-Shahid Chamran Highway- Yemen St.-Shahid Arabi St.- 5th Floor Headquarters Building, Shahid Beheshti University of Medical Sciences Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1631693468
Phone
+98 21 8865 5366
Email
sbmuf@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Office of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Borhani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Beheshti University of Medical Sciences, Hashemi Highway & Valiasr St Crossroad, Valiasr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
faribaborhani47@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Borhani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Beheshti University of Medical Sciences, Hashemi Highway & Valiasr St Crossroad, Valiasr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
faribaborhani47@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Borhani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery of Beheshti University of Medical Sciences, Hashemi Highway & Valiasr St Crossroad, Valiasr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
faribaborhani47@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
starting in 2025
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access restrictions are not included for researchers
From where data/document is obtainable
To use the data, an email should be sent to soleymaniarfa@sbmu.ac.ir
What processes are involved for a request to access data/document
As soon as the e-mail is seen, the relevant authorities will be contacted and the information will be available to researchers within a week
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