Protocol summary

Study aim
Studying the effect of telerehabilitation on physical and respiratory indices in patients with chronic respiratory disease
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 80 patients, using a random number table for randomization.
Settings and conduct
The present study is a clinical trial on patients with COPD referred to Masih Daneshvari Hospital in Tehran. In the control group, patients receive respiratory rehabilitation upon discharge from the hospital. In the intervention group, patients undergo pulmonary telerehabilitation upon discharge in addition to the respiratory rehabilitation program. This study is single-blinded, and the collected information is provided to the person evaluating the outcomes by removing the names and grouping of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria included the patient's willingness to participate in the research project, COPD diagnosis based on a specialist physician's diagnosis, ability to perform rehabilitation during the days of hospitalization, and exclusion criteria included active cancer, advanced heart failure, advanced renal dysfunction, diabetes or uncontrolled blood pressure, inability of the patient to use a smartphone, and any disorder prohibiting rehabilitation exercises (musculoskeletal, neurological, etc.).
Intervention groups
In the intervention group, COPD patients who have undergone specialized treatment and rehabilitation at the center receive a username and password for the rehabilitation site upon discharge from the hospital and undergo telerehabilitation. In the control group, COPD patients receive only the recommended respiratory rehabilitation program.
Main outcome variables
Functional capacity, number of sit-stands, results of chronic obstructive pulmonary disease assessment questionnaires, and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210813052172N3
Registration date: 2025-10-28, 1404/08/06
Registration timing: prospective

Last update: 2025-10-28, 1404/08/06
Update count: 0
Registration date
2025-10-28, 1404/08/06
Registrant information
Name
Masoumeh ZoghAli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3662 4225
Email address
masoumezoghali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of telerehabilitation on physical and respiratory indicators of patients with chronic respiratory diseases
Public title
Investigating the effect of telerehabilitation on patients with chronic respiratory diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's willingness to participate in the research project COPD diagnosis based on a specialist doctor's diagnosis Ability to perform rehabilitation during hospital stay
Exclusion criteria:
Active cancer Advanced heart failure Advanced renal dysfunction Diabetes or uncontrolled blood pressure The patient's inability to use a smartphone Any disorder that prevents rehabilitation exercises (musculoskeletal, neurological, etc.)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit, randomization tool: Random number table. For randomization, the Simple Randomization method is used using a random number table. For this purpose, two groups (A, B) are considered. We choose one of the rows of the random number table at will and we know that the numbers in each row will be between 0 and 9. Then we assign the numbers 0-4 to treatment A and the numbers 5-9 to treatment B. Suppose the numbers for the first row are as follows: 0, 5, 2, 7, 8, 4. Therefore, the number 0 is assigned to treatment A, the number 5 to treatment B, the number 2 to treatment A, .... Therefore, the first person receives treatment A, the second person receives treatment B ....
Blinding (investigator's opinion)
Single blinded
Blinding description
The clinical outcome assessor will not have access to patient grouping and will remain blinded throughout the study. Patients and therapists will not be blinded
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
Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2025-10-08, 1404/07/16
Ethics committee reference number
IR.SBMU.MSP.REC.1404.363

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Functional capacity
Timepoint
Before and after rehabilitation
Method of measurement
Based on distance of six minute walk test

Secondary outcomes

1

Description
Total score of the Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
Timepoint
Before and after rehabilitation
Method of measurement
Chronic obstructive pulmonary disease assessment test (CAT)

2

Description
Quality of life
Timepoint
Before and after rehabilitation
Method of measurement
Chronic respiratory disease questionnaire (CRDQ)

3

Description
Quality of life
Timepoint
Before and after rehabilitation
Method of measurement
London chest activity of daily living (LCADL)

4

Description
Quality of life
Timepoint
Before and after rehabilitation
Method of measurement
Total score of St. George's questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group, patients with COPD who have undergone specialized treatment and rehabilitation at the center will receive a username and password for the Masih Daneshvari Hospital rehabilitation site upon discharge from the hospital and will implement the pulmonary telerehabilitation program at home. After eight weeks, the patient will return to the hospital and be evaluated on an outpatient basis.
Category
Rehabilitation

2

Description
Control group: In the control group, patients with COPD who have undergone specialized treatment and rehabilitation at the center are discharged after receiving the recommended respiratory rehabilitation program including pursed lip breathing, diaphragmatic breathing, and sputum evacuation techniques. After eight weeks from discharge, patients are called back to the Pulmonary Rehabilitation Clinic of Masih Daneshvari Hospital.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Zahra Valizadeh
Street address
Masih danedvari hospital, darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
zahravalizadeh1374@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yemen St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1920
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Maryam Sadat Mirenayat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
MirenayaT_M@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Zoghali
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
masoumezoghali@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biotechnology
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
zahirireyhane@gmail.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
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
No - There is not a plan to make this available
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