Protocol summary

Study aim
Investigating the effect of adding the pulmonary rehabilitation to respiratory physiotherapy in patients with COPD exacerbation referring to Masih Daneshvari Hospital
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 82 patients, using a random number table for randomization.
Settings and conduct
The present study is a clinical trial on patients with chronic obstructive pulmonary disease (COPD) exacerbation referred to Masih Daneshvari Hospital in Tehran. In the control group, patients perform breathing exercises along with upper limb stretching. In the intervention group, in addition to the control group exercises, patients perform aerobic exercise on a stationary bike or treadmill. Then, they perform strengthening exercises on the muscles of the upper and lower limbs.
Participants/Inclusion and exclusion criteria
Inclusion criteria included COPD grade 3 and higher (FEV1% predicted"30-49 and ˂30, post bronchodilator FEV1/FVC˂0.7), no comorbidities, no separate medication outside the prescribed line of therapy, patients undergoing oxygen therapy and line of therapy including antibiotics, corticosteroids, bronchodilators (spray) at the same dose, and exclusion criteria included acute cardiac problems, pneumothorax, embolism, musculoskeletal problems, severe distress, and the patient's inability to perform tests.
Intervention groups
In the control group, the patient is initially taught breathing exercises and stretching exercises on the bed by a specialist physiotherapist. In the intervention group, in addition to respiratory physiotherapy, the patient performs an aerobic exercise program on a stationary bike or treadmill, followed by light strengthening exercises.
Main outcome variables
Sit-to-stand test results, 6-minute walk test distance, quality of life, results of the hospital anxiety and depression questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240413061474N3
Registration date: 2025-08-25, 1404/06/03
Registration timing: prospective

Last update: 2025-08-25, 1404/06/03
Update count: 0
Registration date
2025-08-25, 1404/06/03
Registrant information
Name
Abouzar Mojibian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9946
Email address
dr.a.mojibian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding pulmonary rehabilitation to respiratory physiotherapy in patients with COPD exacerbation, referring to Masih Daneshvari Hospital
Public title
Investigating the effect of pulmonary rehabilitation along with respiratory physiotherapy in COPD exacerbation patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
post bronchodilator FEV1/FVC less than 0.7 Predicted FEV1 percentage 30-49 and less than 30(Edited)Restore original Absence of comorbidities Non-receipt of a separate medication outside the prescribed treatment line Patients receiving oxygen therapy Treatment includes antibiotics, corticosteroids, and bronchodilators (spray) at the same dose.
Exclusion criteria:
Acute cardiac problems pneumothorax embolism musculoskeletal problems severe distress patient inability to perform tests
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a simple randomization method is used with the help of a random number table. For this purpose, two groups are named as A and B. We choose one of the rows of the random number table at will, and the numbers in each row will be between 0 and 9. We assign the numbers 0-4 to treatment A and the numbers 5-9 to 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 the School of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Darabad, Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2025-07-29, 1404/05/07
Ethics committee reference number
IR.SBMU.MSP.REC.1404.262

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation

Primary outcomes

1

Description
6-minute walk test distance
Timepoint
Before and after rehabilitation
Method of measurement
6-minute walk test

2

Description
Number of sit-ups in 30 seconds
Timepoint
Before and after rehabilitation
Method of measurement
Sit to stand test

3

Description
Dyspnea
Timepoint
Before and after rehabilitation
Method of measurement
Modified Borg Scale

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and after rehabilitation
Method of measurement
St. George Questionnaire, Chronic Respiratory Disease Questionnaire, Activities of Daily Living Questionnaire

2

Description
Anxiety and depression
Timepoint
Before and after rehabilitation
Method of measurement
Hospital anxiety and depression scale

Intervention groups

1

Description
Intervention group: Initially, the patient is taught breathing exercises and stretching exercises on the bed by a specialist physiotherapist. Breathing exercises include pursed lip breathing with diaphragmatic breathing and deep breathing with upper limb stretching. Then, an aerobic exercise program and strengthening exercises are performed.
Category
Rehabilitation

2

Description
Control group: Patients perform breathing exercises, diaphragmatic breathing, and deep breathing along with upper limb stretching.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Mina Fereydouni
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
zahirireyhane@gmail.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
Mohsen Abedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
mohsenabedi110@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abouzar Mojibian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Masih Daneshvari Hospital
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 1000
Email
dr.a.mojibian@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
reyhanehzahiri@sbmu.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
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
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