Protocol summary

Study aim
The effect of respiratory rehabilitation before and after pulmonary endarterectomy (PEA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH)
Design
A clinical trial with a control group, randomized with parallel groups, on 75 patients, was used for randomization using a table of random numbers.
Settings and conduct
This study is conducted as a non-blinded clinical trial on patients who are candidates for pulmonary endarterectomy surgery referred to Masih Deneshvari Hospital in Tehran, Iran. Patients enter the study after providing full explanations and signing a written consent form.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for endarterectomy surgery based on the results of echocardiography, angiography, and CPET and examinations by the treating physician at Masih Daneshvari Hospital. Exclusion criteria: if the patient does not want to exercise, relapse of the disease, or underlying disease such as diabetes and arrhythmia.
Intervention groups
The first group includes patients who perform respiratory rehabilitation exercises only after surgery. The second group includes patients who perform respiratory rehabilitation exercises before and after surgery, and the third group (control group) only receives routine treatments and does not receive any exercise intervention.
Main outcome variables
Right ventricular pressure, pulmonary artery systolic and diastolic pressure, cardiac output, pulmonary vascular resistance, pulmonary artery compliance, left ventricular extensor index, pulmonary artery systolic pressure at rest, 6-minute walking test distance, maximum VO2, level of fatigue during activity, dyspnea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230417057933N2
Registration date: 2023-04-27, 1402/02/07
Registration timing: prospective

Last update: 2023-04-27, 1402/02/07
Update count: 0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Zargham_Hossein Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2002
Email address
zarghamahmadi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of respiratory rehabilitation before and after pulmonary endarterectomy (PEA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH)
Public title
The effect of respiratory rehabilitation in patients with chronic thromboembolic pulmonary hypertension (CTEPH)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for endarterectomy based on the results of echocardiography, angiography and CPET and examinations of the attending physician at Masih Daneshvari Hospital.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit and random number table randomization tool. For randomization, we use a table consisting of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move down row by row. For three groups, we put numbers 1 to 3 for the first group, numbers 4 to 6 for the second group, and numbers 7 to 9 for the third group. We continue the above process until three groups are completed.
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
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-04-07, 1402/01/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1402.003

Health conditions studied

1

Description of health condition studied
Chronic thromboembolic pulmonary hypertension
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension

Primary outcomes

1

Description
Right ventricular pressure
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Catheterization

2

Description
Pulmonary artery systolic and diastolic pressure
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Catheterization

3

Description
Mean of pulmonary artery pressure
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Catheterization

4

Description
Cardiac output
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Catheterization

5

Description
Test distance of 6 minutes walk
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
6 minute walk test

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: In this group, patients with mild symptoms do respiratory rehabilitation exercises only after surgery. They do 15 minutes of cycling with an intensity of 70% of the maximum test power and 6 minutes of walking. Patients with moderate symptoms perform 15 minutes of cycling activity with an intensity of 60% of the maximum power of the 6-minute walking test.
Category
Rehabilitation

2

Description
The second intervention group: in this group, patients perform respiratory rehabilitation exercises before and after surgery. In the pre-surgery rehabilitation program, patients with mild symptoms do 15 minutes of cycling activity with an intensity of 70% of the maximum test power of 6 minutes of walking, and patients with moderate symptoms do 15 minutes of cycling activity with an intensity of 60% of the maximum test power of 6 minutes of walking. . In the rehabilitation program after surgery: after surgery and with the opinion of a specialist doctor and surgeon, all patients will do 6 minutes of walking in each session for 20 bicycle activities with an intensity of 50 to 70% of the maximum test power. In the second week of rehabilitation, 5 minutes are added to the activity time.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Zargham Hosein Ahmadi
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 2020
Email
zarghamahmadi@hotmail.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
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2243 9781
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
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
Zargham Hosein Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac surgery
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
Email
zarghamahmadi@hotmail.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
Researcher
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 2020
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
Undecided - It is not yet known if there will be a plan to make this available
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