Protocol summary

Study aim
Evaluation of the effect of pulmonary rehabilitation on improving cardiac output, quality of life, dyspnea and spirometeric parameters including FVC and TLC
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3, on 60 patients For randomization, the table of random numbers in a statistics book or computer-generated random numbers is used.
Settings and conduct
Aerobic and anaerobic exercises are given to all patients in 24 sessions and at the same time in the intervention group, pulmonary rehabilitation in patients is given by a sports medicine specialist in Shariati Hospital . Patients fill in the shortness of breath and quality of life questionnaire at the beginning and end of the study, and undergo a cardiopulmonary exercise test.The person performing the exercise test and the sports medicine specialist have no information about the patients' condition and the results of the tests.
Participants/Inclusion and exclusion criteria
Scleroderma patients according to Eular 2013 Less than 80 % or Ground Glass more than 10% in CT scan No drug change during the last 3 months Ability to do exercise ; Overlap syndrome or MCTD Contraindications for cardiopulmonary exercise test
Intervention groups
Scleroderma patients with pulmonary involvement Rehabilitation with aerobic and anaerobic exercise within 24 sessions and Simultaneously pulmonary rehabilitation for intervention group
Main outcome variables
Quality of Life; dyspnea; Cardiac output; FVC; TLC; VO2 max

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151126025252N1
Registration date: 2022-05-11, 1401/02/21
Registration timing: registered_while_recruiting

Last update: 2022-05-11, 1401/02/21
Update count: 0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
hoda kavosi
Name of organization / entity
tehran university,rheumatology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0065
Email address
h-kavosi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of eight weeks of pulmonary rehabilitation on cardiopulmonary parameters and quality of life in patients with scleroderma with pulmonary involvement
Public title
Evaluation of the effectiveness of pulmonary rehabilitation on cardiopulmonary parameters and quality of life in patients with scleroderma with pulmonary involvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with scleroderma according to the 2013 Eular criteria FVC less than 80 percent or CT involvement more than 10 percent No change in the medications taken by patients during the last 3 months These patients should have the ability to do exercise in the hospital and at home
Exclusion criteria:
Overlap syndrome and MCTD Inability to perform exercise Contraindications to CPET include:1) Unstable angina, 2) Uncontrolled arrhythmia, 3) Severe aortic stenosis,4) Arterial oxygen with pulse oximetry less than 85% in room air,5) Severe untreated arterial hypertension at rest (SBP200mmHg) (DBP120mmmHg ), 6) Hypertrophic cardiomyopathy 7) Significant orthopedic disorder, 8) Mental disorder,9) Clinical signs of heart failure (pulmonary or peripheral edema) or EF less than 50%, 10) Severe valvular heart disease,11) Pulmonary hypertension >50 mmHg, 12) Acute pulmonary embolism - 13) Sinus tachycardia more than 120,14) Pericarditis, 15) Acute myocarditis, 16) Uncompensated heart failure, 17) Acute systemic disease or fever, 18 ) Coronary disease in the last 4 weeks -19) Metabolic disease such as acute thyroiditis
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For random selection, patients are selected based on three steps and based on the randomization table including creating a random allocation sequence, hiding the allocation, and executing the random allocation sequence. Then, the table of random numbers in a statistical book or random numbers generated by the computer is used, by which patients are randomly placed in the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: Patients do not know whether they are in the intervention or control group and both groups are given exercise. Clinical caregiver: does not know the demographic results and information of patients' respiratory tests and CPET Consequence assessor: does not know the demographic status and type of intervention The researcher is not blind and the study is double-blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gastroenterology and Liver Diseases Research Institute،Tehran University of Medi
Street address
Norht Kargar Ave, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713137
Approval date
2021-10-17, 1400/07/25
Ethics committee reference number
IR.TUMS.DDRI.REC.1400.033

Health conditions studied

1

Description of health condition studied
Systemic Scleroderma
ICD-10 code
M34.81
ICD-10 code description
Systemic sclerosis with lung involvement

Primary outcomes

1

Description
Shortness of breath
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on the St. George Questionnaire

2

Description
Quality of life
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on SHAQ questionnaire

3

Description
Cardiac output
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on echocardiography

4

Description
TLC: Total lung capacity
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on spirometry

5

Description
VO2MAX: Oxygen consumption
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on cardiopulmonary exercise test.

6

Description
FVC: forced Vital capacity
Timepoint
The beginning of the study before the intervention and after 8 weeks
Method of measurement
based on spirometry

Secondary outcomes

1

Description
Modified Rodnan Skin Score : A standard used to measure the degree of skin involvement, which measures the degree of skin tightness in 17 different areas of the body.. In terms of Thickness, it has four degrees: Normal = 0, Mild = 1, Moderate = 2, Severe = 3.
Timepoint
At the beginning of the study (before the intervention) and after 8 weeks (the end of the intervention)
Method of measurement
Physical Examination

Intervention groups

1

Description
Intervention Group: Half of the patients with scleroderma with pulmonary involvement in the study undergo CPET and VO2MAX are measured and then, in addition to routine treatments, undergo 24 sessions of aerobic and anaerobic exercise, as well as 8 weeks of pulmonary rehabilitation, and finally undergo CPET again, and patients' cardiopulmonary parameters will be evaluated. All patients complete the SHAQ shortness of breath and quality of life questionnaire at the beginning and end of the study.
Category
Rehabilitation

2

Description
Control group: Half of the patients with scleroderma with pulmonary involvement in the study undergo CPET and VO2MAX are measured and then, in addition to routine treatments, undergo 24 sessions of aerobic and anaerobic exercise and finally undergo CPET again, and patients' cardiopulmonary parameters will be evaluated. All patients complete the SHAQ shortness of breath and quality of life questionnaire at the beginning and end of the study.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Hoda Kavosi
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0067
Email
h-kavosi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
6th floor, Tehran University of Medical Sciences, Ghods St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Samira Salehi
Position
Rheumatology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0067
Email
Salehi.Samira90@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hoda Kavosi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0067
Email
h-kavosi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Salehi
Position
Fellowship of Rheumatology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0067
Email
Salehi.Samira90@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no plan to publish the data independently and the data will be provided only at the request of the publisher of the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Items where patient information is known will not be published, but work results will be published along with statistical items
When the data will become available and for how long
after article publishing
To whom data/document is available
The main executor of the project
Under which criteria data/document could be used
.Data will be provided only at the request of the article publisher, but no re-analysis of the data is allowed.
From where data/document is obtainable
Project manager: Dr. Heda Kavousi, Rheumatology Research Center, Shariati Hospital, Tehran
What processes are involved for a request to access data/document
Formal request and review by the main executor of the project
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