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IRCT20151126025252N1 IRCT 2022-05-11 Tehran University of Medical Sciences Evaluation of the effectiveness of pulmonary rehabilitation on cardiopulmonary parameters and quality of life in patients with scleroderma with pulmonary involvement Evaluation of the effectiveness of eight weeks of pulmonary rehabilitation on cardiopulmonary parameters and quality of life in patients with scleroderma with pulmonary involvement 2021-12-22 anticipated 60 Complete https://irct.ir/trial/59445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Systemic Scleroderma. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Samira Salehi
North Kargar Ave
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0067 Salehi.Samira90@yahoo.com Tehran University of Medical Sciences scientific Hoda Kavosi
North Kargar Ave
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0067 h-kavosi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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 M34.81 Systemic sclerosis with lung involvement Rehabilitation Rehabilitation 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. 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. 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. Quality of life. Timepoint: The beginning of the study before the intervention and after 8 weeks. Method of measurement: based on SHAQ questionnaire. Cardiac output. Timepoint: The beginning of the study before the intervention and after 8 weeks. Method of measurement: based on echocardiography. TLC: Total lung capacity. Timepoint: The beginning of the study before the intervention and after 8 weeks. Method of measurement: based on spirometry. VO2MAX: Oxygen consumption. Timepoint: The beginning of the study before the intervention and after 8 weeks. Method of measurement: based on cardiopulmonary exercise test. FVC: forced Vital capacity. Timepoint: The beginning of the study before the intervention and after 8 weeks. Method of measurement: based on spirometry. 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. Tehran University of Medical Sciences Approved 2021-10-17 Ethics Committee of Gastroenterology and Liver Diseases Research Institute،Tehran University of Medi Norht Kargar Ave, Shariati Hospital Tehran Tehran Iran (Islamic Republic of)