Systemic Scleroderma. Systemic sclerosis with lung involvement
Conditions
Interventions
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, unde
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSamira Salehi
Tehran University of Medical Sciences
Outcome results
None listed