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Evaluation of the effectiveness of pulmonary rehabilitation on cardiopulmonary parameters and quality of life in patients with scleroderma with pulmonary involvement

Phase 3
Recruiting
Conditions
Systemic Scleroderma.
M34.81
Systemic sclerosis with lung involvement
Registration Number
IRCT20151126025252N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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