Functional Exercise Tests in Patients With Systemic Sclerosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lung Diseases, Interstitial
- Pulmonary Arterial Hypertension
- Scleroderma Systemic
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Systemic Sclerosis (SSc) is a connective tissue disease characterized by progressive organ fibrosis and vascular dysfunction. The leading causes of disease related morbidity and mortality are interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH). The 6-minute walk test (6MWT) is ...
Systemic Sclerosis (SSc) is a connective tissue disease characterized by progressive organ fibrosis and vascular dysfunction. The leading causes of disease related morbidity and mortality are interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH). The 6-minute walk test (6MWT) is a submaximal functional exercise test used to evaluate ILD and PAH in patients with SSc. Desaturations during the 6MWT have been considered suggestive of ILD and PAH. Still, the optimal method to measure peripheral oxygen saturation during the 6MWT in patients with SSc remains unclear. Furthermore, other functional exercise tests may also be useful in patients with SSc. Patients with SSc will perform three functional exercise tests, and approximately half of the patients will be invited to repeat the tests 1 week later to determine test-retest reliability. During the 6MWT, the peripheral oxygen saturation (SpO2) will be measured continuously on three anatomical locations. An arterial line will be placed, and blood will be drawn at baseline and after ended 6MWT and analysed for arterial oxygen saturation (SaO2). Bland-Altman plot will be used to display the agreement between SaO2 and SpO2 and between the two 6MWT. Further, the association between pulmonary variables and 6MWT results will be examined. Two alternative functional exercise tests will be investigated and compared to results in the 6MWT: The 1-minute sit-to-stand test (1STST) and the 4-meter gait speed test (4MGS). The association between the three functional exercise tests and clinical parameters in patients with SSc will be examined.
Tracking Information
- NCT #
- NCT04650659
- Collaborators
- The Danish Rheumatism Association
- Investigators
- Study Chair: Klaus Søndergaard, MD PhD Department of Rheumatology, Aarhus University Hospital, DK Principal Investigator: Amanda Lynggaard Riis, Student Department of Rheumatology, Aarhus University Hospital, DK Study Director: Esben Uggerby Næser, MD, PhD Department of Rheumatology, Aarhus University Hospital, DK