Functional Exercise Tests in Patients With Systemic Sclerosis

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Measurement Properties and Performance of Functional Exercise Tests in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04650659
• Other study ID #: SSc6MWT2020
• Secondary ID: 1-16-02-270-20
• Status: Active, not recruiting
• Start date: July 27, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to examine the validity of peripheral oxygen saturation measurement during the 6-minute walk test in patients with Systemic Sclerosis (SSc) and to examine the utility of two other functional tests as markers of pulmonary involvement in patients with SSc.

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 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. Additionally, nailfold videocapillaroscopy (NVC) will be performed on every patient to assess the capillary density of the nailfold of the fingers. Furthermore, to study the effect of SSc on bone, a high resolution peripheral quantitative computed tomography (HRpQCT) scan of radius and distal interphalangeal joints (DIP)/distal phalanges will be performed.

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). The correlation between the capillary density of the nailfold and the SpO2 measured on the finger will be assessed. The correlation between capillary density of the nailfold and bone status in the fingers and distal radius assessed with HRpQCT will be evaluated, and HRpQCT images will be compared with conventional radiography and DEXA. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Systemic Sclerosis according to the ACR/EULAR 2013 criteria

• Provided written informed consent

Exclusion Criteria:

• Overlap syndrome (except for rheumatoid arthritis and Sjögren syndrome)

• Recent or ongoing lung infection

• Other major comorbidities that could affect the functional exercise tests.

• Pregnancy

• Unable to understand the patient information

Related Conditions & MeSH terms

• Hypertension
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Arterial Hypertension
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Diagnostic Test:
• 6-minute walk test part one
Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. In patients who will accept an arterial line will be placed and blood gas will be analyzed.
• 6-minute walk test part two
Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. No arterial line will be placed.
• 1-minute sit-to-stand test
Measurement of: Number of repetitions, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured on the three anatomical locations mentioned above.
• 4-meters gait speed test
Measurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed.
• Nailfold videocapillaroscopy
Capillary density measurement of: The finger with the probe and the average of all the fingers. NVC with 200 x magnification will be performed on the 2nd to 5th finger on both hands.
• HR-pQCT
Imaging: One arm is scanned in a 9 mm-long volume of the distal radius (110 slices), and the distal part of the 2nd to 5th finger on both hands are scanned in a 36,08 mm-long volume (440 slices) at baseline and after 1 year.
• Hand x-ray
Imaging: Hand x-ray was performed on patients scanned with HR-pQCT, unless images were already available (= 1 year).
• DEXA
Imaging: A bone density (DEXA) scan was performed on patients scanned with HR-pQCT, unless it was already available (= 2 years).

Locations

Country	Name	City	State
Denmark	The Department of Rheumatology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the validity of peripheral oxygen saturation measurement during 6-minute walk test in patients with Systemic Sclerosis.	The agreement between the peripheral oxygen saturation measured on the forehead, finger and earlobe and the arterial oxygen saturation from the blood gas analysis will be examined.	1 hour
Secondary	Examine the correlation between the 6-minute walk test, the 1-minute sit-to-stand test, and the 4-meter gait speed test in patients with Systemic Sclerosis.	The agreement between the 6-minute walk test, the 1-minute sit-to-stand test, and the 4-meter gait speed test in patients with Systemic Sclerosis.	1 hour
Secondary	Investigate the correlation between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.	The agreement between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.	1 hour