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Functional Exercise Tests in Patients With Systemic Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04650659
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Aarhus
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Klaus Søndergaard, MD, PhDAmanda Lynggaard Riis, StudentEsben Uggerby Næser, MD, PhDKatja Thorup Aaen, StudentEllen-Margrethe Hauge, ProfessorFrederik Cosedis Enevoldsen, StudentRasmus Klose Jensen, MD, PhDJosephine Therkildsen, MD
Principal Investigator Affiliation Department of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DKDepartment of Rheumatology, Aarhus University Hospital, DK
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Arterial Hypertension, Acroosteolysis
Additional Details

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.

Arms & Interventions

Arms

: Part one of the project

83 patients with Systemic Sclerosis will perform three functional exercise tests on the same day. All 83 patients will be examined with NVC. Moreover, HRpQCT will be performed on all patients at baseline and after 1 year.

: Part two of the project

Half of the patients from part one of the project will be invited to repeat the three functional exercise tests approximately one week later in reverse order to determine test-retest reliability.

Interventions

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.

Diagnostic Test: - 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.

Diagnostic Test: - 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.

Diagnostic Test: - 4-meters gait speed test

Measurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed.

Diagnostic Test: - 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.

Diagnostic Test: - 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.

Diagnostic Test: - Hand x-ray

Imaging: Hand x-ray was performed on patients scanned with HR-pQCT, unless images were already available (≤ 1 year).

Diagnostic Test: - DEXA

Imaging: A bone density (DEXA) scan was performed on patients scanned with HR-pQCT, unless it was already available (≤ 2 years).

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International Sites

Aarhus, Denmark

Status

Address

The Department of Rheumatology, Aarhus University Hospital

Aarhus, , 8200

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