Scleroderma, SystemicNCT04650659
Functional Exercise Tests in Patients With Systemic Sclerosis
An observational study of Scleroderma, Systemic and Lung Diseases, Interstitial, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Arterial Hypertension
- What is being tested?
- 6-minute walk test part one, 6-minute walk test part two and 1-minute sit-to-stand test
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jul 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited if they have a clinical course at the Department of Rheumatology, Aarhus University Hospital (>500 patients with Scleroderma)
Who may be able to join
- Diagnosed with Systemic Sclerosis according to the ACR/EULAR 2013 criteria
- Provided written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
The Department of Rheumatology, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Measurement Properties and Performance of Functional Exercise Tests in Patients With Systemic Sclerosis
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.
Read the detailed 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.
- Conditions
- Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Arterial Hypertension, Acroosteolysis
- Being tested
- 6-minute walk test part one, 6-minute walk test part two, 1-minute sit-to-stand test, 4-meters gait speed test, Nailfold videocapillaroscopy
- Keywords
- 6-Minute Walk Test, Scleroderma, Systemic, Oximetry, Exercise test, Raynaud Disease, HR-pQCT, Nailfold videocapillaroscopy
- Medical subject headings
- Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Arterial Hypertension, Acro-Osteolysis, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk test part oneDiagnostic test
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 twoDiagnostic test
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 testDiagnostic 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 testDiagnostic test
Measurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed.
Nailfold videocapillaroscopyDiagnostic test
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-pQCTDiagnostic test
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-rayDiagnostic test
Imaging: Hand x-ray was performed on patients scanned with HR-pQCT, unless images were already available (≤ 1 year).
DEXADiagnostic test
Imaging: A bone density (DEXA) scan was performed on patients scanned with HR-pQCT, unless it was already available (≤ 2 years).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 6-minute walk test part one; Diagnostic Test: 1-minute sit-to-stand test; Diagnostic Test: 4-meters gait speed test; Diagnostic Test: Nailfold videocapillaroscopy; Diagnostic Test: HR-pQCT; Diagnostic Test: Hand x-ray; Diagnostic Test: DEXA | |
| 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. Receives: Diagnostic Test: 6-minute walk test part two; Diagnostic Test: 1-minute sit-to-stand test; Diagnostic Test: 4-meters gait speed test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start27 Jul 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Responsible party
- Sponsor
- Investigators
- Klaus Søndergaard, MD, PhD, Study chair, Department of Rheumatology, Aarhus University Hospital, DKAmanda Lynggaard Riis, Student, Principal investigator, Department of Rheumatology, Aarhus University Hospital, DKEsben Uggerby Næser, MD, PhD, Study director, Department of Rheumatology, Aarhus University Hospital, DKKatja Thorup Aaen, Student, Principal investigator, Department of Rheumatology, Aarhus University Hospital, DKEllen-Margrethe Hauge, Professor, Study chair, Department of Rheumatology, Aarhus University Hospital, DKFrederik Cosedis Enevoldsen, Student, Principal investigator, Department of Rheumatology, Aarhus University Hospital, DKRasmus Klose Jensen, MD, PhD, Study director, Department of Rheumatology, Aarhus University Hospital, DKJosephine Therkildsen, MD, Study director, Department of Rheumatology, Aarhus University Hospital, DK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650659
- Sponsor's protocol ID
- SSc6MWT2020
- Other IDs
- 1-16-02-270-20
- Status last verified
- May 2022
- First submitted
- 23 Nov 2020
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Elkjaer AL, Naeser EU, Aaen KT, Hovgaard HL, Juhl-Olsen P, Bendstrup E, Sondergaard K. Validity and reliability of measurement of peripheral oxygen saturation during the 6-Minute Walk Test in patients with systemic sclerosis. Rheumatol Int. 2024 Apr;44(4):611-620. doi: 10.1007/s00296-024-05532-5. Epub 2024 Feb 10.
PubMed 38340159
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Properties and Performance of Functional Exercise Tests in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04650659
- Acronym / sponsor ID
- SSc6MWT2020
- Conditions
- Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Arterial Hypertension, Acroosteolysis
- Keywords
- 6-Minute Walk Test, Scleroderma, Systemic, Oximetry, Exercise test, Raynaud Disease, HR-pQCT, Nailfold videocapillaroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part one of the project | – | Diagnostic Test: 6-minute walk test part one, Diagnostic Test: 1-minute sit-to-stand test, Diagnostic Test: 4-meters gait speed test, Diagnostic Test: Nailfold videocapillaroscopy, Diagnostic Test: HR-pQCT, Diagnostic Test: Hand x-ray, Diagnostic Test: DEXA83 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 | – | Diagnostic Test: 6-minute walk test part two, Diagnostic Test: 1-minute sit-to-stand test, Diagnostic Test: 4-meters gait speed testHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited if they have a clinical course at the Department of Rheumatology, Aarhus University Hospital (>500 patients with Scleroderma)
Key inclusion criteria (2 listed)
- Diagnosed with Systemic Sclerosis according to the ACR/EULAR 2013 criteria
- Provided written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk test part oneMeasurement 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 | Part one of the project |
| 6-minute walk test part twoMeasurement 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 | Part two of the project |
| 1-minute sit-to-stand testMeasurement 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 | Part one of the project, Part two of the project |
| 4-meters gait speed testMeasurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed. | Diagnostic test | Part one of the project, Part two of the project |
| Nailfold videocapillaroscopyCapillary 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 | Part one of the project |
| HR-pQCTImaging: 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 | Part one of the project |
| Hand x-rayImaging: Hand x-ray was performed on patients scanned with HR-pQCT, unless images were already available (≤ 1 year). | Diagnostic test | Part one of the project |
| DEXAImaging: A bone density (DEXA) scan was performed on patients scanned with HR-pQCT, unless it was already available (≤ 2 years). | Diagnostic test | Part one of the project |
Primary outcome
Examine the validity of peripheral oxygen saturation measurement during 6-minute walk test in patients with Systemic Sclerosis.
Time frame: 1 hour
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.
2 secondary outcomes
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.
Time frame: 1 hour
Investigate the correlation between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 38340159Elkjaer AL, Naeser EU, Aaen KT, Hovgaard HL, Juhl-Olsen P, Bendstrup E, Sondergaard K. Validity and reliability of measurement of peripheral oxygen saturation during the 6-Minute Walk Test in patients with systemic sclerosis. Rheumatol Int. 2024 Apr;44(4):611-620. doi: 10.1007/s00296-024-05532-5. Epub 2024 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Søndergaard, MD, PhD study chair
Department of Rheumatology, Aarhus University Hospital, DK
Amanda Lynggaard Riis, Student principal investigator
Department of Rheumatology, Aarhus University Hospital, DK
Esben Uggerby Næser, MD, PhD study director
Department of Rheumatology, Aarhus University Hospital, DK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, Systemic and Lung Diseases, Interstitial, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the validity of peripheral oxygen saturation measurement during 6-minute walk test in patients with Systemic Sclerosis. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.