Functional Exercise Tests in Patients With Systemic Sclerosis

NCT04650659 | Unknown FDA Device

• 2 other identifiers: SSc6MWT20201-16-02-270-20
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 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.

  1 hour

• Investigate the correlation between functional exercise tests and the severity of pulmonary involvement in patients with Systemic Sclerosis.

  1 hour

Study Arms (2)

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.

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.

Diagnostic Test: 6-minute walk test part two; Diagnostic Test: 1-minute sit-to-stand test; Diagnostic Test: 4-meters gait speed test

Interventions

6-minute walk test part one DIAGNOSTIC_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.

Part one of the project

6-minute walk test part two DIAGNOSTIC_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.

Part two of the project

1-minute sit-to-stand test DIAGNOSTIC_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.

Part one of the project; Part two of the project

4-meters gait speed test DIAGNOSTIC_TEST

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

Part one of the project; Part two of the project

Nailfold videocapillaroscopy DIAGNOSTIC_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.

Part one of the project

HR-pQCT DIAGNOSTIC_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.

Part one of the project

Hand x-ray DIAGNOSTIC_TEST

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

Part one of the project

DEXA DIAGNOSTIC_TEST

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

Part one of the project

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are recruited if they have a clinical course at the Department of Rheumatology, Aarhus University Hospital (\>500 patients with Scleroderma)

You may qualify if:

• Diagnosed with Systemic Sclerosis according to the ACR/EULAR 2013 criteria
• Provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Rheumatism Association: collaborator

Study Sites (1)

The Department of Rheumatology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38340159 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 mL arterial blood will be drawn from an arterial line before and after the 6MWT, respectively. In total 2 mL of arterial blood. Blood gas analysis will be performed.

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases, Interstitial; Pulmonary Arterial Hypertension; Acro-Osteolysis; Raynaud Disease

Interventions

Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension, Pulmonary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Osteolysis; Bone Resorption; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Study Officials

• Klaus Søndergaard, MD, PhD

  Department of Rheumatology, Aarhus University Hospital, DK

  STUDY CHAIR

• Amanda Lynggaard Riis, Student

  Department of Rheumatology, Aarhus University Hospital, DK

  PRINCIPAL INVESTIGATOR

• Esben Uggerby Næser, MD, PhD

  Department of Rheumatology, Aarhus University Hospital, DK

  STUDY DIRECTOR

• Katja Thorup Aaen, Student

  Department of Rheumatology, Aarhus University Hospital, DK

  PRINCIPAL INVESTIGATOR

• Ellen-Margrethe Hauge, Professor

  Department of Rheumatology, Aarhus University Hospital, DK

  STUDY CHAIR

• Frederik Cosedis Enevoldsen, Student

  Department of Rheumatology, Aarhus University Hospital, DK

  PRINCIPAL INVESTIGATOR

• Rasmus Klose Jensen, MD, PhD

  Department of Rheumatology, Aarhus University Hospital, DK

  STUDY DIRECTOR

• Josephine Therkildsen, MD

  Department of Rheumatology, Aarhus University Hospital, DK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: July 27, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

DK (1)