Functional Exercise Tests in Patients With Systemic Sclerosis

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

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).

Sponsors & Collaborators

• The Danish Rheumatism Association

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Klaus Søndergaard, MD, PhD · Department of Rheumatology, Aarhus University Hospital, DK

• Amanda Lynggaard Riis, Student · Department of Rheumatology, Aarhus University Hospital, DK

• Esben Uggerby Næser, MD, PhD · Department of Rheumatology, Aarhus University Hospital, DK

• Katja Thorup Aaen, Student · Department of Rheumatology, Aarhus University Hospital, DK

• Ellen-Margrethe Hauge, Professor · Department of Rheumatology, Aarhus University Hospital, DK

• Frederik Cosedis Enevoldsen, Student · Department of Rheumatology, Aarhus University Hospital, DK

• Rasmus Klose Jensen, MD, PhD · Department of Rheumatology, Aarhus University Hospital, DK

• Josephine Therkildsen, MD · Department of Rheumatology, Aarhus University Hospital, DK

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-27

Primary Completion

2023-01-31

Completion

2023-01-31

FDA Device

Yes

Countries

• Denmark

Study Locations