Utility of Breath-holding Test in Systemic Sclerosis

Overview

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

Full Title of Study: “Utility of Breath-holding Test for Assessment of Pulmonary Disease Severity in Patients With Systemic Sclerosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

Detailed Description

Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc. Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc. Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.

Interventions

  • Other: scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT
    • Participants will perform the SHAQ. BHT and 6MWT will be performed in the randomized way for each participant. For BHT, the participants will be told to sit comfortably on a chair, and breath normally. After 1 minute, they were required to make a maximum expiration followed by a maximum inspiration and to hold the breath as long as possible at maximum inspiratory level. This procedure was repeated three times, with 5-minute intervals between the tests. 6MWT will be performed according to the ATS guidelines. Information on CXR, TTE, and PFT (FVC%, DLCO%) will be obtained from the medical record if the data was obtained within 3 months. If not, the tests will be performed. BHT and PFT will be followed by six months after the first breath-holding test to confirm the responsiveness. Additional 30 patients with systemic sclerosis will be collected to perform the test-retest reliability of BHT.

Arms, Groups and Cohorts

  • Experimental: Systemic sclerosis group
    • Systemic sclerosis diagnosis according to 2013 American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) classification criteria

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of breath-holding test with Borg Dyspnea Index
    • Time Frame: Day 1 at inclusion
    • Borg Scale on a 0-10 point

Secondary Measures

  • Correlation of breath-holding time with 6 minute walk test (6MWT) distance
    • Time Frame: Day 1 at inclusion
    • 6MWT distance measured in meters according to American Thoracic Society guidelines
  • Correlation of breath-holding time with oxygen saturation during 6MWT
    • Time Frame: Day 1 at inclusion
    • Oxygen saturation monitored by wearable pulse oximeter (Radius PPGā„¢ Tetherless Pulse Oximetry, Masimo Corp., Irvine, CA, USA)
  • Correlation of breath-holding time with pulmonary function indices
    • Time Frame: Day 1 at inclusion
    • Pulmonary function indices including FVC (%) and DLCO (%)
  • Correlation of breath-holding time with data on the echocardiography
    • Time Frame: Day 1 at inclusion
    • Echocardiography including left ventricular ejection fraction and pulmonary arterial systolic pressure (mmHg)
  • Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ)
    • Time Frame: Day 1 at inclusion
    • SHAQ ranging from 0 to 3

Participating in This Clinical Trial

Inclusion Criteria

  • A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria – Must understand and voluntarily sign an informed consent form including writing consent for data protection Exclusion Criteria:

  • The resting oxygen saturation by pulse oximetry < 90% in room air – Unstable angina or myocardial infarction during the previous month – Patients considered unable to the breath-holding test or 6 minute walk test

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eun Bong Lee, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Eun Bong Lee, MD PhD, Principal Investigator, Seoul National University College of Medicine
    • Jina Yeo, MD, Study Director, Seoul National University College of Medicine
  • Overall Contact(s)
    • Eun Bong Lee, MD PhD, 82-2-2072-3944, leb7616@snu.ac.kr

References

Hachulla E, Launay D. Diagnosis and classification of systemic sclerosis. Clin Rev Allergy Immunol. 2011 Apr;40(2):78-83. doi: 10.1007/s12016-010-8198-y. Review.

Morelli S, Ferrante L, Sgreccia A, Eleuteri ML, Perrone C, De Marzio P, Balsano F. Pulmonary hypertension is associated with impaired exercise performance in patients with systemic sclerosis. Scand J Rheumatol. 2000;29(4):236-42.

Vandecasteele E, De Pauw M, De Keyser F, Decuman S, Deschepper E, Piette Y, Brusselle G, Smith V. Six-minute walk test in systemic sclerosis: A systematic review and meta-analysis. Int J Cardiol. 2016 Jun 1;212:265-73. doi: 10.1016/j.ijcard.2016.03.084. Epub 2016 Mar 25. Review.

Impens AJ, Wangkaew S, Seibold JR. The 6-minute walk test in scleroderma–how measuring everything measures nothing. Rheumatology (Oxford). 2008 Oct;47 Suppl 5:v68-9. doi: 10.1093/rheumatology/ken273.

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

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