Utility of Breath-holding Test in Systemic Sclerosis

NCT04484948 | Completed DMC

• 1 other identifier: H-2006-054-1131
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Sclerosis

Keywords

Breath-holding test; Six minute walk test; Systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• Correlation of breath-holding test with Borg Dyspnea Index

  Borg Scale on a 0-10 point

  Day 1 at inclusion

Secondary Outcomes (5)

• Correlation of breath-holding time with 6 minute walk test (6MWT) distance

  Day 1 at inclusion

• Correlation of breath-holding time with oxygen saturation during 6MWT

  Day 1 at inclusion

• Correlation of breath-holding time with pulmonary function indices

  Day 1 at inclusion

• Correlation of breath-holding time with data on the echocardiography

  Day 1 at inclusion

• Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ)

  Day 1 at inclusion

Other Outcomes (5)

• Changes of oxygen saturation during breath-holding test

  Day 1 at inclusion

• Changes of oxygen saturation during of 6MWT

  Day 1 at inclusion

• Responsiveness of breath-holding test

  Month 6 at inclusion

Study Arms (1)

Systemic sclerosis group

EXPERIMENTAL

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

Other: scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT

Interventions

scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT OTHER

1. Participants will perform the SHAQ. 2. BHT and 6MWT will be performed in the randomized way for each participant. 3. 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. 4. 6MWT will be performed according to the ATS guidelines. 5. 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. 6. BHT and PFT will be followed by six months after the first breath-holding test to confirm the responsiveness. 7. Additional 30 patients with systemic sclerosis will be collected to perform the test-retest reliability of BHT.

Systemic sclerosis group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (6)

• 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.

  PMID: 20143182 BACKGROUND

• 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. doi: 10.1080/030097400750041389.

  PMID: 11028845 BACKGROUND

• 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.

  PMID: 27057932 BACKGROUND

• 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.

  PMID: 18784152 BACKGROUND

• 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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Yeo J, Kim JY, Kim MH, Park JW, Park JK, Lee EB. Utility of the breath-holding test in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Oct 6;61(10):4113-4118. doi: 10.1093/rheumatology/keac020.

  PMID: 35040945 DERIVED

Related Links

• Azza Slim, Abir Hedhli, Sana Cheikh Rouhou, et al. Maximal voluntary inspiratory breath holding time test in patients with chronic obstructive pulmonary disease. European Respiratory Journal 2018 52:PA4053

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Butylated Hydroxytoluene

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Eun Bong Lee, MD PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

• Jina Yeo, MD

  Seoul National University College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: August 12, 2020
• Primary Completion: January 29, 2021
• Study Completion: May 31, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

KR (1)