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Utility of Breath-holding Test in Systemic Sclerosis

NCT04484948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-06-02

No results posted yet for this study

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

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Eun Bong Lee, MD PhD · Seoul National University College of Medicine

  • Jina Yeo, MD · Seoul National University College of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2021-01-29
Completion
2023-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484948 on ClinicalTrials.gov