Effects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot study

Phase 2

• Conditions: Chronic obstructive pulmonary disease, Idiopathic interstitial pneumonias; chronic respiratory failure

• Registration Number: JPRN-jRCTs031200400
• Lead Sponsor: Sakao Seiichiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1) Patients with COPD or IIPs who are attending a respiratory medicine in our hosuital
2) Patients who are 20 years of age or older at the time of obtaining consent
3) Patients who are able to walk independently
4) Patients who can accurately perform respiratory function tests and 6MWT
5) Patients whose condition is stable and who have not changed their treatment for more than three months
6) Patients who have been fully informed of the contents of this study and have given written consent
7) Patients who are in or have completed an outpatient rehabilitation program, have stable symptoms, and are not scheduled for an outpatient rehabilitation program during this study

Exclusion Criteria

1) Patients with severe orthopedic or central nervous system disease who need assistance with daily living
2) Patients who have been hospitalized for an exacerbation of an primary disease within the past six months
3) Patients with unstable cardiac disease
4) Patients with a history of other serious lung diseases such as occupational lung, sarcoidosis, airway hypersensitivity, malignant diseases, or lung infections caused by immunodeficiency
5) Patients with nasal obstruction and olfactory disturbances
6) Patients who are judged by the principal investigator/assistant physician to have a risk of compromising patient safety or to have difficulty complying with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Borg Scale before and after 6-minute walking test

Secondary Outcome Measures

Name	Time	Method
SpO2 (before and after 6MWT)<br>Pulse rate (before and after 6MWT)<br>6 minute walking distance<br>St. George`s Respiratory Questionnaire (SGRQ) <br>Steps/day<br>Nagasaki University Respiratory ADL Questionnaire (NRADL) <br>Quadriceps force<br>Grip force<br>Respiratory muscle force (PImax/PEmax)<br>pulmonary function<br>Dyspnea Language Questionnaire<br>Multidimensional Dyspnea Profile<br>Adverse event