Nasal High-flow Oxygen Therapy During Rehabilitive Exercise Training in ILD (PID-OX)
2026년 6월 25일 업데이트: Frédéric Hérengt
Does Nasal High-Flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
Although uncommon, interstitial lung diseases (ILDs), and particularly idiopathic pulmonary fibrosis (IPF), are progressive, irreversible, and ultimately fatal without treatment. Pharmacological therapies can slow the decline in forced vital capacity (FVC) and six-minute walk distance (6MWD), but they do not improve exercise-related respiratory limitations or quality of life.
Therefore, pulmonary rehabilitation (PR) is recommended for patients with a confirmed diagnosis of ILD/IPF who experience exercise limitation and significant functional impairment. However, the benefits of PR remain modest, and the optimal rehabilitation strategies for these patients have yet to be defined, particularly given the severe dyspnea and often profound exertional hypoxemia that characterize the disease.
To optimize the effects of PR, especially exercise training, the use of high-flow nasal oxygen (HFNO) during exercise has been proposed in certain respiratory conditions such as chronic obstructive pulmonary disease (COPD). By improving oxygenation and exercise tolerance, HFNO applied during exercise training sessions may enhance the effectiveness of pulmonary rehabilitation.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Auvergne-Rhône-Alpes
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Dieulefit, Auvergne-Rhône-Alpes, 프랑스, 26220
- Association Dieulefit Santé
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ≥18 years.
- Confirmed diagnosis of interstitial lung disease (ILD).
- Indication for pulmonary rehabilitation according to current guidelines, defined as exercise limitation associated with significant functional impairment.
- Clinically stable disease with no recent exacerbation requiring treatment modification within the previous 3 months.
- Affiliation with a health insurance/social security system.
- Ability to understand the study procedures and provide written informed consent.
Non-inclusion Criteria:
- Inability to perform cycle ergometer exercise testing.
- Participation in a pulmonary rehabilitation program within the previous 6 months.
- Any contraindication to exercise testing according to standard clinical practice.
- Inability to provide informed consent.
- Current participation in another interventional study during an exclusion period.
- Pregnant or breastfeeding women.
- Individuals deprived of liberty by judicial or administrative decision.
- Adults under legal protection or guardianship.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Nasal high-flow oxygen therapy
Nasal high-flow oxygen therapy (flow= 30-70 L/min; inspired fraction of O2= 0.50)
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Participants will undergo a standardized 4-week pulmonary rehabilitation program consisting of respiratory therapy exercises (20min), cycle ergometer endurance training, outdoor walking, calisthenics, and muscle strengthening exercises, performed 5 days per week for a total of 20 sessions.
During cycle ergometer endurance training, participants will receive NHFO2.
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활성 비교기: Conventional oxygen therapy
Conventional oxygen therapy (nasal canula; flow= 4-9 L/min; inspired fraction of O2= 1.0)
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Participants will undergo a standardized 4-week pulmonary rehabilitation program consisting of respiratory therapy exercises (20min), cycle ergometer endurance training, outdoor walking, calisthenics, and muscle strengthening exercises, performed 5 days per week for a total of 20 sessions.
During cycle ergometer endurance training, participants will receive conventional O2 therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Constant Work Rate Endurance Time (CWRET)
기간: Baseline and end of the 4-week PR program.
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Endurance time measured during a constant-load exercise test performed at 70% of peak work rate (PWR) in room air determined during baseline incremental cardiopulmonary exercise testing.
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Baseline and end of the 4-week PR program.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Six-Minute Walk Distance
기간: Baseline and end of the 4-week pulmonary rehabilitation.
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Distance walked during the 6-Minute Walk Test.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Dyspnea, Leg Discomfort and Rate of Percieved Exertion (RPE)
기간: Dyspnea and Leg Discomfort : during constant-load exercise test and 6-min walk test, at baseline and end of 4-week PR. Dyspnea and RPE : during each of the 20 exercise training sessions on a bicycle ergometer.
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Using the modified CR10 Borg scale (ranging from 0 [nothing at all] to 10 [maximal]) for dyspnea and leg discomfort; using the 6 (no exertion at all) - 20 (maximum exertion) Borg scale for RPE.
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Dyspnea and Leg Discomfort : during constant-load exercise test and 6-min walk test, at baseline and end of 4-week PR. Dyspnea and RPE : during each of the 20 exercise training sessions on a bicycle ergometer.
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Pulmonary responses to exercise
기간: Baseline and end of the 4-week pulmonary rehabilitation.
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Pulmonary exercise parameters, including ventilation (VE, L/min), gas exchange (VO2, VCO2, L/min), assessed during a cardiopulmonary exercise test (CPET) and during constant-load cycle ergometer endurance tests.
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Baseline and end of the 4-week pulmonary rehabilitation.
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Oxygen saturation
기간: During each of the 20 exercise training sessions on a bicycle ergometer.
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By pulse oximetry
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During each of the 20 exercise training sessions on a bicycle ergometer.
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Heart Rate
기간: Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Using electrocardiogram, in beats/min
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Continuous monitoring throughout the cardiopulmonary test and during each of the 20 exercise training sessions on a bicycle ergometer.
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Power
기간: During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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During each of the 20 exercise training sessions on a bicycle ergometer. During the CPET, baseline and end of the 4-week pulmonary rehabilitation
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Near Infrared Spetroscopy
기간: Baseline and end of the 4-week PR
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Of the Vastus Lateralis, used during the CPET and CWRET.
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Baseline and end of the 4-week PR
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King's Brief Interstitial Lung Disease (K-BILD)
기간: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (worst) to 100 (better)
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Baseline and end of the 4-week pulmonary rehabilitation
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modified Medical Research Council (mMRC)
기간: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 4 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Hospital Anxiety and Depression Scale (HADS)
기간: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 21 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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Pichot Fatigue Scale
기간: Baseline and end of the 4-week pulmonary rehabilitation
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Ranging from 0 (better) to 32 (worst)
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Baseline and end of the 4-week pulmonary rehabilitation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.
- Rochester CL, Alison JA, Carlin B, Jenkins AR, Cox NS, Bauldoff G, Bhatt SP, Bourbeau J, Burtin C, Camp PG, Cascino TM, Dorney Koppel GA, Garvey C, Goldstein R, Harris D, Houchen-Wolloff L, Limberg T, Lindenauer PK, Moy ML, Ryerson CJ, Singh SJ, Steiner M, Tappan RS, Yohannes AM, Holland AE. Pulmonary Rehabilitation for Adults with Chronic Respiratory Disease: An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2023 Aug 15;208(4):e7-e26. doi: 10.1164/rccm.202306-1066ST.
- Al Chikhanie Y, Veale D, Verges S, Herengt F. The effect of heated humidified nasal high flow oxygen supply on exercise tolerance in patients with interstitial lung disease: A pilot study. Respir Med. 2021 Sep;186:106523. doi: 10.1016/j.rmed.2021.106523. Epub 2021 Jun 29.
- Kozu R, Senjyu H, Jenkins SC, Mukae H, Sakamoto N, Kohno S. Differences in response to pulmonary rehabilitation in idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease. Respiration. 2011;81(3):196-205. doi: 10.1159/000315475. Epub 2010 May 27.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 8월 1일
기본 완료 (실제)
2025년 5월 31일
연구 완료 (실제)
2025년 5월 31일
연구 등록 날짜
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
2026년 6월 25일
처음 게시됨 (실제)
2026년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 25일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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