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Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04481295
Enrollment
32
Registered
2020-07-22
Start date
2020-07-18
Completion date
2025-07-31
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure, Exercise Capacity, High-flow Nasal Cannula, Optimal SpO2 Value

Keywords

HFNC, 6MWD

Brief summary

The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Detailed description

In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear. The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Interventions

OTHERHigh-flow nasal cannula

The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Low SpO2

Sponsors

National Hospital Organization Minami Kyoto Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion criteria

* Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure. * Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month. * Subjects with changes in LTOT prescription flow within the last month * Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.

Design outcomes

Primary

MeasureTime frame
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitationfour weeks

Secondary

MeasureTime frame
Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitationfour weeks
Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitationfour weeks

Countries

Japan

Contacts

Primary ContactYuichi Chihara
yc.r03107@gmail.com81-774-52-0065

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026