Clinical trial NCT02804243: The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Official title: The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Failure
Nasal High Flow Therapy
Rehabilitation
Exercise Endurance
Keywords: nasal high flow therapy
rehabilitation
exercise endurance
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with 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. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
* Subject who are unable to undergo rehabilitation.

Primary outcomes:
measure: Walk distance (measured by six minutes walking test)
timeFrame: Four weeks
Secondary outcomes:
measure: Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
timeFrame: Four weeks
measure: Exercise tolerance test (exercise time et.)
timeFrame: Four weeks
measure: Body composition measured by InBody (muscle mass et.)
timeFrame: Four weeks
measure: Arterial blood gas
timeFrame: Four weeks
measure: Inflammation (CRP et.)
timeFrame: Four weeks
measure: Nutritional status (body mass index(kg/m2) et.)
timeFrame: Four weeks
measure: Sympathetic activity (Catecholamine et.)
timeFrame: Four weeks
measure: Dyspnea (Modified Borg scale)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References:
citation: Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.