Clinical trial NCT04481295: Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation
Official title: Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-flow Nasal Cannula
Exercise Capacity
Chronic Respiratory Failure
Optimal SpO2 Value
Keywords: HFNC
6MWD
Lead sponsor: National Hospital Organization Minami Kyoto Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
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 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.

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, 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.

Primary outcomes:
measure: Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
Secondary outcomes:
measure: Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
measure: Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation
timeFrame: four weeks
Other outcomes:
Locations:
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
state: Kyoto
Study officials:
References: