Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
High SpO2 group
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).
Intervention: High-flow nasal cannula (Other)
Low SpO2 group
In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).
Intervention: Low SpO2 (Other)
Outcomes
Primary Outcomes
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation
Time Frame: four weeks
Secondary Outcomes
- Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)
- Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation(four weeks)