Chronic Respiratory Failure Clinical Trial
Official title:
Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
NCT number | NCT04481295 |
Other study ID # | 2019-24 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2020 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Japan | National Hospital Organization Minami Kyoto Hospital | Joyo | Kyoto |
Lead Sponsor | Collaborator |
---|---|
National Hospital Organization Minami Kyoto Hospital |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation | four weeks | ||
Secondary | Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation | four weeks |
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