Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

Not Applicable

Recruiting

• Conditions: High-flow Nasal Cannula; Exercise Capacity; Optimal SpO2 Value; Chronic Respiratory Failure
• Interventions: Other: Low SpO2; Other: High-flow nasal cannula

• Registration Number: NCT04481295
• Lead Sponsor: National Hospital Organization Minami Kyoto Hospital

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 Timeline

• Study Start: 2020-07-18
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-25
• Last Update Posted: 2023-03-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low SpO2 group	Low SpO2	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).
High SpO2 group	High-flow nasal cannula	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).

Primary Outcome Measures

Name	Time	Method
Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation	four weeks

Secondary Outcome Measures

Name	Time	Method
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 nutritional status (body mass index(kg/m2) 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

Trial Locations

Locations (1)

National Hospital Organization Minami Kyoto Hospital; 🇯🇵 Joyo, Kyoto, Japan