The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kyoto
      • Joyo, Kyoto, Japan, 610-0113
        • National Hospital Organization Minami Kyoto Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: nasal high flow therapy
In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks.
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
No Intervention: oxygen therapy
In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walk distance (measured by six minutes walking test)
Time Frame: Four weeks
Four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Six minutes walking test (minimum Oxygen Saturation of Arterial Blood Measured by Pulse Oximeter (SpO2) et.)
Time Frame: Four weeks
Four weeks
Exercise tolerance test (exercise time et.)
Time Frame: Four weeks
Four weeks
Body composition measured by InBody (muscle mass et.)
Time Frame: Four weeks
Four weeks
Arterial blood gas
Time Frame: Four weeks
Four weeks
Inflammation (CRP et.)
Time Frame: Four weeks
Four weeks
Nutritional status (body mass index(kg/m2) et.)
Time Frame: Four weeks
Four weeks
Sympathetic activity (Catecholamine et.)
Time Frame: Four weeks
Four weeks
Dyspnea (Modified Borg scale)
Time Frame: Four weeks
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 26, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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