High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Overview

To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Full Title of Study: “Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

Detailed Description

This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Interventions

  • Other: Usual care
    • Usual Care
  • Other: High flow nasal oxygen
    • High flow nasal oxygen

Arms, Groups and Cohorts

  • Active Comparator: Usual Care
    • Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
  • Experimental: High flow nasal oxygen
    • Patients will undergo pulmonary rehabilitation with high flow nasal oxygen

Clinical Trial Outcome Measures

Primary Measures

  • 6-minute walk distance
    • Time Frame: 6 weeks
    • It is the maximum distance walked in 6 minutes

Secondary Measures

  • COPD Assessment Test score
    • Time Frame: 3 weeks, 6 weeks and 1 month after completion of program
    • Chronic obstructive pulmonary disease assessment test (CAT) score
  • Hospital Anxiety Depression Scale
    • Time Frame: 3 weeks, 6 weeks and 1 month after completion of program
    • This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal
  • Respiratory function test
    • Time Frame: 3 weeks, 6 weeks and 1 month after completion of program
    • It is a test of respiratory function
  • 6-minute walk distance
    • Time Frame: 3 weeks and 1 month after completion of program
    • It is the maximum distance walked in 6 minutes

Participating in This Clinical Trial

Inclusion Criteria

1. Age 21 years and above 2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7 3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis 4. Fit to participate in exercise therapy as determined by both physician and physiotherapist 5. Has the mental capacity to follow instructions 6. Experience shortness of breath on exertion 7. Have decreased ability to carry out activities due to shortness of breath 8. Willing to participate in the exercise program Exclusion Criteria:

1. Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe 2. Pulmonary disorder other than COPD 3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Changi General Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yingjuan Mok, MBBS, Principal Investigator, Changi General Hospital
  • Overall Contact(s)
    • Yingjuan Mok, MBS, 68502600, mok.yingjuan@singhealth.com.sg

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