High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Usual care; Other: High flow nasal oxygen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Nur Shameerah Abdul Halim; Phone Number: 68502600; Email: Nur_Shameerah@cgh.com.sg
    • Contact: Yingjuan Mok, MBBS; Phone Number: 68502600; Email: mok.yingjuan@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)	Other: Usual care; Usual Care
Experimental: High flow nasal oxygen; Patients will undergo pulmonary rehabilitation with high flow nasal oxygen	Other: High flow nasal oxygen; High flow nasal oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk distance	It is the maximum distance walked in 6 minutes	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: May 5, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HFO_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No