High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Usual care; Other: High flow nasal oxygen

• Registration Number: NCT03940040
• Lead Sponsor: Changi General Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-07
• Study Start: 2019-05-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual care	Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
High flow nasal oxygen	High flow nasal oxygen	Patients will undergo pulmonary rehabilitation with high flow nasal oxygen

Primary Outcome Measures

Name	Time	Method
6-minute walk distance	6 weeks	It is the maximum distance walked in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety Depression Scale	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
COPD Assessment Test score	3 weeks, 6 weeks and 1 month after completion of program	Chronic obstructive pulmonary disease assessment test (CAT) score
Respiratory function test	3 weeks, 6 weeks and 1 month after completion of program	It is a test of respiratory function
6-minute walk distance	3 weeks and 1 month after completion of program	It is the maximum distance walked in 6 minutes

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore