High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940040
• Other study ID #: HFO_RCT
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: June 2021

Study information

• Verified date: October 2020
• Source: Changi General Hospital
• Contact: Yingjuan Mok, MBS
• Phone: 68502600
• Email: mok.yingjuan[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk distance	It is the maximum distance walked in 6 minutes	6 weeks
Secondary	COPD Assessment Test score	Chronic obstructive pulmonary disease assessment test (CAT) score	3 weeks, 6 weeks and 1 month after completion of program
Secondary	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
Secondary	Respiratory function test	It is a test of respiratory function	3 weeks, 6 weeks and 1 month after completion of program
Secondary	6-minute walk distance	It is the maximum distance walked in 6 minutes	3 weeks and 1 month after completion of program