Back to resultsHigh Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Usual care
High flow nasal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Age 21 years and above
- Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7
- Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
- Fit to participate in exercise therapy as determined by both physician and physiotherapist
- Has the mental capacity to follow instructions
- Experience shortness of breath on exertion
- Have decreased ability to carry out activities due to shortness of breath
- Willing to participate in the exercise program
Exclusion Criteria:
- Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
- Pulmonary disorder other than COPD
- Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
Sites / Locations
- Changi General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
High flow nasal oxygen
Arm Description
Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
Patients will undergo pulmonary rehabilitation with high flow nasal oxygen
Outcomes
Primary Outcome Measures
6-minute walk distance
It is the maximum distance walked in 6 minutes
Secondary Outcome Measures
COPD Assessment Test score
Chronic obstructive pulmonary disease assessment test (CAT) score
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
Respiratory function test
It is a test of respiratory function
6-minute walk distance
It is the maximum distance walked in 6 minutes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03940040
Brief Title
High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
Arm Title
High flow nasal oxygen
Arm Type
Experimental
Arm Description
Patients will undergo pulmonary rehabilitation with high flow nasal oxygen
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual Care
Intervention Type
Other
Intervention Name(s)
High flow nasal oxygen
Intervention Description
High flow nasal oxygen
Primary Outcome Measure Information:
Title
6-minute walk distance
Description
It is the maximum distance walked in 6 minutes
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
COPD Assessment Test score
Description
Chronic obstructive pulmonary disease assessment test (CAT) score
Time Frame
3 weeks, 6 weeks and 1 month after completion of program
Title
Hospital Anxiety Depression Scale
Description
This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal
Time Frame
3 weeks, 6 weeks and 1 month after completion of program
Title
Respiratory function test
Description
It is a test of respiratory function
Time Frame
3 weeks, 6 weeks and 1 month after completion of program
Title
6-minute walk distance
Description
It is the maximum distance walked in 6 minutes
Time Frame
3 weeks and 1 month after completion of program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 21 years and above
Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7
Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
Fit to participate in exercise therapy as determined by both physician and physiotherapist
Has the mental capacity to follow instructions
Experience shortness of breath on exertion
Have decreased ability to carry out activities due to shortness of breath
Willing to participate in the exercise program
Exclusion Criteria:
Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
Pulmonary disorder other than COPD
Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjuan Mok, MBS
Phone
68502600
Email
mok.yingjuan@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Shameerah Abdul Halim
Phone
68502600
Email
Nur_Shameerah@cgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingjuan Mok, MBBS
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjuan Mok, MBBS
Phone
68502600
Email
mok.yingjuan@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Nur Shameerah Abdul Halim
Phone
68502600
Email
Nur_Shameerah@cgh.com.sg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
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