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
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started May 2019
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedStudy Start
First participant enrolled
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 8, 2020
October 1, 2020
2 years
May 5, 2019
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
6-minute walk distance
It is the maximum distance walked in 6 minutes
6 weeks
Secondary Outcomes (4)
COPD Assessment Test score
3 weeks, 6 weeks and 1 month after completion of program
Hospital Anxiety Depression Scale
3 weeks, 6 weeks and 1 month after completion of program
Respiratory function test
3 weeks, 6 weeks and 1 month after completion of program
6-minute walk distance
3 weeks and 1 month after completion of program
Study Arms (2)
Usual Care
ACTIVE COMPARATORPatients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
High flow nasal oxygen
EXPERIMENTALPatients will undergo pulmonary rehabilitation with high flow nasal oxygen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changi General Hospital
Singapore, 529889, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingjuan Mok, MBBS
Changi General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2019
First Posted
May 7, 2019
Study Start
May 28, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share