Improving Outcomes of Respiratory Patients With Exertional Hypoxemia
Primary Purpose
Pulmonary Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
High flow oxygen
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Rehabilitation
Eligibility Criteria
Inclusion Criteria: 21 years and above Presence of exertional hypoxemia during 1-minute sit-to-stand test diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist Exclusion Criteria: uncontrolled severe medical conditions currently enrolled in a pulmonary rehabilitation trial unsuitable for randomization as determined by the patient's physician
Sites / Locations
- Changi General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High flow oxygen
Usual care
Arm Description
High flow nasal oxygen
room air or normal flow oxygen
Outcomes
Primary Outcome Measures
Changes in 1-minute sit to stand test
maximum number of sit to stand cycles in 1 minute
Secondary Outcome Measures
Changes in 30-second sit to stand test
maximum number of sit to stand cycles in 30 seconds
Changes in respiratory symptoms
Modified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness
Changes in mood
Hospital Anxiety Depression Scale. The scale ranges from 0 to 21, A total subscale score of >8 points indicates considerable symptoms of anxiety or depression.
changes in quality of life
EQ-5D-5L
Changes in lung function
Forced expiratory volume in 1 sec
Changes in lung function
forced vital capacity
Proportion of patients who still have exertional hypoxemia
Comparing the proportion of patients who still have exertional hypoxemia
Adherence rates
Comparing the adherence rates between the 2 study arms
Changes in 1-minute sit to stand test
maximum number of sit to stand cycles in 1 minute
Full Information
NCT ID
NCT05752370
First Posted
February 13, 2023
Last Updated
September 22, 2023
Sponsor
Changi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05752370
Brief Title
Improving Outcomes of Respiratory Patients With Exertional Hypoxemia
Official Title
Improving Post-hospitalization Outcomes of Respiratory Patients With Exertional Hypoxemia by Early Pulmonary Rehabilitation Using High Flow Nasal Oxygen- a Pilot Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (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
5. Study Description
Brief Summary
The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.
Detailed Description
In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High flow oxygen
Arm Type
Experimental
Arm Description
High flow nasal oxygen
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
room air or normal flow oxygen
Intervention Type
Device
Intervention Name(s)
High flow oxygen
Intervention Description
Use of HFO
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Room air or normal flow oxygen
Primary Outcome Measure Information:
Title
Changes in 1-minute sit to stand test
Description
maximum number of sit to stand cycles in 1 minute
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes in 30-second sit to stand test
Description
maximum number of sit to stand cycles in 30 seconds
Time Frame
1 month, 3 month
Title
Changes in respiratory symptoms
Description
Modified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness
Time Frame
1 month, 3 months
Title
Changes in mood
Description
Hospital Anxiety Depression Scale. The scale ranges from 0 to 21, A total subscale score of >8 points indicates considerable symptoms of anxiety or depression.
Time Frame
1 month, 3 month
Title
changes in quality of life
Description
EQ-5D-5L
Time Frame
1 month, 3 month
Title
Changes in lung function
Description
Forced expiratory volume in 1 sec
Time Frame
1 month, 3 month
Title
Changes in lung function
Description
forced vital capacity
Time Frame
1 month, 3 month
Title
Proportion of patients who still have exertional hypoxemia
Description
Comparing the proportion of patients who still have exertional hypoxemia
Time Frame
1 month, 3 month
Title
Adherence rates
Description
Comparing the adherence rates between the 2 study arms
Time Frame
3 week
Title
Changes in 1-minute sit to stand test
Description
maximum number of sit to stand cycles in 1 minute
Time Frame
3 month
Other Pre-specified Outcome Measures:
Title
Qualitative interview
Description
Qualitative interviews will also be conducted to obtain patient perspectives of the interventions in the study
Time Frame
Upon completion of study, or when patients end participation in the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
21 years and above
Presence of exertional hypoxemia during 1-minute sit-to-stand test
diagnosis of acute COPD exacerbation or Covid-19 pneumonia or exacerbation of bronchiectasis or exacerbation of interstitial lung disease
physically fit to participate in exercise therapy as determined by both the patient's physician and physiotherapist
Exclusion Criteria:
uncontrolled severe medical conditions
currently enrolled in a pulmonary rehabilitation trial
unsuitable for randomization as determined by the patient's physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjuan Mok, MBBS
Phone
69366603
Email
mok.yingjuan@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingjuan Mok
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
69366603
Email
mok.yingjuan@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Yajie Zhang
Phone
64267825
Email
Yajie_Zhang@cgh.com.sg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Outcomes of Respiratory Patients With Exertional Hypoxemia
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