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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
Changi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Rehabilitation

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 13, 2023
Last Updated
September 22, 2023
Sponsor
Changi General Hospital
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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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