Pulmonary RehabilitationNCT05752370
Improving Outcomes of Respiratory Patients With Exertional Hypoxemia
A study testing High flow oxygen in people with Pulmonary Rehabilitation, run by Changi General Hospital at 1 site in Singapore.
Trial summary
The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Pulmonary Rehabilitation
- What is being tested?
- High flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Mar 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- uncontrolled severe medical conditions
- currently enrolled in a pulmonary rehabilitation trial
- unsuitable for randomization as determined by the patient's physician
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Yingjuan Mok, MBBS, 69366603, mok.yingjuan@singhealth.com.sg
Yajie Zhang, 64267825, Yajie_Zhang@cgh.com.sg
About this study
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.
The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.
Read the detailed description
In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.
- Conditions
- Pulmonary Rehabilitation
- Being tested
- High flow oxygen, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygenDevice
Use of HFO
Usual careOther
Room air or normal flow oxygen
| Study group | Role | What they receive |
|---|---|---|
| High flow oxygen | Experimental | High flow nasal oxygen Receives: Device: High flow oxygen |
| Usual care | Active comparator | room air or normal flow oxygen Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 1-minute sit to stand test
maximum number of sit to stand cycles in 1 minute
Measured: 1 month
Secondary outcomes (9)
Changes in 30-second sit to stand test
maximum number of sit to stand cycles in 30 seconds
Measured: 1 month, 3 month
Changes in respiratory symptoms
Modified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness
Measured: 1 month, 3 months
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.
Measured: 1 month, 3 month
changes in quality of life
EQ-5D-5L
Measured: 1 month, 3 month
Changes in lung function
Forced expiratory volume in 1 sec
Measured: 1 month, 3 month
Changes in lung function
forced vital capacity
Measured: 1 month, 3 month
Proportion of patients who still have exertional hypoxemia
Comparing the proportion of patients who still have exertional hypoxemia
Measured: 1 month, 3 month
Adherence rates
Comparing the adherence rates between the 2 study arms
Measured: 3 week
Changes in 1-minute sit to stand test
maximum number of sit to stand cycles in 1 minute
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start5 Mar 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingjuan Mok, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752370
- Sponsor's protocol ID
- 2022/2605
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mok Y, Foong JW, Wong HS, Shih-Yen EC, Hassan N, Klainin-Yobas P, Soh LC, Soh A, Tan SH, Koh XH, Tan PC, Wong KKH. High-Flow Nasal Oxygen in Early Home Pulmonary Rehabilitation for Exertional Hypoxaemia: A Pilot Randomised Feasibility Trial. Respirology. 2026 Jul 3. doi: 10.1002/resp.70277. Online ahead of print.
PubMed 42397015
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05752370
- Acronym / sponsor ID
- 2022/2605
- Conditions
- Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen | Experimental | Device: High flow oxygenHigh flow nasal oxygen |
| Usual care | Active comparator | Other: Usual careroom air or normal flow oxygen |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- uncontrolled severe medical conditions
- currently enrolled in a pulmonary rehabilitation trial
- unsuitable for randomization as determined by the patient's physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygenUse of HFO | Device | High flow oxygen |
| Usual careRoom air or normal flow oxygen | Other | Usual care |
Primary outcome
Changes in 1-minute sit to stand test
Time frame: 1 month
maximum number of sit to stand cycles in 1 minute
9 secondary outcomes
Changes in 30-second sit to stand test
Time frame: 1 month, 3 month
Changes in respiratory symptoms
Time frame: 1 month, 3 months
Changes in mood
Time frame: 1 month, 3 month
changes in quality of life
Time frame: 1 month, 3 month
Changes in lung function
Time frame: 1 month, 3 month
Changes in lung function
Time frame: 1 month, 3 month
Proportion of patients who still have exertional hypoxemia
Time frame: 1 month, 3 month
Adherence rates
Time frame: 3 week
Changes in 1-minute sit to stand test
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 42397015Mok Y, Foong JW, Wong HS, Shih-Yen EC, Hassan N, Klainin-Yobas P, Soh LC, Soh A, Tan SH, Koh XH, Tan PC, Wong KKH. High-Flow Nasal Oxygen in Early Home Pulmonary Rehabilitation for Exertional Hypoxaemia: A Pilot Randomised Feasibility Trial. Respirology. 2026 Jul 3. doi: 10.1002/resp.70277. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingjuan Mok principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen in people with Pulmonary Rehabilitation, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingjuan Mok, MBBS (69366603, mok.yingjuan@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 1-minute sit to stand test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.