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Improving Outcomes of Respiratory Patients With Exertional Hypoxemia

Improving Post-hospitalization Outcomes of Respiratory Patients With Exertional Hypoxemia by Early Pulmonary Rehabilitation Using High Flow Nasal Oxygen- a Pilot Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05752370
Enrollment
56
Registered
2023-03-02
Start date
2023-03-05
Completion date
2024-11-30
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Rehabilitation

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.

Interventions

Use of HFO

OTHERUsual care

Room air or normal flow oxygen

Sponsors

Changi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in 1-minute sit to stand test1 monthmaximum number of sit to stand cycles in 1 minute

Secondary

MeasureTime frameDescription
Changes in 30-second sit to stand test1 month, 3 monthmaximum number of sit to stand cycles in 30 seconds
Changes in respiratory symptoms1 month, 3 monthsModified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness
Changes in mood1 month, 3 monthHospital 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 life1 month, 3 monthEQ-5D-5L
Proportion of patients who still have exertional hypoxemia1 month, 3 monthComparing the proportion of patients who still have exertional hypoxemia
Adherence rates3 weekComparing the adherence rates between the 2 study arms
Changes in 1-minute sit to stand test3 monthmaximum number of sit to stand cycles in 1 minute
Changes in lung function1 month, 3 monthForced expiratory volume in 1 sec

Other

MeasureTime frameDescription
Qualitative interviewUpon completion of study, or when patients end participation in the studyQualitative interviews will also be conducted to obtain patient perspectives of the interventions in the study

Countries

Singapore

Contacts

Primary ContactYingjuan Mok, MBBS
mok.yingjuan@singhealth.com.sg69366603

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026