Improving Outcomes of Respiratory Patients With Exertional Hypoxemia

Not Applicable

Recruiting

• Conditions: Pulmonary Rehabilitation
• Interventions: Device: High flow oxygen; Other: Usual care

• Registration Number: NCT05752370
• Lead Sponsor: Changi General Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-02
• Study Start: 2023-03-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow oxygen	High flow oxygen	High flow nasal oxygen
Usual care	Usual care	room air or normal flow oxygen

Primary Outcome Measures

Name	Time	Method
Changes in 1-minute sit to stand test	1 month	maximum number of sit to stand cycles in 1 minute

Secondary Outcome Measures

Name	Time	Method
Changes in 30-second sit to stand test	1 month, 3 month	maximum number of sit to stand cycles in 30 seconds
Changes in respiratory symptoms	1 month, 3 months	Modified Medical Research Council Dyspnea Scale. The scale ranges from 0 to 4 with a higher score indicating increasing breathlessness
Changes in mood	1 month, 3 month	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 lung function	1 month, 3 month	forced vital capacity
Proportion of patients who still have exertional hypoxemia	1 month, 3 month	Comparing the proportion of patients who still have exertional hypoxemia
Adherence rates	3 week	Comparing the adherence rates between the 2 study arms
Changes in 1-minute sit to stand test	3 month	maximum number of sit to stand cycles in 1 minute
changes in quality of life	1 month, 3 month	EQ-5D-5L

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore