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.

The primary aim of this pilot randomized controlled trial is to determine feasibility of the proposed pulmonary rehabilitation intervention.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Rehabilitation
• Intervention / Treatment: Device: High flow oxygen; Other: Usual care

Detailed Description

In this pilot randomized controlled trial, our primary aim is to determine feasibility of the proposed intervention.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingjuan Mok, MBBS; Phone Number: 69366603; Email: mok.yingjuan@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Yingjuan Mok, MBBS; Phone Number: 69366603; Email: mok.yingjuan@singhealth.com.sg
    • Contact: Yajie Zhang; Phone Number: 64267825; Email: Yajie_Zhang@cgh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow oxygen; High flow nasal oxygen	Device: High flow oxygen; Use of HFO
Active Comparator: Usual care; room air or normal flow oxygen	Other: Usual care; Room air or normal flow oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in 1-minute sit to stand test	maximum number of sit to stand cycles in 1 minute	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in 30-second sit to stand test	maximum number of sit to stand cycles in 30 seconds	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	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.	1 month, 3 month
changes in quality of life	EQ-5D-5L	1 month, 3 month
Changes in lung function	Forced expiratory volume in 1 sec	1 month, 3 month
Changes in lung function	forced vital capacity	1 month, 3 month
Proportion of patients who still have exertional hypoxemia	Comparing the proportion of patients who still have exertional hypoxemia	1 month, 3 month
Adherence rates	Comparing the adherence rates between the 2 study arms	3 week
Changes in 1-minute sit to stand test	maximum number of sit to stand cycles in 1 minute	3 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview	Qualitative interviews will also be conducted to obtain patient perspectives of the interventions in the study	Upon completion of study, or when patients end participation in the study

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Investigators: Principal Investigator: Yingjuan Mok, Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2022/2605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No