Improving Outcomes of Respiratory Patients With Exertional Hypoxemia

Pulmonary Rehabilitation Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752370
• Other study ID #: 2022/2605
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: Changi General Hospital
• Contact: Yingjuan Mok, MBBS
• Phone: 69366603
• Email: mok.yingjuan[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Pulmonary Rehabilitation

Intervention

Device:
• High flow oxygen
Use of HFO

Other:
• Usual care
Room air or normal flow oxygen

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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