High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

NCT ID: NCT03940040

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2021-06-30

Brief Summary

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To compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Detailed Description

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This is a pilot randomized controlled trial to compare the effects of high flow nasal oxygen with usual care during an outpatient 6-week pulmonary rehabilitation program after hospitalization for COPD exacerbation.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual Care

High flow nasal oxygen

Patients will undergo pulmonary rehabilitation with high flow nasal oxygen

Group Type EXPERIMENTAL

High flow nasal oxygen

Intervention Type OTHER

High flow nasal oxygen

Interventions

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Usual care

Usual Care

Intervention Type OTHER

High flow nasal oxygen

High flow nasal oxygen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 21 years and above
2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio \<0.7
3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis
4. Fit to participate in exercise therapy as determined by both physician and physiotherapist
5. Has the mental capacity to follow instructions
6. Experience shortness of breath on exertion
7. Have decreased ability to carry out activities due to shortness of breath
8. Willing to participate in the exercise program

Exclusion Criteria

1. Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe
2. Pulmonary disorder other than COPD
3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingjuan Mok, MBBS

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Yingjuan Mok, MBS

Role: CONTACT

Nur Shameerah Abdul Halim

Role: CONTACT

Facility Contacts

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Yingjuan Mok, MBBS

Role: primary

Nur Shameerah Abdul Halim

Role: backup

Other Identifiers

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HFO_RCT

Identifier Type: -

Identifier Source: org_study_id

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