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出境医 / 临床实验 / High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Usual care Other: High flow nasal oxygen Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Usual Care
Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
 Other: Usual care
Usual Care
Experimental: High flow nasal oxygen
Patients will undergo pulmonary rehabilitation with high flow nasal oxygen
 Other: High flow nasal oxygen
High flow nasal oxygen
Outcome Measures
Primary Outcome Measures :
  1. 6-minute walk distance [ Time Frame: 6 weeks ]
    It is the maximum distance walked in 6 minutes


Secondary Outcome Measures :
  1. COPD Assessment Test score [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    Chronic obstructive pulmonary disease assessment test (CAT) score

  2. Hospital Anxiety Depression Scale [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal

  3. Respiratory function test [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    It is a test of respiratory function

  4. 6-minute walk distance [ Time Frame: 3 weeks and 1 month after completion of program ]
    It is the maximum distance walked in 6 minutes


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
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Contact: Yingjuan Mok, MBS 68502600 mok.yingjuan@singhealth.com.sg
Contact: Nur Shameerah Abdul Halim 68502600 Nur_Shameerah@cgh.com.sg

Locations
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Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Yingjuan Mok, MBBS    68502600    mok.yingjuan@singhealth.com.sg   
Contact: Nur Shameerah Abdul Halim    68502600    Nur_Shameerah@cgh.com.sg   
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: Yingjuan Mok, MBBS Changi General Hospital
Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019) 		6-minute walk distance [ Time Frame: 6 weeks ]
It is the maximum distance walked in 6 minutes
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		6-minute walk distance [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • COPD Assessment Test score [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    Chronic obstructive pulmonary disease assessment test (CAT) score
  • Hospital Anxiety Depression Scale [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    This scale has 2 subscale scores of 1) Depression 2) Anxiety. Scores of 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal
  • Respiratory function test [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
    It is a test of respiratory function
  • 6-minute walk distance [ Time Frame: 3 weeks and 1 month after completion of program ]
    It is the maximum distance walked in 6 minutes
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • COPD Assessment Test score [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
  • Hospital Anxiety Depression Scale [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
  • Respiratory function test [ Time Frame: 3 weeks, 6 weeks and 1 month after completion of program ]
  • 6-minute walk distance [ Time Frame: 3 weeks and 1 month after completion of program ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation
Official Title  ICMJE Comparing the Effect of High Flow Nasal Oxygen With Usual Care on Pulmonary Rehabilitation in COPD Patients After an Acute Exacerbation; a Pilot Randomized Controlled Trial
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Other: Usual care
    Usual Care
  • Other: High flow nasal oxygen
    High flow nasal oxygen
Study Arms  ICMJE
  • Active Comparator: Usual Care
    Patients will under go usual care ( pulmonary rehabilitation on room air or with nasal oxygen supplementation)
    Intervention: Other: Usual care
  • Experimental: High flow nasal oxygen
    Patients will undergo pulmonary rehabilitation with high flow nasal oxygen
    Intervention: Other: High flow nasal oxygen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2019) 		22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yingjuan Mok, MBS 68502600 mok.yingjuan@singhealth.com.sg
Contact: Nur Shameerah Abdul Halim 68502600 Nur_Shameerah@cgh.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940040
Other Study ID Numbers  ICMJE HFO_RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Changi General Hospital
Study Sponsor  ICMJE Changi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yingjuan Mok, MBBS Changi General Hospital
PRS Account Changi General Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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