Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000236796
Ethics application status
Approved
Date submitted
16/01/2022
Date registered
10/02/2022
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the effectiveness of a comprehensive Chinese language based introductory pulmonary rehabilitation program for individuals with pulmonary disease in Australia
Scientific title
A pilot study of the effectiveness of a comprehensive Chinese language based introductory pulmonary rehabilitation program for individuals with pulmonary disease in Australia
Secondary ID [1] 306219 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 324937 0
interstitial lung disease 324938 0
lung cancer 324939 0
Bronchiectasis 324940 0
Asthma 324941 0
Condition category
Condition code
Respiratory 322366 322366 0 0
Chronic obstructive pulmonary disease
Respiratory 322367 322367 0 0
Asthma
Respiratory 322368 322368 0 0
Other respiratory disorders / diseases
Cancer 322369 322369 0 0
Lung - Non small cell
Cancer 322370 322370 0 0
Lung - Small cell
Cancer 322371 322371 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary rehabilitation is a standard of care for patients with chronic obstructive pulmonary disease and other chronic lung diseases. The program duration totals 8 weeks, with 2 classes per week. Each class duration is 1 hour, overseen by a physiotherapist and respiratory physician who are fluent in Cantonese and Mandarin written and spoken language. Pulmonary rehabilitation involves exercises and education to improve lung function, symptoms and functional status. In details, the class program includes:
1st session: 15mins information, then 30 minutes of pulmonary rehabilitation exercises, followed with 15mins education on lifestyle changes to improve lung function
2nd visit onwards, measurement of blood pressure and oxygen levels before exercise. Followed by 45mins exercise, and then 15mins education. Modifications if needed on a case-to-case basis.
The class is performed as face-face at a rehabilitation gym, with group of no more than eight.
No physical informational/educational materials will be provided to participants, but participants will be provided information and weblink to Lung Foundation Australia (https://lungfoundation.com.au).
The exercises that are prescribed are: treadmill, bike, sit to stand + walk, step-ups, upper body dumbells/therabands, upper body cable machine. If the participant is unable to perform the exercise, it will be modified to suit their condition or limitations.
Participant attendance is taken every session. If there are any problems reported by participants, they will be referred back up to specialists for review.


Intervention code [1] 322621 0
Treatment: Other
Intervention code [2] 322682 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330135 0
Effectiveness of pulmonary rehabilitation class in Chinese language for non-English speaking Chinese patients. This will be assessed by comparing objective physiological measures: forced expiratory volume in 1 second (FEV1) determined by spirometry
Timepoint [1] 330135 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.
Primary outcome [2] 330256 0
Objective physiological measures: Forced Vital Capacity (FVC) determined by spirometry
Timepoint [2] 330256 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.
Primary outcome [3] 330257 0
Objective physiological measures: Diffusing capacity for carbon monoxide (DLCO) determined by single-breath ten-second breath-hold technique of gas mixture containing 0.3 percent carbon monoxide.
Timepoint [3] 330257 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.
Secondary outcome [1] 404998 0
Oxygen saturation assessed using a pulse oximeter (SaO2) as Primary Outcome
Timepoint [1] 404998 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.
Secondary outcome [2] 405484 0
Aerobic capacity assessed as distance walked during a 6-minute walk test as Primary Outcome
Timepoint [2] 405484 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.
Secondary outcome [3] 405485 0
A standardized quality of life questionnaire, the St. George Respiratory Questionnaire,
Timepoint [3] 405485 0
Before commencement of pulmonary rehabilitation class, and at completion of the 8-weeks class program.

Eligibility
Key inclusion criteria
- Age > 50
- Both sexes included
- Presence of a pulmonary disorder that may benefit from pulmonary rehabilitation
- Intact cognition, able to follow instructions of the program
- Level of English not proficient enough to partake in English based classes
- Independently mobile (can use walking aids)
Minimum age
51 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unstable cardiovascular disease precluding pulmonary rehabilitation
- Significant heart failure
- Unstable psychiatric disorder
- Current acute illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intended sample size is 96 patients. This is above the current average literature figures. A Cochrane study of
the effects of pulmonary rehabilitation in patients with COPD examined 38 studies which reported 6 minute-walk test with a total of 1879 patients, approx. 49 patients per study, with a detected mean difference of 43m. We aim to detect a difference of 30m and the required sample size is 36 patients. This was derived from G*Power software (version 3.1.9.2) using paired t tests to detect the difference in means between 2 dependent means (matched pairs) with an alpha of 0.05, power 0.8, and standard deviation of results from previous retrospective data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2020
Date of last participant enrolment
Anticipated
Actual
1/11/2021
Date of last data collection
Anticipated
Actual
24/12/2021
Sample size
Target
96
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21485 0
Hurstville Private - Hurstville
Recruitment hospital [2] 21486 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 36392 0
2220 - Hurstville
Recruitment postcode(s) [2] 36393 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 310568 0
Commercial sector/Industry
Name [1] 310568 0
AstraZeneca
Country [1] 310568 0
Australia
Primary sponsor type
University
Name
University of New South Wales, St George and Sutherland Hospital Campus
Address
Clinical Sciences (WRPitney) Building, Short Street, St George Hospital, Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 311743 0
Hospital
Name [1] 311743 0
Hurstville Private Hospital
Address [1] 311743 0
37 Gloucester Rd, Hurstville NSW 2220
Country [1] 311743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310175 0
University of New South Wales (UNSW) Medicine HREC committee A
Ethics committee address [1] 310175 0
Ethics committee country [1] 310175 0
Australia
Date submitted for ethics approval [1] 310175 0
05/08/2018
Approval date [1] 310175 0
08/04/2019
Ethics approval number [1] 310175 0
HC180824

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116754 0
A/Prof Benjamin Kwan
Address 116754 0
Department of Respiratory and Sleep Medicine, The Sutherland Hospital
The Kingsway, Caringbah
NSW 2229
Country 116754 0
Australia
Phone 116754 0
+61422136690
Fax 116754 0
+61295704855
Email 116754 0
[email protected]
Contact person for public queries
Name 116755 0
Benjamin Kwan
Address 116755 0
Department of Respiratory and Sleep Medicine, The Sutherland Hospital
The Kingsway, Caringbah
NSW 2229
Country 116755 0
Australia
Phone 116755 0
+61295704800
Fax 116755 0
+61295704855
Email 116755 0
[email protected]
Contact person for scientific queries
Name 116756 0
Benjamin Kwan
Address 116756 0
Department of Respiratory and Sleep Medicine, The Sutherland Hospital
The Kingsway, Caringbah
NSW 2229
Country 116756 0
Australia
Phone 116756 0
+61295704800
Fax 116756 0
+61295704855
Email 116756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data or samples shared will be coded and deidentified, this includes all of the individual participant data collected during the trial. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
When will data be available (start and end dates)?
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months
Available to whom?
Data obtained through this study may be provided to qualified researchers with academic interest in chronic lung diseases and pulmonary rehabilitation. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research.
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
All requests should be emailed too principal investigator ([email protected]).
It will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14668Study protocol  [email protected]
14669Informed consent form  [email protected]
14670Clinical study report  [email protected]
14671Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.