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Trial registered on ANZCTR


Registration number
ACTRN12611000160932
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
10/02/2011
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
19/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of life, days in hospital, lung function and fitness before and after attending the outpatient cystic fibrosis (CF) physiotherapy service
Scientific title
Children and adolescents with cystic fibrosis attending the Women's and Children's Hospital Ambulatory Cystic Fibrosis Physiotherapy Clinic - effect on quality of life, number of occupied bed days, pulmonary function and exercise capacity.
Secondary ID [1] 253456 0
nil
Universal Trial Number (UTN)
U1111-1119-1890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 261009 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259144 259144 0 0
Physiotherapy
Respiratory 259287 259287 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will attend up to 52 (depending on need and assessed on a case by case basis) 1-1.5 hour weekly outpatient appointments with a physiotherapist who will work with the patient and family to optimise and individualise the patients airway clearance techniques including positive expiratory pressure, inhalation techinques, postural drainage, and autogenic drainage. During the outpatient sessions, patients will participate in physical activity including aerobic and anaerobic activities. Principles of chronic condition self management will be engaged to increase patient participation and treatment adherence.
Intervention code [1] 257898 0
Lifestyle
Intervention code [2] 257903 0
Treatment: Other
Comparator / control treatment
Before and after baseline data for each patient will be used ie 2010 compared to 2011
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262000 0
Number of admissions and occupied bed days. Information generated by the Women's and Children's Hospital HIPPO (Health Informatics, Performance, Planning and Outcomes) Unit
Timepoint [1] 262000 0
Number of admssions and occupied bed days in 2010 and 2011
Primary outcome [2] 262001 0
Quality of life score using the CFQ-R (Cystic Fibrosis Questionnaire - Revised
Timepoint [2] 262001 0
At commencement of clinic participation (January 2010) and at the end of 2011 (Decemeber 2011)
Primary outcome [3] 262002 0
Pulmonary function, best FVC, FEV1 and MMEF using standard spirometry.
Timepoint [3] 262002 0
Best for 2010 and 2011
Secondary outcome [1] 268932 0
Exercise capacity determined by distance travelled on the modified shuttle walk test and VO2max
Timepoint [1] 268932 0
At commencement of clinic participation (January 2010) and at the end of 2011 (Decemeber 2011)

Eligibility
Key inclusion criteria
Patients with cystic fibrosis who have had 3 or more respiratory related admissions to the Women's and Children's Hospital in 2010/2011.
Minimum age
0 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not consent to participating in the Ambulatory CF Physiotherapy clinic

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



Intervention assignment
Single group
Other design features
nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
paired t-test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 258377 0
Government body
Name [1] 258377 0
GP Plus
Address [1] 258377 0
c/o SA Health
PO Box 287 Rundle Mall
Adelaide SA 5000
Country [1] 258377 0
Australia
Primary sponsor type
Individual
Name
Angela Potter
Address
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Country
Australia
Secondary sponsor category [1] 257523 0
Individual
Name [1] 257523 0
Phil Calvert
Address [1] 257523 0
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Country [1] 257523 0
Australia
Other collaborator category [1] 251782 0
Individual
Name [1] 251782 0
Jodie-Ann Hochuli
Address [1] 251782 0
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Country [1] 251782 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260354 0
Children, Youth and Women's Health Service Human Research Ethics Committee
Ethics committee address [1] 260354 0
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Ethics committee country [1] 260354 0
Australia
Date submitted for ethics approval [1] 260354 0
Approval date [1] 260354 0
17/12/2010
Ethics approval number [1] 260354 0
REC2342/12/13

Summary
Brief summary
To determine the effect of participation in the new Ambulatory CF Physiotherapy Clinic on patients' quality of life, lung function, fitness and number of days in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32122 0
Mr Wee-Ren Kong
Address 32122 0
72 King William St, North Adelaide, SA, 5006
Women's and Children's Hospital
Country 32122 0
Australia
Phone 32122 0
+61 8 81617381
Fax 32122 0
+618 81617040
Email 32122 0
weeren.kong@sa.gov.au
Contact person for public queries
Name 15369 0
Miss Angela Potter
Address 15369 0
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Country 15369 0
Australia
Phone 15369 0
61 8 8161 7381
Fax 15369 0
61 8 8161 7040
Email 15369 0
angela.potter@health.sa.gov.au
Contact person for scientific queries
Name 6297 0
Miss Angela Potter
Address 6297 0
Women's and Children's Hospital
72 King William St
North Adelaide 5006
South Australia
Country 6297 0
Australia
Phone 6297 0
61 8 8161 7381
Fax 6297 0
61 8 8161 7040
Email 6297 0
angela.potter@health.sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 3251 0
Conference abstract
Citation/DOI/link/details [1] 3251 0
Kong W and Potter A. Ambulatory Physiotherapy: Improving Outcomes for Children with Declining Health. Pediatric Pulmonology (2011) 46 S34 pg 355.
Results – basic reporting
Results – plain English summary