Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000612415
Ethics application status
Approved
Date submitted
27/11/2007
Date registered
28/11/2007
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an exercise program on function, activity and participation of young people with cystic fibrosis
Scientific title
Effect of a targeted exercise program versus current exercise practice on function, activity and participation of young people with cystic fibrosis: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 2592 0
Condition category
Condition code
Human Genetics and Inherited Disorders 2702 2702 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 2703 2703 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group receive usual inpatient treatment, including medical, nutritional and physiotherapy. In place of the usual physiotherapy exercise program, participants in this group receive a targeted exercise program, addressing components of strength, flexibility and aerobic and anaerobic activities. This supervised program is performed five days per week (for up to 60 minutes), and is encouraged to be continued over the weekend (supervised by parent / guardian). Participants receive an exercise pack which includes items to encourage physical activity. A log is used for documentation of activities and relevant measures (for example: heart rate, breathlessness score, shuttle level attained or number of jumps performed in 30 seconds etc). A pedometer is provided to count the number of steps taken during the session and between sessions. Prior to discharge from hospital, advice is given regarding continuation of the program at home, aiming for 30 minutes on three days per week. This program is continued for 12 weeks following discharge. Strategies to encourage adherence to the home program include contact via telephone and email.
Intervention code [1] 2324 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group receive usual inpatient treatment including medical, nutritional and physiotherapy. Participants receive the usual practice exercise program as part of the physiotherapy airway clearance regimen. This supervised program includes general aerobic-type activity, performed five days per week (for up to 60 minutes). Detail of session duration and activities performed is documented by the treating therapist on a study form. Following discharge from hospital, participants perform usual physical activity.
Control group
Active

Outcomes
Primary outcome [1] 3603 0
Six Minute Walk Test (distance). Measures of breathlessness (Borg Scale of Perceived Breathlessness and the Fifteen Count Breathlessness Score) are taken at baseline and completion of the walk test. Physiological variables (heart rate and oxygen saturation) are taken at baseline and monitored throughout the walk test via pulse oximetry.
Timepoint [1] 3603 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [1] 6029 0
Range of motion of the thoracolumbar, upper limbs and lower limbs.
Timepoint [1] 6029 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [2] 6030 0
Isometric muscle force using a La Fayette portable handheld dynamometer, for six muscle groups on the non-dominant side.
Timepoint [2] 6030 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [3] 6031 0
Muscle power of the upper limbs (seated ball throw) and lower limbs (vertical jump height).
Timepoint [3] 6031 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [4] 6032 0
Functional capacity using two jump tasks (astride jumps and forwards-backwards jumps). Measures of breathlessness (Borg Scale of Perceived Breathlessness and the Fifteen Count Breathlessness Score) are taken at baseline and completion of each jump task. Physiological variables (heart rate and oxygen saturation) are taken at baseline and monitored throughout the jump tasks via pulse-oximetry.
Timepoint [4] 6032 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [5] 6033 0
Quality of life using the Cystic Fibrosis Questionnaire - revised version (CFQr).
Timepoint [5] 6033 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.
Secondary outcome [6] 6034 0
Activity levels and participation in physical activity using the Fels Physical Activity Questionnaire for Children, and the Three Day Activity Diary.
Timepoint [6] 6034 0
These measures are completed once during the 14 day inpatient period, and once during the 12 week outpatient period.
Secondary outcome [7] 6035 0
Respiratory function (namely Forced Expiratory Volume in one second), tested by a trained respiratory function technician.
Timepoint [7] 6035 0
All measures are taken at three timepoints: admission to hospital, prior to discharge from hospital (14 days from admission) and twelve weeks post discharge.

Eligibility
Key inclusion criteria
Diagnosis of Cystic Fibrosis; Hospitalised due to acute exacerbation of respiratory symptoms; Cognitively and physically able to perform the study tasks.
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal impairments (present or in the twelve months preceding testing).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2007
Actual
2/04/2007
Date of last participant enrolment
Anticipated
Actual
31/01/2008
Date of last data collection
Anticipated
Actual
30/04/2008
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 502 0
4029

Funding & Sponsors
Funding source category [1] 2835 0
University
Name [1] 2835 0
The University of Queensland (Australian Postgraduate Award)
Country [1] 2835 0
Australia
Primary sponsor type
Individual
Name
Allison Mandrusiak
Address
School of Health and Rehabilitation Sciences
Division of Physiotherapy
The University of Queensland
St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 2558 0
None
Name [1] 2558 0
Address [1] 2558 0
Country [1] 2558 0
Other collaborator category [1] 96 0
Individual
Name [1] 96 0
Dr Pauline Watter
Address [1] 96 0
School of Health and Rehabilitation Sciences
Division of Physiotherapy
The University of Queensland
St Lucia, Qld 4072
Country [1] 96 0
Australia
Other collaborator category [2] 97 0
Individual
Name [2] 97 0
Christine Wilson
Address [2] 97 0
Physiotherapy Department
Royal Children's Hospital
Herston Road
Herston, Qld 4029
Country [2] 97 0
Australia
Other collaborator category [3] 98 0
Individual
Name [3] 98 0
Dr Jennifer Paratz
Address [3] 98 0
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, Qld 4029
Country [3] 98 0
Australia
Other collaborator category [4] 99 0
Individual
Name [4] 99 0
Julie MacDonald
Address [4] 99 0
School of Health and Rehabilitation Sciences
Division of Physiotherapy
The University of Queensland
St Lucia, Qld 4072
Country [4] 99 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4766 0
Medical Research Ethics Committee (The University of Queensland)
Ethics committee address [1] 4766 0
Ethics committee country [1] 4766 0
Australia
Date submitted for ethics approval [1] 4766 0
Approval date [1] 4766 0
15/11/2006
Ethics approval number [1] 4766 0
2006 000 352
Ethics committee name [2] 4767 0
Royal Children's Hospital Ethics Committee
Ethics committee address [2] 4767 0
Ethics committee country [2] 4767 0
Australia
Date submitted for ethics approval [2] 4767 0
Approval date [2] 4767 0
25/10/2006
Ethics approval number [2] 4767 0
2006 043

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

Contacts
Principal investigator
Name 28217 0
Address 28217 0
Country 28217 0
Phone 28217 0
Fax 28217 0
Email 28217 0
Contact person for public queries
Name 11374 0
Allison Mandrusiak
Address 11374 0
School of Health and Rehabilitation Sciences
Division of Physiotherapy
The University of Queensland
St Lucia, Qld 4072
Country 11374 0
Australia
Phone 11374 0
(07) 3365 4591
Fax 11374 0
Email 11374 0
[email protected]
Contact person for scientific queries
Name 2302 0
Allison Mandrusiak
Address 2302 0
School of Health and Rehabilitation Sciences
Division of Physiotherapy
The University of Queensland
St Lucia, Qld 4072
Country 2302 0
Australia
Phone 2302 0
(07) 3365 4591
Fax 2302 0
Email 2302 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.