Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000867392
Ethics application status
Approved
Date submitted
23/05/2017
Date registered
13/06/2017
Date last updated
13/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telehealth compared to face to face delivered whole body vibration training in children with Cystic Fibrosis (CF).
Scientific title
Musculoskeletal clinical outcomes of Whole Body Vibration Training as an adjunct to physiotherapy in children with Cystic Fibrosis: a comparison of telehealth and face to face therapy delivery.
Secondary ID [1] 290082 0
NIL
Universal Trial Number (UTN)
U1111-1187-1861
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 300165 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300048 300048 0 0
Physiotherapy
Human Genetics and Inherited Disorders 300049 300049 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
who: 32 pre-pubertal outpatients with CF over 5 years of age (n=16 intervention, n=16 control). Random allocation of subjects will be to home or face-to-face intervention or to the control group.
materials: HYPERVIBE G14 vibration plates will be used in the intervention group (n=16), usual care for controls (n=16). what: intervention- 5 x per week for total 12 week whole body vibration training (WBVT) program consisting of 1 min on: 1 min off intervals for 20mins total working up to 25Hz on the vibration plate in the patients own home. Physio follow up is provided at week 4 and week 8 at home, via telehealth (for 8 patients) or face-to-face at LCCH (8 patients), as dependent on initial random allocation. All controls will perform the initial and 12 week assessments and are provided with usual 3 monthly clinical care.
Intervention code [1] 295817 0
Prevention
Intervention code [2] 295818 0
Rehabilitation
Comparator / control treatment
16 pre-pubertal individuals with CF form the same hospital clinical will be recruited exactly the same as the intervention subjects. This group will be involved in baseline line and 12 week follow-up assessments, but not perform the 12 WBVT intervention or 2 x 4 weekly reviews via teleheath. The control subjects will perform their routine daily physiotherapy and attend usual clinical scheduled appointments. This group then will form the comparator group as "usual care".
Control group
Active

Outcomes
Primary outcome [1] 301717 0
Lean body mass via DXA (LBM/ht2)
Timepoint [1] 301717 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [1] 333668 0
Bone mineral density via, (1) dual-energy X-ray absorptiometry (DXA, areal BMD, gm/cm2) and (2) peripheral quantitative computed tomography (pQCT, gm/cm3).
Timepoint [1] 333668 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [2] 335761 0
respiratory function via lung clearance index and respiratory function test
Timepoint [2] 335761 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [3] 335764 0
Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R).
Timepoint [3] 335764 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [4] 335765 0
lower limb strength via vertical jump height
Timepoint [4] 335765 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [5] 335766 0
Core muscle physiology (pertaining to the external and internal obliques, and transverse abdominis), specifically the activation (contraction and relaxation) and size of the transverse abdominis via abdominal real time ultrasound.
Timepoint [5] 335766 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [6] 335767 0
grip strength via hand held dynamometry
Timepoint [6] 335767 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [7] 335768 0
Measure of thoracic kyphosis, using the tragus to wall measurement, i.e., the distance of a subject standing upright against a wall to the tragus (part of the ear).
Timepoint [7] 335768 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.
Secondary outcome [8] 335769 0
questionnaire for urinary continence diagnosis (QUID)
Timepoint [8] 335769 0
Each participant will have final measures taken within a week of completion of the 12 week program. Individuals will have a staggered commencement of the study between Jan- November 2017. Differences between the groups will be analysed at the completion of the intervention; to be expected in January 2018.

Eligibility
Key inclusion criteria
Young individuals registered with the CF respiratory clinic at Lady Cilento Children's Hospital, South Brisbane; confirmed diagnosis of cystic fibrosis; over 6 years of age; Pre-pubertal (Tanner stage 1); ability to attend regular clinical visits at LCCH every 4 weeks over the duration of the 12 week project; must have access to computer for the provision of telehealth.

Children of aboriginal and Torres Straight Islander descent are infrequently diagnosed with CF. However, if recruited, it is anticipated there will not be any concerns to the participation in the study as the outcomes measures do not relate to culture or descent.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary bone disorder; pubertal (greater or equal to Tanner stage 2); non-English speaking; People with a disability or mental impairment

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre-post t-test and Correlations (Primary outcome measure (dependent variable) = lean body mass) against secondary measures of bone parameters and respiratory function

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/03/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7846 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 15789 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 296207 0
Government body
Name [1] 296207 0
Queensland Government Health Practitioners Research Scheme
Country [1] 296207 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
501 Stanley St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 295115 0
University
Name [1] 295115 0
The University of Queensland
Address [1] 295115 0
CCHR
62 Graham St
South Brisbane, QLD 4101
Country [1] 295115 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297446 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 297446 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 297446 0
Australia
Date submitted for ethics approval [1] 297446 0
15/07/2016
Approval date [1] 297446 0
03/02/2017
Ethics approval number [1] 297446 0
HREC/16/QRCH/103AM01. SSA/16/QRCH/364

Summary
Brief summary
With increasing life expectancy of individuals with cystic fibrosis (CF), the musculoskeletal sequelae of this chronic disease results in an increased burden of management and demand on healthcare services. Bone mineral density deficits, with fragility fractures (osteoporosis) and, more recently, reduced muscle mass (sarcopenia), are recognised as a long term health concerns. Importantly, muscle mass has been shown as an independent predictor of bone accrual in individuals with CF.
Whole body vibration training (WBVT) has been shown to have a therapeutic impact on bone and muscle response in adults, and some paediatric cohorts, with CF. These data appear to support WBVT as an emerging therapeutic alternative for preventing/reversing sarcopenia and possibly osteoporosis.
Efficient and novel models of service delivery are required to provide equitable, safe, and effective healthcare across extensive geographical regions of the state of Queensland. Telehealth provides a viable means of accessing specialist health services not available to consumers in their local areas. Queensland Health has recently provided infrastructure to support telehealth within regional facilities and homes, especially for chronic disease management.
Our project aims to demonstrate the utility of telehealth-supported home treatments with WBVT via a model of service delivery which reduces travel time, costs, and negative impacts on quality of life(QOL), while providing an efficacious clinical intervention.
A state-wide study of 32 pre-pubertal outpatients with CF, over 6 years of age, will be recruited to the study conducted over a 12-week period. Stratified randomisation will allocate the 32 subjects to either a control group or WBVT group. The control cohort (n=16) will continue their normal physiotherapy airway clearance regime. The WBVT cohort (n=16) will participate in the WBVT arm. Participants in the WBVT cohort will be reviewed either face-to-face or via telehealth at weeks 2,4,8 of their program. WBVT participants will perform a standardised WBVT program (20 minutes in duration), 5 times a week, in combination with their normal physiotherapy airway clearance regime. Outcome measures will be taken at weeks 0 and 12 of the program, and include primary outcome measures of lean body mass (LBM) via dual-energy X-ray absorptiometry (DXA), converted as an index (LBM/Ht2). Secondary outcome measures include Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R), Spirometry and Lung Clearance Index (LCI), muscle and bone parameters via DXA and peripheral Quantitative Computed Tomography (pQCT), vertical jump height, transversus abdominus real-time ultrasound, urinary continence and thoracic kyphosis measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68798 0
Miss Elise Alexander
Address 68798 0
7A Clinical Directorate
Level 7
Lady Cilento Children's Hospital
South Brisbane
QLD 4101
Country 68798 0
Australia
Phone 68798 0
+61438170287
Fax 68798 0
Email 68798 0
[email protected]
Contact person for public queries
Name 68799 0
Dr Denise Brookes
Address 68799 0
Centre of Children's Health Research
Level 6, 62 Graham St
South Brisbane
QLD 4101
Country 68799 0
Australia
Phone 68799 0
+61409053374
Fax 68799 0
Email 68799 0
[email protected]
Contact person for scientific queries
Name 68800 0
Dr Denise Brookes
Address 68800 0
Centre of Children's Health Research
Level 6, 62 Graham St
South Brisbane
QLD 4101
Country 68800 0
Australia
Phone 68800 0
+61409053374
Fax 68800 0
Email 68800 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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