ANZCTR - Registration

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]

NIL

Universal Trial Number (UTN)

U1111-1187-1861

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cystic Fibrosis

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Human Genetics and Inherited Disorders

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]

Prevention

Intervention code [2]

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]

Lean body mass via DXA (LBM/ht2)

Timepoint [1]

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]

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]

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]

respiratory function via lung clearance index and respiratory function test

Timepoint [2]

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]

Cystic Fibrosis Quality of Life Questionnaire-Revised (CFQ-R).

Timepoint [3]

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]

lower limb strength via vertical jump height

Timepoint [4]

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]

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]

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]

grip strength via hand held dynamometry

Timepoint [6]

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]

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]

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]

questionnaire for urinary continence diagnosis (QUID)

Timepoint [8]

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

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]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Queensland Government Health Practitioners Research Scheme

Country [1]

Australia

Primary sponsor type

Hospital

Name

Lady Cilento Children's Hospital

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Queensland

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children’s Health Queensland Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

15/07/2016

Approval date [1]

03/02/2017

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Miss Elise Alexander

Address

7A Clinical Directorate
Level 7
Lady Cilento Children's Hospital
South Brisbane
QLD 4101

Country

Australia

Phone

+61438170287

Email

[email protected]

Contact person for public queries

Name

Denise Brookes

Address

Centre of Children's Health Research
Level 6, 62 Graham St
South Brisbane
QLD 4101

Country

Australia

Phone

+61409053374

Email

[email protected]

Contact person for scientific queries

Name

Denise Brookes

Address

Centre of Children's Health Research
Level 6, 62 Graham St
South Brisbane
QLD 4101

Country

Australia

Phone

+61409053374

Email

[email protected]

Trial Review

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