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Telehealth compared to face to face delivered whole body vibration training in children with Cystic Fibrosis (CF).

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000867392
Enrollment
32
Registered
2017-06-13
Start date
2017-03-06
Completion date
2017-07-31
Last updated
2017-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Lady Cilento Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
No

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.

Exclusion criteria

Primary bone disorder; pubertal (greater or equal to Tanner stage 2); non-English speaking; People with a disability or mental impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026