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Trial registered on ANZCTR


Registration number
ACTRN12609000520235
Ethics application status
Approved
Date submitted
19/06/2009
Date registered
30/06/2009
Date last updated
11/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vibration Training in Children with Cystic Fibrosis: Function, Power, Bone.
Scientific title
Does vibration training improve mucle power, bone strength and physical function in children and adolescents with cystic fibrosis?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 236956 0
Condition category
Condition code
Human Genetics and Inherited Disorders 237306 237306 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole body vibration training (WBVT) using a vibration platform.

WBVT using a vibration platform is a new, simple and safe training method that has been shown to improve muscle mass and bone density. WBVT has been used in a number of clinical settings including healthy athletes, untrained individuals, the elderly and in individuals with cystic fibrosis. It requires the participant to stand on a vibration plate that moves rapidly (10-20Hz) up and down over a small distance (10mm) generating a vibration stimulus. The vibration causes the muscles in the legs and body to contract resulting in increased muscle mass. WBVT is believed to stimulate bone formation due to the increased forces applied to the bone by the increased muscle mass seen after WBVT. The bone responds to these increased forces by altering its biomechanical properties (mineral content and geometry) to increase its density and strength.
Participants will perform WBVT daily for six months on a vibration plate that will be placed in the participant’s home. Each daily session consists of four 3 minute WBVT sessions with short breaks in between each session. The total daily training time will take about 20 minutes.
Intervention code [1] 236732 0
Treatment: Devices
Comparator / control treatment
Patients will act as their own controls. Patients will be randomised into either 6 months observation followed by 6 months of WBVT, or 6 months WBVT followed by 6 months observation.
Control group
Active

Outcomes
Primary outcome [1] 238114 0
Peak Jump Force (PJF). PJF will be assessed by the Single Two-Legged Jump on the Leonardo ground reaction force plate(Stratec, Pforzheim, Germany). The child will be instructed to jump as high as possible. A total of 3 jumps will be performed and the jump that results in the maximum PJF will be used for analysis. The raw score and values adjusted for weight and height will be evaluated. Measures of Peak Jump Power (PJP) and Jump Velocity will also be recorded from this test.
Timepoint [1] 238114 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Primary outcome [2] 238151 0
Lung Clearance Index (LCI) using Multiple Breath Nitrogen Washout. This involves the subject breathing tidally through a mouth-piece whilst washing a tracer gas, nitrogen, from their lungs with 100% oxygen. Nitrogen exists within the lung at a concentration of 4.9% and thus this method works by reduction of this concentration as it is replaced with inspired oxygen. Subjects initially stabilise tidal breathing through the mouth-piece then delivery of 100% oxygen begins. Nitrogen concentration is measured at the mouth and flow rates are calculated by the computer. The subject continues tidal breathing until the expired nitrogen concentration falls below 1.5% for 3 consecutive breaths. The LCI is calculated from the cumulative volume of expired gas required to reduce the nitrogen concentration to 2% divided by the functional residual capacity.
Timepoint [2] 238151 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [1] 242374 0
Chair Rising Test (CRT). The CRT will be performed on the Leonardo Jumping Platform (Stratec, Pforzheim, Germany). The child will be seated on the chair with arms crossed in front of them with hands on the shoulders. They will then be asked to stand to an upright position as fast as possible then sit down straight away. This is repeated 5 times in one cycle. Time to perform the test and muscle Power and Force generated during the test will be evaluated.
Timepoint [1] 242374 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [2] 242375 0
Spirometry. Measures of spirometry consist of forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced expiratory flow (FEF25-75%) and peak expiratory flow (PEF). These will be performed according to standard American Thoracic Society spirometric techniques. Results will be expressed as a percentage of predicted values with the use of standard reference ranges.
Timepoint [2] 242375 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [3] 242376 0
Body Plethysmography. Body plethysmography will measure vital capacity (VC), residual volume (RV), total lung capacity (TLC) and functional residual capacity (FRC) using the Sensormedics Vmax22 and Autobox systems. These will be performed according to ATS standards. Results will be expressed as a percentage of predicted values with the use of standard reference ranges.
Timepoint [3] 242376 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [4] 242377 0
The Cystic Fibrosis Clinical Score (CFCS). The CFCS is a symptom score system that evaluates the day-to-day changes seen in CF patients admitted to hospital for a pulmonary exacerbation. In its 1999 validation study, the score was shown to be a predictor and optional surrogate of pulmonary function in this population. For an individual within this study, CFCS will be used as a measure of the participant's severity of pulmonary exacerbation and any change during the admission. For between group analyses, the improvement in CFCS between the WBVT and control groups will be assessed. The score assesses 5 symptoms (level of energy, production of sputum, cough, shortness of breath and appetite) as well as 5 physical findings (temperature, weight, degree of air exchange, lung crackles and respiratory rate/retractions).
Timepoint [4] 242377 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [5] 242378 0
Maximum Force in relation to body weight. Children will be asked to perform a Multiple One Leg Jump on the Leonardo Jumping Platform (Stratec, Pforzheim, Germany). They will be instructed to jump up and down on their dominant leg as fast as possible and to only land on the forefoot. This activity provides data on the maximum force that can be generated within a limb. Maximum force appears to be an important determinant of bone strength.
Timepoint [5] 242378 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [6] 242379 0
Peripheral Quantitative Computer Tomography (pQCT) of the non-dominant Tibia. Three sites will be analysed: 1) the distal tibial epiphysis (4% site) for total and trabecular volumetric bone mineral density (vBMD), bone mineral content (BMC) and total bone cross-sectional area (CSA). 2) the tibial diaphysis (38% site)- total and trabecular vBMD, BMC and total bone CSA. 3) The tibial diaphysis (66% site)- for total bone CSA, cortical CSA, cortical thickness, cortical vBMD, BMC, muscle CSA and stress-strain index (SSI)
Timepoint [6] 242379 0
Baseline, 6 and 12 months after randomisation.
Secondary outcome [7] 242380 0
Biochemical Analyses. Blood will be collected for calcium, magnesium, parathyroid hormone, phosphorus, alkaline phosphatase, vitamin D levels, osteocalcin and urine deoxypyridinoline.
Timepoint [7] 242380 0
Baseline, 6 and 12 months after randomisation.
Secondary outcome [8] 242381 0
Oral Glucose Tolerance Test (OGTT). During the OGTT, a known oral glucose load (1.75g/kg to a maximum of 75g) is administered orally after at least 10 hours of fasting. This allows the function of the pancreas and its ability to secrete insulin in response to a known glucose load to be determined. Blood samples are taken from an intravenous sampling canula at baseline, before ingestion of the glucose drink, and then every 30 minutes for 3 hours. Measuring glucose and insulin concentrations every half hour during the 3 hour OGTT is clinically useful to assess the glucose response and degree of insulin deficiency.
Timepoint [8] 242381 0
Baseline, 6 and 12 months after randomisation.
Secondary outcome [9] 242382 0
Dual Energy X-Ray Absorptiometry (DXA). Total Body, Lumbar Spine and Distal Femur DXA. Variables to be analysed include bone mineral content (BMC) relative to age, body height, body weight, projected bone area and lean tissue mass. Analysis of skeletal subregions (upper limbs, trunk, pelvis, lower limbs) will be performed to assess the site-specificity of the changes compared to normative data. Using subregional analysis, the main outcome parameter is lower extremity bone mineral content. Lower extremity lean tissue mass will also be assessed as will distal femur BMC and areal bone mineral density (aBMD). Other measures include estimated volumetric bone mineral density (vBMD) of the lumbar spine (L2 to L4) and total body BMC and BMD. DXA directly measures bone mineral content (BMC; expressed in grams) and the bone's two-dimensional projection area (in cm2). aBMD is calculated by dividing the BMC by the projection area (g/cm2). vBMD is the ratio between BMC and extrapolated bone volume (in cm3). Bone volume is derived from bone projection area (in cm2) as described by using the formula: Bone volume = (projection area)^1.5.
Timepoint [9] 242382 0
Baseline, 6 and 12 months after randomisation.
Secondary outcome [10] 242383 0
Modified Bruce Protocol Treadmill Test. Peak aerobic capacity will be assessed by a modified Bruce protocol on an electronic treadmill. Breath-by-breath gas analysis will be used to determine peak oxygen uptake (VO2), exercise ventilation (VE), breathing reserve (BR) at maximal exercise, and respiratory quotient (RQ). The results will be expressed in terms of lean body weight. A validated rating of perceived exertion scale, also known as the Borg Scale will be administered throughout the duration of the treadmill test to quantify dyspnoea.
Timepoint [10] 242383 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [11] 242384 0
The Wingate Anaerobic Test. This test will be performed on an electronically braked cycle ergometer. Participants will have a one minute warm up period pedalling against minimal resistance. They will then be instructed to pedal as fast as they can for 30 seconds against a resistance applied through an integrated computer program that is set relative to weight, age and gender. During the test gas exchange will be measured using breath-by-breath gas analysis. Anaerobic performance will be reported as peak power and mean power and will give information about the rate of fatigue known as the fatigue index.
Timepoint [11] 242384 0
Baseline and 3, 6, 9 and 12 months after randomisation.
Secondary outcome [12] 242385 0
The Cystic Fibrosis Questionnaire (CRQ). This is a disease specific, health related quality of life measure for individuals with CF. The questionnaire has developmentally appropriate versions; Child, for children aged 6-13 years, with an interviewer format for those aged 6-11years and a self report format for those 12-13 years; Parent, for parents of children with CF aged 6-13 years; and a Teen/adult for those 14 years and older. The questionnaire encompasses general domains of health related quality of life: physical functioning, role functioning, vitality, health perception, emotional functioning and social functioning, as well as domains specific to CF: body image, eating disturbances, treatment burden, respiratory and digestive symptoms. The teen/adult version of the questionnaire has been validated as a reliable measure of health related quality of life for individuals with CF.
Timepoint [12] 242385 0
Baseline and 3, 6, 9 and 12 months after randomisation.

Eligibility
Key inclusion criteria
Children and adolescents with cystic fibrosis aged between 6-18 years who can perform reproducible pulmonary function tests. Baseline forced expiratory volume in one second (FEV1) greater than 25% of predicted normal values.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Long Bone or vertebral fracture within the preceding 6 months.
Past or present history of arthritis.
CF liver disease with portal hypertension.
Inability to stand unaided for 30 minutes.
Co-existent neuropathy or myopathy.
Vitamin D deficiency (25-hydroxyvitamin D <39nmol/L) within last 3 months.
Severe CF (FEV1 < 25% predicted).
Use of medication known to interfere with bone metabolism.
History of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrolment: Anabolic agents, Oestrogen (except contraceptives), Progestogens (except contraceptives), Calcitriol, Calcitonin, Fluoride (except dental health products), Bisphosphonates, Growth hormone, Parathyroid hormone (PTH), Strontium.

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



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237183 0
Hospital
Name [1] 237183 0
The Children's Hospital at Westmead
Country [1] 237183 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 4676 0
None
Name [1] 4676 0
Address [1] 4676 0
Country [1] 4676 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239277 0
Children's Hospital Westmead Human Research Ethics Committee
Ethics committee address [1] 239277 0
Ethics committee country [1] 239277 0
Australia
Date submitted for ethics approval [1] 239277 0
Approval date [1] 239277 0
Ethics approval number [1] 239277 0

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

Contacts
Principal investigator
Name 29721 0
Address 29721 0
Country 29721 0
Phone 29721 0
Fax 29721 0
Email 29721 0
Contact person for public queries
Name 12968 0
Dr Craig Munns
Address 12968 0
Department of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
westmead NSW 2145
Country 12968 0
Australia
Phone 12968 0
61 2 9845 3142
Fax 12968 0
Email 12968 0
craigm2@chw.edu.au
Contact person for scientific queries
Name 3896 0
Dr Craig Munns
Address 3896 0
Department of Endocrinology and Diabetes
The Children's Hospital at Westmead
Locked Bag 4001
westmead NSW 2145
Country 3896 0
Australia
Phone 3896 0
61 2 9845 3142
Fax 3896 0
Email 3896 0
craigm2@chw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
No additional documents have been identified.