Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000090213
Ethics application status
Approved
Date submitted
28/10/2008
Date registered
10/02/2009
Date last updated
31/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Vibration Training and Detraining on Muscle Function in Patients with Cystic Fibrosis
Scientific title
Effect of Vibration Training and Detraining on Muscle Function in Patients with Cystic Fibrosis: A Pilot Efficacy Trial.
Secondary ID [1] 283498 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis 3888 0
Condition category
Condition code
Respiratory 4074 4074 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
whole body vibration training. Patients will be required to stand on the vibration platform with a knee angle of 150 degrees, 3 days a week for four weeks. Frequency is 20Hz for the first 2 weeks, and 22 Hz for the remaining 2 weeks, with a 1mm amplitude maintained throughout. Patients wear socks while on the platform, and each training session goes for 30 minutes in total, with intermittent exposure of 1 minute vibration, 1 minute rest (standing on the platform). The proceeding washout period is also four weeks.
Intervention code [1] 3589 0
Treatment: Other
Intervention code [2] 3601 0
Diagnosis / Prognosis
Comparator / control treatment
no treatment. The first four weeks of the three month study is the control period whereby the patients maintain normal levels of physical activity as reported at baseline, and recieve no active intervention. This is to assess the changes that occur in the population due to growth, learning and maturation prior to including the intervention.

The subjects act as thier own controls. The first month is the control period. The second month is the intervention of vibration training. The third month is a washout period where detraining effects may be observed.
Control group
Active

Outcomes
Primary outcome [1] 4955 0
muscle strength. Dynamic muscle strength will be assessed on Keiser pneumatic-resistance training equipment with K400 electronics (Keiser Sports Health Equipment, Inc., Fresno, CA) using one repetition maximum (1RM) in three bilateral exercises: knee extension, chest press and horizontal leg press.
Timepoint [1] 4955 0
baseline, one month (post control), two months (post training), three months (post de-training)
Primary outcome [2] 4956 0
muscle power. Power will be measured at 60% of the patients current 1RM, as peak power has been observed between 50-75% 1RM. Three maximal explosive efforts were performed with 1 minute rest in between. The highest power achieved for each of the three exercises (knee extension, chest press, leg press) will be recorded and used in analyses.
Timepoint [2] 4956 0
baseline, one month (post control), two months (post training), three months (post de-training)
Primary outcome [3] 4957 0
muscle endurance. 90% of the patients baseline 1RM will be used to assess endurance, once again on the same machines (knee extension, chest press, leg press), with the number of completed repetitions performed with the load being recorded and used in analysis.
Timepoint [3] 4957 0
baseline, one month (post control), two months (post training), three months (post de-training)
Secondary outcome [1] 8363 0
Maximal aerobic capacity will be assessed with a treadmill walk protocol. Measures will include peak oxygen consumption (VO2peak), oxygen uptake efficiency slope (OUES)
Timepoint [1] 8363 0
baseline, one month (post control), two months (post training), three months (post de-training)
Secondary outcome [2] 8364 0
respiratory function will measure forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC), forced midexpiratory flow rate (FEF25-75%) and using spirometry and maximum voluntary ventilation (MVV), vital capacity, residual volume, total lung capacity will be measured by body plethysmography;
Timepoint [2] 8364 0
baseline, one month (post control), two months (post training), three months (post de-training)
Secondary outcome [3] 8365 0
Health-Related Quality of Life assessed by Cystic Fibrosis Questionnaire
Timepoint [3] 8365 0
baseline, one month (post control), two months (post training), three months (post de-training)
Secondary outcome [4] 8366 0
Nutritional status will be assessed by a three day food diary completed at home
Timepoint [4] 8366 0
baseline, one month (post control), two months (post training), three months (post de-training)

Eligibility
Key inclusion criteria
patients with cystic fibrosis aged 8 years or older
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*severe cystic fibrosis (CF) (FEV1 < 40% predicted)
*inability to stand unaided for 30 min
*long bone or vertebral fracture in past 6 months
*past/present history of osteoarthritis
*CF liver disease with portal hypertension, neuropathy or myopathy
*Vitamin D deficiency (25-hydroxyvitamin D) <39 nmol/L (in past 3 months).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2008
Actual
31/07/2008
Date of last participant enrolment
Anticipated
1/09/2008
Actual
27/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4048 0
University
Name [1] 4048 0
Cumberland Research Grant Category B, Faculty of Health Sciences, The University of Sydney
Country [1] 4048 0
Australia
Funding source category [2] 4060 0
University
Name [2] 4060 0
Faculty of Health Sciences, The University of Sydney
Country [2] 4060 0
Angola
Primary sponsor type
University
Name
Faculty of Health Sciences, The University of Sydney
Address
PO Box 170
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 3641 0
Hospital
Name [1] 3641 0
The Children's Hospital at Westmead
Address [1] 3641 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, NSW
Country [1] 3641 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6155 0
Royal Alexandra Hospital for Children
Ethics committee address [1] 6155 0
Ethics committee country [1] 6155 0
Australia
Date submitted for ethics approval [1] 6155 0
Approval date [1] 6155 0
23/07/2008
Ethics approval number [1] 6155 0
08/CHW/37

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

Contacts
Principal investigator
Name 29064 0
Dr Dr Rhonda Orr
Address 29064 0
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 29064 0
Australia
Phone 29064 0
+61 2 93519475
Fax 29064 0
+61 2 93619204
Email 29064 0
[email protected]
Contact person for public queries
Name 12221 0
Dr. Rhonda Orr
Address 12221 0
C43 - Cumberland Campus
The University of Sydney
75 East street
Lidcombe
NSW 2141 Australia
Country 12221 0
Australia
Phone 12221 0
+61 2 9351 9475
Fax 12221 0
+61 2 9351 9204
Email 12221 0
[email protected]
Contact person for scientific queries
Name 3149 0
Dr. Rhonda Orr
Address 3149 0
C43 - Cumberland Campus
The University of Sydney
75 East street
Lidcombe
NSW 2141 Australia
Country 3149 0
Australia
Phone 3149 0
+61 2 9351 9475
Fax 3149 0
+61 2 9351 9204
Email 3149 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.