Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000508875
Ethics application status
Approved
Date submitted
10/05/2012
Date registered
11/05/2012
Date last updated
11/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whole-body vibration and chronic obstructive pulmonary disease
Scientific title
Efficacy of whole-body vibration on exercise tolerance and functional performance of the lower limbs for people with chronic obstructive pulmonary disease
Secondary ID [1] 280469 0
Nil
Universal Trial Number (UTN)
U1111-1130-6211
Trial acronym
WBV and COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 286444 0
Condition category
Condition code
Respiratory 286705 286705 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a non-randomised placebo cross-over intervention based in a community setting. Participants diagnosed with COPD will complete six weeks of whole-body vibration training and then after a two week washout period, will complete a six week placebo training intervention. Participants will complete training sessions twice a week. The duration of the study is 14 weeks. Community-dwelling older adults with chronic obstructive pulmonary disease will provide informed voluntary consent to participate. Outcome measures will include selected variabes of exercise tolearance and functional performance of the lower limbs.

The WBV intervention will consist 12 WBV sessions over a consecutive six week period. The participants will complete two vibration sessions per week separated by at least 48 hours. Efficacy of session frequency had been previously established for healthy community dwelling older adults. A WBV session will consist of five, 60 second vibration bouts, interspersed with 60 seconds of passive rest. Although the most effective protocol is yet to be established, the selected protocol had been used previously to establish efficacy of WBV interventions. During rest, the participant will remain on the vibration platform and will be encouraged to stand with a posture that resembles the ‘anatomical position’. More specifically, the participant assumes a standing position with the feet together, the arms to the side, and the head, eyes and palms facing forwards. The forearms are supinated.

A side alternating vibration platform will be used. For each vibration bout, platform frequency will be 25 Hz, peak-to-peak displacement 2.0 mm, peak acceleration ~24.67 m.s-2, and gravitational force ~2.52 g. The vibration platform peak-to-peak displacement and frequency were validated prior to this proposal in an unpublished pilot study. Foot placement (second toe) will be equidistant, 20 cm from axis of rotation. The participant will wear flat soled shoes. Skidding will be checked according to the recommended method of the International Society of Musculoskeletal and Neuronal Interactions. A piece of paper will be placed under the foot during a vibration bout to ensure constant contact with the vibration platform. The participant will be required to stand with ~20 degrees knee flexion to allow transmission of vibration about the lower limbs. Knee angle will be filmed, and later quantified across the intervention for each participant.
Intervention code [1] 284829 0
Treatment: Devices
Intervention code [2] 284830 0
Treatment: Other
Comparator / control treatment
A prototype vibration platform will be used for the PLACEBO intervention. For each vibration bout, platform frequency will be 25 Hz, peak-to-peak displacement ~0.0 mm, peak acceleration ~0.00 m.s-2, and gravitational force ~0.0 g (cognisant that the Earth’s gravitational force is constant 1.0 g). Participants will be required to follow the same procedure of the WBV intervention. Participants will be told the PLACEBO intervention is an “ultra-low frequency” vibration intervention that is “very different” to the aforementioned WBV intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 287099 0
Primary outcome 1: the 5-chair stands test quantified with stop watch
Timepoint [1] 287099 0
baseline and every 2 weeks across the 14 week study
Primary outcome [2] 287100 0
Primary outcome 2: the timed up and go test quantified with stop watch
Timepoint [2] 287100 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [1] 297369 0
Secondary outcome 1: stride length quantified with electronic walkway
Timepoint [1] 297369 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [2] 297370 0
Secondary outcome 2: stride time quantified with electronic walkway
Timepoint [2] 297370 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [3] 297371 0
Secondary outcome 3: stride velocity quantified with electronic walkway
Timepoint [3] 297371 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [4] 297372 0
Secondary outcome 4: perceived dyspnoea quantified with VAS
Timepoint [4] 297372 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [5] 297373 0
Secondary outcome 5: heart rate (beats per minute)
Timepoint [5] 297373 0
baseline and every 2 weeks across the 14 week study
Secondary outcome [6] 297374 0
Secondary outcome 6: saturation of haemoglobin (%) quantified with pulse oximeter
Timepoint [6] 297374 0
baseline and every 2 weeks across the 14 week study

Eligibility
Key inclusion criteria
Participants must be fully independent in residence and have well managed, stable Stage II COPD according to the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria. Participants must be free of contraindicators to physical activity as well as contraindicators to whole-body vibration.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not community dwelling (functionally dependent on external care)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Randomisation was not used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
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)
Recruitment postcode(s) [1] 5274 0
3938
Recruitment postcode(s) [2] 5275 0
3810
Recruitment postcode(s) [3] 5276 0
3178
Recruitment postcode(s) [4] 5277 0
3977

Funding & Sponsors
Funding source category [1] 285228 0
Self funded/Unfunded
Name [1] 285228 0
Country [1] 285228 0
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade,
Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 284096 0
None
Name [1] 284096 0
Address [1] 284096 0
Country [1] 284096 0
Other collaborator category [1] 260795 0
Hospital
Name [1] 260795 0
Monash Medical Centre
Address [1] 260795 0
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Country [1] 260795 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287237 0
Southern Health Human Research Ethics Committee A
Ethics committee address [1] 287237 0
Research Directorate
Southern Health
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [1] 287237 0
Australia
Date submitted for ethics approval [1] 287237 0
Approval date [1] 287237 0
09/09/2011
Ethics approval number [1] 287237 0
11222A
Ethics committee name [2] 287238 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 287238 0
115 Victoria Parade,
Fitzroy, Victoria 3065
Ethics committee country [2] 287238 0
Australia
Date submitted for ethics approval [2] 287238 0
Approval date [2] 287238 0
07/04/2011
Ethics approval number [2] 287238 0
V2011 01

Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) is a respiratory condition characterised by dyspnoea, excessive sputum production, chronic cough, bronchitis and emphysema. Functionally, exercise tolerance is poor for people with COPD and is linked to difficulty in performing daily tasks. More specifically, exercise difficulties are due partly to dyspnoea and lower limb skeletal muscle dysfunction. The benefits of gentle exercise that does not exacerbate the disease while improving exercise tolerance is salient. Whole-body vibration is a mode of gentle exercise known to improve muscular function of the lower limbs, yet efficacy has not been investigated for a whole-body vibration intervention conducted in a community setting for people with COPD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34163 0
Address 34163 0
Country 34163 0
Phone 34163 0
Fax 34163 0
Email 34163 0
Contact person for public queries
Name 17410 0
Trentham Furness
Address 17410 0
School of Exercise Science
Australian Catholic University
115 Victoria Parade,
Fitzroy, Victoria 3065
Country 17410 0
Australia
Phone 17410 0
+61399533538
Fax 17410 0
Email 17410 0
[email protected]
Contact person for scientific queries
Name 8338 0
Trentham Furness
Address 8338 0
School of Exercise Science
Australian Catholic University
115 Victoria Parade,
Fitzroy, Victoria 3065
Country 8338 0
Australia
Phone 8338 0
+61399533538
Fax 8338 0
Email 8338 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
SourceTitleYear of PublicationDOI
Dimensions AIBenefits of whole-body vibration to people with COPD: a community-based efficacy trial2014https://doi.org/10.1186/1471-2466-14-38
N.B. These documents automatically identified may not have been verified by the study sponsor.