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Trial registered on ANZCTR
Registration number
ACTRN12619001004156
Ethics application status
Approved
Date submitted
4/07/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Improving recovery in wheelchair basketball players
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Scientific title
The effect of a pneumatic compression device on recovery in wheelchair basketball players
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Secondary ID [1]
298641
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None
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Universal Trial Number (UTN)
U1111-1235-1150
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury
313569
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Amputee
313570
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Spina Bifida
313571
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Cerebral palsy
313572
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Condition category
Condition code
Physical Medicine / Rehabilitation
312004
312004
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will be conducted by a University of Waikato student as part of their Masters degree requirements. It will take place at the usual training venue of the Waikato wheelchair basketball team.
This study is hoping to show whether a recovery method used by many elite athletes is helpful to wheelchair athletes. The pneumatic compression device works like a massage. The device is worn on your arms and different parts within the sleeves inflate and deflate continuously, in a similar way to a blood pressure cuff. The main goal of this study is to see if this device can help with recovery when athletes are required to complete multiple trainings session during the day.
With a partner, each participant will be required to take part in a series of performance tests (listed below) specific to the demands of wheelchair basketball, as well as a high intensity training session. The aim of this session is to cause fatigue. A second round of performance tests will take place, followed by a recovery session, where one member of each pair will wear the compression arms while the other does not. The performance tests will then be repeated. This process will be repeated a week later, however the roles during the recovery section will be reversed so that both partners will have used the compression device. Each session will take approximately two and half hours, so total commitment time will be about five hours.
Performance tests include:
- Maximal medicine ball chest pass – the aim is to throw the medicine ball as far as possible.
- Repeated wheelchair sprints – a series of sprints with a short rest in between them.
- Hand grip strength – assesses grip strength by measuring how hard a person can squeeze.
- Blood lactate concentration – this requires a finger prick test. Only a couple of drops of blood are needed. All samples will be disposed of after each session.
- Muscle soreness algometer – the probe measures the pressure inside the muscle and how sensitive a person is to that muscle pressure.
The high intensity training session will include:
Warm up
- 5 x easy laps around court, gradually increasing speed + 3 x half court tows with a partner.
- Dynamic stretching (arm swings, thoracic rotations.)
High Intensity
- 6 x court sprints (wheel back to start)
- 6 x 30 second (with 10-15 second breaks) Figure 8s (wheeling round cones in figure 8 direction)
- 6 x court sprints with shot at hoop (wheel back to start)
Cool down
- 3 x easy laps, gradually slowing down.
This participants in this study will remain anonymous. No details will be included that may enable the identification of the participants.
The device will be worn for 60 minutes during the recovery period only. Participants not using the device will be able to sit and relax. The device will not be worn during the performance tests. The device has an inflation time of 26 seconds and a deflation time of 15 seconds. This will continue throughout the 60 minute period. It will be set to a pressure of 80 mm Hg.
The intervention will be administer by myself (lead investigator), a Masters student with experience working with individuals with physical disabilities.
My university supervisor will also be present. He is currently a lecturer at the University of Waikato but has extensive experience as a sports physiologist, working with elite athletes.
The overall timeline of the study procedure is as follows:
Performance test 1 (15-20 mins)
High intensity session (20 mins)
Performance tests (15-20 mins)
Recovery intervention (60 mins)
Performance tests (15-20 mins)
target intensity will be 12-14 RPE
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Intervention code [1]
314946
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Treatment: Devices
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Comparator / control treatment
The participants will not use the pneumatic compression device following the training session.
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Control group
Active
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Outcomes
Primary outcome [1]
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Maximal medicine ball chest pass
Participant must throw 5kg medicine ball as far as they can.
3 times - 1 minute rest in between each throw
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Assessment method [1]
320616
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Timepoint [1]
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Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
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Primary outcome [2]
320617
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Repeated wheelchair sprints
3 x 15 metre sprints
45 sec rest in between.
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Assessment method [2]
320617
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Timepoint [2]
320617
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Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
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Primary outcome [3]
320618
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Blood lactate - using finger prick test.
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Assessment method [3]
320618
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Timepoint [3]
320618
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Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
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Secondary outcome [1]
372214
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Muscle soreness - measured using algometer that measures amount of pressure within the muscle
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Assessment method [1]
372214
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Timepoint [1]
372214
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Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
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Secondary outcome [2]
372215
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Hand grip strength - measured using dynamometer
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Assessment method [2]
372215
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Timepoint [2]
372215
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Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
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Eligibility
Key inclusion criteria
To take part in this study participants must be over 18 years of age, be regular wheelchair basketball players, physically well and injury free
Physical disabilities include spinal cord injury, spina bifida, amputee, cerebral palsy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Individuals who do not regularly play wheelchair basketball, are injured or have any health conditions that could be made worse through participating
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/07/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21662
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New Zealand
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State/province [1]
21662
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Funding & Sponsors
Funding source category [1]
303182
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University
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Name [1]
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University of Waikato
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Address [1]
303182
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Knighton Road
Hillcrest
Hamilton
3216
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Country [1]
303182
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New Zealand
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Primary sponsor type
University
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Name
University of Waikato
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Address
Knighton Road
Hillcrest
Hamilton
3216
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
303194
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Country [1]
303194
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303744
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Health and Disability Ethics Committees
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Ethics committee address [1]
303744
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Ministry of Health 133 Molesworth Street PO Box 5013 Wellington 6011
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Ethics committee country [1]
303744
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New Zealand
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Date submitted for ethics approval [1]
303744
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Approval date [1]
303744
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25/06/2019
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Ethics approval number [1]
303744
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Summary
Brief summary
This research is being completed as part of a Masters level thesis through the University of Waikato, Hamilton. This study is hoping to show whether a recovery method used by many elite athletes is helpful to wheelchair athletes. The pneumatic compression device works like a massage. The device is worn on your arms and different parts within the sleeves inflate and deflate continuously, in a similar way to a blood pressure cuff. The main goal of this study is to see if this device can help with recovery when athletes are required to complete multiple trainings session during the day. This may also show if the device is useful during wheelchair basketball tournaments, when multiple games are played during the day.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Alison Oliver
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Address
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Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
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Country
94646
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New Zealand
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Phone
94646
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+64 78554917
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Fax
94646
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Email
94646
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[email protected]
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Contact person for public queries
Name
94647
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Alison Oliver
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Address
94647
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Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
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Country
94647
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New Zealand
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Phone
94647
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+64 78554917
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Fax
94647
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Email
94647
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[email protected]
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Contact person for scientific queries
Name
94648
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Alison Oliver
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Address
94648
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Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
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Country
94648
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New Zealand
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Phone
94648
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+64 78554917
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Fax
94648
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Email
94648
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is to respect the confidentiality of the participants.
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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.
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