Trial Review

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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
Scientific title
The effect of a pneumatic compression device on recovery in wheelchair basketball players
Secondary ID [1] 298641 0
None
Universal Trial Number (UTN)
U1111-1235-1150
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 313569 0
Amputee 313570 0
Spina Bifida 313571 0
Cerebral palsy 313572 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312004 312004 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 314946 0
Treatment: Devices
Comparator / control treatment
The participants will not use the pneumatic compression device following the training session.
Control group
Active

Outcomes
Primary outcome [1] 320616 0
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
Timepoint [1] 320616 0
Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
Primary outcome [2] 320617 0
Repeated wheelchair sprints
3 x 15 metre sprints
45 sec rest in between.
Timepoint [2] 320617 0
Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
Primary outcome [3] 320618 0
Blood lactate - using finger prick test.
Timepoint [3] 320618 0
Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
Secondary outcome [1] 372214 0
Muscle soreness - measured using algometer that measures amount of pressure within the muscle
Timepoint [1] 372214 0
Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves
Secondary outcome [2] 372215 0
Hand grip strength - measured using dynamometer
Timepoint [2] 372215 0
Performed three times. Immediately before high intensity session,
5 minutes after high intensity session
immediately following use of pneumatic compression sleeves

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 21662 0
New Zealand
State/province [1] 21662 0

Funding & Sponsors
Funding source category [1] 303182 0
University
Name [1] 303182 0
University of Waikato
Country [1] 303182 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Knighton Road
Hillcrest
Hamilton
3216
Country
New Zealand
Secondary sponsor category [1] 303194 0
None
Name [1] 303194 0
Address [1] 303194 0
Country [1] 303194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303744 0
Health and Disability Ethics Committees
Ethics committee address [1] 303744 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 303744 0
New Zealand
Date submitted for ethics approval [1] 303744 0
Approval date [1] 303744 0
25/06/2019
Ethics approval number [1] 303744 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94646 0
Miss Alison Oliver
Address 94646 0
Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
Country 94646 0
New Zealand
Phone 94646 0
+64 78554917
Fax 94646 0
Email 94646 0
aeo4@students.waikato.ac.nz
Contact person for public queries
Name 94647 0
Miss Alison Oliver
Address 94647 0
Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
Country 94647 0
New Zealand
Phone 94647 0
+64 78554917
Fax 94647 0
Email 94647 0
aeo4@students.waikato.ac.nz
Contact person for scientific queries
Name 94648 0
Miss Alison Oliver
Address 94648 0
Faculty of Health Sport and Human Performance
University of Waikato
Knighton Road
Hillcrest
Hamilton 3216
Country 94648 0
New Zealand
Phone 94648 0
+64 78554917
Fax 94648 0
Email 94648 0
aeo4@students.waikato.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is to respect the confidentiality of the participants.


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.