Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001646134
Ethics application status
Approved
Date submitted
4/11/2019
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of High Intensity, Short Duration Trampolining on Human Physiology
Scientific title
The Effect of High Intensity, Short Duration Trampolining on Human Physiology in Healthy Volunteers
Secondary ID [1] 299700 0
None
Universal Trial Number (UTN)
U1111-1242-9115
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Healthy Physiology 315050 0
Condition category
Condition code
Musculoskeletal 313382 313382 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention duration was 8 weeks. The participants were required to complete 100 continuous bounces on a trampoline at the maximum intensity they were capable of. The trampoline was located in a laboratory at the University of Canterbury. For the participant to be considered compliant with the protocol, they were required to complete an average of 3 bounce sessions per week across the intervention, with a weekly maximum of 5 bounce sessions. The total bounce height and number of bounces was recorded for each jump session and tracked across the intervention for each participant. This was recorded using TGOMA software, which a series of accelerometers built into the trampoline, which is capable of detecting time of flight of the participant and therefore able to work out the participant's bounce height.
Intervention code [1] 315963 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321864 0
Change in V02max test. This was measured using a k5 breath by breath analyser and an athlete led adaptation of the bruce protocol on a treadmill.
Timepoint [1] 321864 0
4 and 8 weeks post commencement of the intervention
Secondary outcome [1] 376523 0
Change in vertical jump. This was measured using a Vertec.
Timepoint [1] 376523 0
4 and 8 weeks post-commencement of the intervention
Secondary outcome [2] 376989 0
Mass this was measured using a digital scale with BIA
Timepoint [2] 376989 0
4 and 8 Weeks post-commencement of intervention
Secondary outcome [3] 376990 0
Fat Mass this was measured using a digital scale with BIA
Timepoint [3] 376990 0
4 and 8 Weeks post-commencement of intervention
Secondary outcome [4] 376991 0
Muscle Mass this was measured using a digital scale with BIA
Timepoint [4] 376991 0
4 and 8 Weeks post-commencement of intervention
Secondary outcome [5] 376992 0
Blood Pressure this was measured using a digital bench-top sphygmomanometer
Timepoint [5] 376992 0
4 and 8 Weeks post-commencement of intervention
Secondary outcome [6] 376993 0
Blood Cholesterol (total)
Timepoint [6] 376993 0
4 and 8 Weeks post-commencement of intervention
Secondary outcome [7] 376994 0
Blood Glucose
Timepoint [7] 376994 0
4 and 8 Weeks post-commencement of intervention

Eligibility
Key inclusion criteria
The general population was utilised with no key inclusion criteria.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria were health risks that contraindicate exercise testing, diseases that are associated with loss of balance, as well as the presence of infections, injuries or an existing drug treatment that could potentially limit physical performance.

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
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
1/02/2019
Date of last data collection
Anticipated
Actual
1/05/2019
Sample size
Target
30
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 22005 0
New Zealand
State/province [1] 22005 0
Canterbury

Funding & Sponsors
Funding source category [1] 304175 0
Government body
Name [1] 304175 0
Callaghan Innovation
Country [1] 304175 0
New Zealand
Primary sponsor type
Government body
Name
Callaghan Innovation
Address
5 Sheffield Cres, Burnside, Christchurch 8053
Country
New Zealand
Secondary sponsor category [1] 304405 0
None
Name [1] 304405 0
None
Address [1] 304405 0
None
Country [1] 304405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304647 0
University of Canterbury Ethics Board
Ethics committee address [1] 304647 0
Ethics committee country [1] 304647 0
New Zealand
Date submitted for ethics approval [1] 304647 0
Approval date [1] 304647 0
01/07/2018
Ethics approval number [1] 304647 0

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

Contacts
Principal investigator
Name 97714 0
Mr Tane Clement
Address 97714 0
University of Canterbury, 20 Kirkwood Ave, Upper Riccarton, Christchurch 8041
Country 97714 0
New Zealand
Phone 97714 0
+64 0284073001
Fax 97714 0
Email 97714 0
[email protected]
Contact person for public queries
Name 97715 0
Tane Clement
Address 97715 0
University of Canterbury, 20 Kirkwood Ave, Upper Riccarton, Christchurch 8041
Country 97715 0
New Zealand
Phone 97715 0
+64 0284073001
Fax 97715 0
Email 97715 0
[email protected]
Contact person for scientific queries
Name 97716 0
Tane Clement
Address 97716 0
University of Canterbury, 20 Kirkwood Ave, Upper Riccarton, Christchurch 8041
Country 97716 0
New Zealand
Phone 97716 0
+64 0284073001
Fax 97716 0
Email 97716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.