Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001770156p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2019
Date registered
13/12/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Trampolining on Incontinence and Bone Density
Scientific title
The Effect of Trampolining on Incontinence and Bone Density Amongst Parous Women: A Pilot Study
Secondary ID [1] 299806 0
None
Universal Trial Number (UTN)
U1111-1239-5933
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incontinence 315199 0
Osteopenia 315249 0
Condition category
Condition code
Musculoskeletal 313515 313515 0 0
Normal musculoskeletal and cartilage development and function
Renal and Urogenital 313860 313860 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Uncontrolled Intervention Trial: PILOT
Pre and Post Tests (Completed the week prior and the week post-intervention)
First, the questionnaires will be given to the participant (incontinence diagnosis, incontinence severity, physical activity questionnaire, diet questionnaire). Then measures of body composition (mass, muscle mass, fat mass) and fitness (V02max) will be taken. Body composition will then be assessed using a bio-impedance scanner. This assesses muscle mass and fat mass by sending an electrical signal through the body. The procedure is painless and non-invasive and takes less than 5 minutes. V02max will be assessed by using a variant of the Bruce protocol (athlete-led) while wearing a gas analyser which collects samples of the participant’s breath. The participant will begin at a walking pace (approx. 8km/hr). At the top of every minute, the participant will be asked if they’re comfortable with the speed being increased (by 1km/hr). The speed will be increased every minute until the participant indicates they are no longer comfortable with the speed increasing. At this stage, the gradient of the treadmill will be increased by 1% every minute. The participant can choose to stop at any time, the test will also be stopped if the participant reaches V02max. The test takes anywhere from 5-15 minutes, depending on the fitness level of the participant.

The sessions for the DXA scan and perineometry will be booked that same day at a time convenient to the participant, but prior to the beginning of the intervention.
A DXA (dual x-ray absorptiometry) scan is a test to assess bone density. It generally takes 10-20 minutes and is painless. The participant will be asked to lie on an open table and try to stay still for the duration of the scan. This will be completed at Pacific Radiology, Riccarton, Christchurch.
Perineometry involves a perineometer being inserted into the participant’s vagina. The participant will then be asked to contract their pelvic floor as hard as possible and maintain that contraction for ten seconds. This will be repeated three times with the peak contraction measured. This procedure will be performed by a registered physiotherapist at Freedom Health, Papanui, Christchurch.
Each of these tests will be repeated at the completion of the intervention. All data collected from these measures will only be available to either the primary investigator or the health professional who collected the data. Once collected all data will be stored anonymously on private, password-protected servers.

Intervention
A Springfree trampoline will be delivered to the participant’s house and assembled. At a time convenient to the participant, the lead researcher will travel to the participant’s house to go through the intervention procedure, with the participant, to ensure the protocol is being performed correctly.

The intervention procedure involves bouncing on the trampoline a minimum of three times per week, up to a maximum of five times per week, for 100 bounces at the maximum height the participant is capable of while remaining continent. This trampoline will be TGOMA-enabled. TGOMA (Take Gaming Outside and Make it Active) is a product designed by Springfree, which is a trampoline with accelerometers built into the trampolining mat. These accelerometers can calculate the time of flight of a person bouncing on the trampoline and from this data can work out the bounce height and track the number of bounces. An application on TGOMA called “Powerpath” will be utilised for the intervention. Powerpath tracks the participant’s bounce height for each bouncing session. It then shows the participant’s previous best bounce and displays a goal height for the participant to aim to beat. This acts to encourage the participant to constantly try to improve. Each bounce session will be monitored using the TGOMA software, where the number of bounces and total bounce height will be measured. Adherence to the protocol is also recorded using TGOMA data, as each session is recorded separately.
Intervention code [1] 316079 0
Rehabilitation
Intervention code [2] 316324 0
Treatment: Other
Intervention code [3] 316325 0
Prevention
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322011 0
Strength of pelvic floor muscles as assessed by perineometer
Timepoint [1] 322011 0
12 weeks post-intervention
Primary outcome [2] 322012 0
Change in Bone Mineral Density as assessed by dual energy X-ray absorptiometry (DXA scan)
Timepoint [2] 322012 0
12 Weeks Post-Intervention
Primary outcome [3] 322291 0
Change in rate of incontinence assessed using a questionnaire (ICIQ-IU)
Timepoint [3] 322291 0
12 Weeks Post-Intervention
Secondary outcome [1] 376987 0
Change in Aerobic Capacity (V02max) as assessed by spirometry. This will be assessed using a modified version of the Bruce protocol (Athlete-led) on a treadmill.
Timepoint [1] 376987 0
12 Weeks post-intervention
Secondary outcome [2] 376988 0
Change in muscle mass as assessed by bio-electrical impedance analysis
Timepoint [2] 376988 0
12 Weeks post-intervention
Secondary outcome [3] 377866 0
Change in fat mass as assessed by bio-electrical impedance analysis
Timepoint [3] 377866 0
12 weeks post-intervention
Secondary outcome [4] 377867 0
Change in mass as assessed by bio-electrical impedance analysis
Timepoint [4] 377867 0
12 Weeks post-intervention

Eligibility
Key inclusion criteria
Women must have given birth
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/03/2020
Actual
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
31/05/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 22123 0
New Zealand
State/province [1] 22123 0
Canterbury

Funding & Sponsors
Funding source category [1] 304267 0
Commercial sector/Industry
Name [1] 304267 0
Springfree Trampolines
Country [1] 304267 0
New Zealand
Primary sponsor type
Government body
Name
Callaghan Innovation institute
Address
5 Sheffield Crescent, Burnside, Christchurch 8053
Country
New Zealand
Secondary sponsor category [1] 304555 0
None
Name [1] 304555 0
Address [1] 304555 0
Country [1] 304555 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304722 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 304722 0
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304722 0
New Zealand
Date submitted for ethics approval [1] 304722 0
18/11/2019
Approval date [1] 304722 0
Ethics approval number [1] 304722 0

Summary
Brief summary
The project hypothesizes that due to the co-contraction of the pelvic floor during exercise, trampolining will positively affect both the rate of incontinence and bone density amongst parous women.

Parous women will be recruited to the project through advertising and word of mouth around Christchurch Women's Hospital. The intervention protocol will last for 12 weeks. It will involve the participant completing 100 bounces on a trampoline, up to x5/week, at their home, at the highest possible intensity they can, without loss of bladder control. Over time, the intensity of the bouncing regime (the height the participants bounce to) will increase. All bouncing activity will be tracked through the use of the TGOMA software. This software records jump height and number of jumps performed, using an application called Powerpath. Powerpath displays the user's current bounce height and sets a goal height for the participant to jump higher than. It also shows the best previous effort of the participant. This software will be used to track both adherence (how often they are bouncing during the intervention) and compliance (the intensity at which they are bouncing. Measurement of the variables will be taken at 0 and 12 weeks. This will include assessment of body composition, fitness, bone density and pelvic floor strength.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98002 0
Mr Tane Clement
Address 98002 0
University of Canterbury, 20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 98002 0
New Zealand
Phone 98002 0
+64 033667001
Fax 98002 0
Email 98002 0
[email protected]
Contact person for public queries
Name 98003 0
Mr Tane Clement
Address 98003 0
University of Canterbury, 20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 98003 0
New Zealand
Phone 98003 0
+64 033667001
Fax 98003 0
Email 98003 0
[email protected]
Contact person for scientific queries
Name 98004 0
Mr Tane Clement
Address 98004 0
University of Canterbury, 20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
Country 98004 0
New Zealand
Phone 98004 0
+64 033667001
Fax 98004 0
Email 98004 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5745Study protocol    378736-(Uploaded-19-11-2019-06-13-56)-Study-related document.docx
5747Informed consent form    378736-(Uploaded-19-11-2019-06-14-24)-Study-related document.doc



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.