Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001761156
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
11/12/2019
Date last updated
14/02/2020
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of weekly Slackline training on human balance.
Scientific title
Effect of 15- minutes Slackline training sessions on balance performance in healthy volunteer
Secondary ID [1] 299774 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
balance performance 315141 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313458 313458 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of the study is to verify if Slackline training sessions could be helpful in improving balance in healthy young people. The project will allow to check the impact of Slackline training on changes in the balance in students practicing moderate-intensity physical activity.


The research will be led by two university research student who will work under the substantive support of a university researcher. Training will be conducted in the park at the university

For the study will be recruited 28 students of the Opole University of Technology declaring that they are healthy and do not play any sport professionally. Each subject will undergo initial and final examinations. Test will be carried out using two selected protocols available on the Balance Master® platform.
- Tandem Walk Test- Specifies the gait characteristics of the patient crossing the measurement platform using tandem walk
- Modified Clinical Test of the Sensory Interaction on Balance- Specifies the postural swing speed in 4 different conditions:
1) patient is standing on a stable ground with open eyes
2) patient is standing on a stable ground with closed eyes
3) patient is standing on an unstable ground with open eyes
4) patient is standing on an unstable ground with closed eyes
The subjects will be randomly assigned to 2 groups.

First group will participate in 5 days intervention. Trainings will be held 5 times a week (from Monday to Friday) and each session will last 15 minutes. The task will be to maintain balance crossing a 5 cm wide and 9m length nylon tape stretched at a height of 50cm. Gibbon CLASSIC LINE 15M will be used for slackline training. The most versatile tape offered by Gibbon Slacklines. The subjects' task will be to maintain balance as long as possible and cover the longest possible distance. Each fall will result in a return to the beginning of the tape. Throughout the training, heart rate will be monitored by the Polar OH1optical heart rate sensor. Polar OH1 is a monitor armband that combines versatility, comfort and simplicity.
Second group is the control group that will only undergo initial and final tests.
Intervention code [1] 316030 0
Lifestyle
Intervention code [2] 316280 0
Treatment: Other
Comparator / control treatment
The control group will only undergo initial and final tests at the same time as the active training group. Subjects will maintain their weekly physical activity at the same level
Control group
Active

Outcomes
Primary outcome [1] 321949 0
Balance performance assessed using Tandem Walk Test and Modified Clinical Test of the Sensory Interaction on Balance test
Timepoint [1] 321949 0
1. baseline - Initial assessment of the participants 2. Final assessment of participants after 5 days of Slackline training
Secondary outcome [1] 376773 0
Physical activity level assessed using SenseWear Armband. The devices allow to evaluate energy expenditure expressed in MET and kilocalories, additionally monitor such parameters as: total number of steps, level and duration of physical activity, duration of sleep, rest period. All component results allow to determine one composite outcome.
Timepoint [1] 376773 0
1. baseline - Initial assessment of the participants 2. Final assessment of participants after 5 days of Slackline training
Secondary outcome [2] 376774 0
Heart rate variability assessed using Polar OH1 optical heart rate sensor. Polar OH1 is a monitor armband that combines versatility, comfort and simplicity
Timepoint [2] 376774 0
1. baseline - Initial assessment of the participants 2. Final assessment of participants after 5 days of Slackline training

Eligibility
Key inclusion criteria
The criteria for inclusion in the study will be:
1. Female and male
2. Aged 19-26 years,
3. Not practicing regular physical activity and not practicing sports more than 30 minutes per week.
Minimum age
19 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included diseases and injuries of the locomotor system impairing the function of locomotion, surgical procedures, diagnosed chronic disease, hospitalization within the last 24 months before the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis will be carried out using STATISTICA 13 software. It is planned to determine the distribution of variables. In the absence of Fundamentals reject the hypothesis of a normal distribution is performed ANOVA with Tukey's test reproducible measurements do post-hoc, and with the rejection of the hypothesis of a normal distribution will be done Friedman ANOVA. The statistical significance level was accepted at p<0.05 for all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/12/2019
Actual
13/01/2020
Date of last participant enrolment
Anticipated
Actual
31/01/2020
Date of last data collection
Anticipated
10/02/2020
Actual
10/02/2020
Sample size
Target
28
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 22041 0
Poland
State/province [1] 22041 0
Opole

Funding & Sponsors
Funding source category [1] 304239 0
Other Collaborative groups
Name [1] 304239 0
Descartes’ Error Student scientific circle
Country [1] 304239 0
Poland
Primary sponsor type
University
Name
Opole University of Technology
Address
Opole University of Technology, Proszkowska 76 Street, 45-758 Opole, Poland
Country
Poland
Secondary sponsor category [1] 304478 0
None
Name [1] 304478 0
Address [1] 304478 0
Country [1] 304478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304698 0
Bioethical commission Opole Medical Chamber in Opole
Ethics committee address [1] 304698 0
Ethics committee country [1] 304698 0
Poland
Date submitted for ethics approval [1] 304698 0
20/05/2019
Approval date [1] 304698 0
07/06/2019
Ethics approval number [1] 304698 0
289/07.06.2019

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

Contacts
Principal investigator
Name 97910 0
Dr Sebastian Rutkowski
Address 97910 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 97910 0
Poland
Phone 97910 0
+48507027792
Fax 97910 0
Email 97910 0
[email protected]
Contact person for public queries
Name 97911 0
Sebastian Rutkowski
Address 97911 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 97911 0
Poland
Phone 97911 0
+48507027792
Fax 97911 0
Email 97911 0
[email protected]
Contact person for scientific queries
Name 97912 0
Sebastian Rutkowski
Address 97912 0
Opole University of Technology 76 Proszkowska Street 45-758 Opole
Country 97912 0
Poland
Phone 97912 0
+48507027792
Fax 97912 0
Email 97912 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data that underline the results reported in study

What types of analyses could be done with individual participant data?
• To achieve aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following article publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Proposal should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement

Are there extra considerations when requesting access to individual participant data?
No


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.