Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000834257
Ethics application status
Approved
Date submitted
18/01/2018
Date registered
16/05/2018
Date last updated
16/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of sport climbing on physical ability of people with intellectual disabilities.
Scientific title
The effect of sport climbing on physical ability of people with intellectual disabilities.
Secondary ID [1] 292601 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intellectual disability


 304280 0
physical ability
 304281 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303627 303627 0 0
Physiotherapy
Mental Health 303628 303628 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group members take part in climbing activities for the period of 12 weeks.
The participants undertook climbing twice a week under the supervision of a climbing instructor in a sports climbing hall with a professional climbing wall.
The activities take 60 minutes and consist of a general warm-up, climbing training and a cool-down part. Every group contained 10 - 11 participants.

The effectiveness of the exercise programme will be assessed based on testing the physical ability of the participants.
All the participants' motor ability will be tested using Eurofit Special and Eurofit tests, before and after the programme.
The balance of participants will be additionally tested on the BTS P-walk bar-resistant platform as well as using FRT – Functional Reach Test and Single Leg Stance Test.

All tests will be carried out by one researcher. The participants will also be requested to complete - with the help of a psychologist - a questionnaire prepared by the researcher testing their attitude towards physical activity and their attitude towards climbing activities.
Intervention code [1] 298813 0
Treatment: Other
Intervention code [2] 301154 0
Rehabilitation
Comparator / control treatment
The controls will take part in obligatory PE classes whose plans will consist of general fitness exercises (aerobic exercises of moderateintensity as movement games and activities).

Control group
Active

Outcomes
Primary outcome [1] 302981 0
Influence of sports climbing activities on static and dynamic balance.
The balance of participants will be additionally tested on the BTS P-walk bar-resistant platform(distributed by Technomex Ltd.) as well as using FRT – Functional Reach Test and Single Leg Stance Test.
Is this a composite primary outcome
Timepoint [1] 302981 0
At baseline (test 1), immediately after 12 weeks (test 2)
Primary outcome [2] 302982 0
Influence of sports climbing activities on strength.
All the participants' motor ability will be tested using Eurofit Special and Eurofit tests, before and after the programme.
Timepoint [2] 302982 0
At baseline (test 1), immediately after 12 weeks (test 2)
Primary outcome [3] 305831 0
Influence of sports climbing activities on speed.
All the participants' motor ability will be tested using Eurofit Special before and after the programme.
Timepoint [3] 305831 0
At baseline (test 1), immediately after 12 weeks (test 2)
Secondary outcome [1] 337619 0
Potential effectiveness of sports climbing activities as a form of physiotherapy.
Questionnaire designed specifically for the purpose of the study.
Timepoint [1] 337619 0
At baseline (test 1), immediately after 12 weeks (test 2),

Eligibility
Key inclusion criteria
diagnosed mild to moderate intellectual disability
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
epilepsy
accompanying circulatory condition
medical contraindications to particpating in sports activities

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
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/01/2017
Date of last participant enrolment
Anticipated
Actual
31/01/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
80
Accrual to date
Final
73
Recruitment outside Australia
Country [1] 9492 0
Poland
State/province [1] 9492 0

Funding & Sponsors
Funding source category [1] 297189 0
Government body
Name [1] 297189 0
Urzad Miasta Tarnowa
Country [1] 297189 0
Poland
Primary sponsor type
University
Name
State Higher Vocational School in Tarnow
Address
Mickiewicza 8
33-100 Tarnów
Country
Poland
Secondary sponsor category [1] 297533 0
None
Name [1] 297533 0
Address [1] 297533 0
Country [1] 297533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298346 0
Bioethic Committee of Regional Medical Chamber
Ethics committee address [1] 298346 0
Ethics committee country [1] 298346 0
Poland
Date submitted for ethics approval [1] 298346 0
12/01/2017
Approval date [1] 298346 0
23/02/2017
Ethics approval number [1] 298346 0
1/0177/2017

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

Contacts
Principal investigator
Name 76786 0
Mrs Marta Bibro
Address 76786 0
State Higher Vocational School in Tarnów ul. Mickiewicza 8, 33-100 Tarnów
Country 76786 0
Poland
Phone 76786 0
+4814 63 16 579
Fax 76786 0
004814 63 16 600
Email 76786 0
[email protected]
Contact person for public queries
Name 76787 0
Marta Bibro
Address 76787 0
State Higher Vocational School in Tarnów ul. Mickiewicza 8, 33-100 Tarnów
Country 76787 0
Poland
Phone 76787 0
+4814 63 16 579
Fax 76787 0
004814 63 16 600
Email 76787 0
[email protected]
Contact person for scientific queries
Name 76788 0
Marta Bibro
Address 76788 0
State Higher Vocational School in Tarnów ul. Mickiewicza 8, 33-100 Tarnów
Country 76788 0
Poland
Phone 76788 0
+4814 63 16 579
Fax 76788 0
004814 63 16 600
Email 76788 0
[email protected]

No information has been provided regarding IPD availability


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.