Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000664943
Ethics application status
Approved
Date submitted
24/06/2011
Date registered
30/06/2011
Date last updated
30/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Training produces substantial improvements in muscle strength, grip strength and range of motion (ROM) of the dominant arm in wheelchair basketball (WCB) players
Scientific title
Among male wheelchair basketball players does strength training improve shoulder flexion strength?
Secondary ID [1] 262377 0
Nil
Universal Trial Number (UTN)
U1111-1122-1703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injuries 268082 0
wheelchair basketball strength of upper extremity 268083 0
wheelchair basketball ROM of upper extremity 268102 0
Condition category
Condition code
Neurological 268231 268231 0 0
Other neurological disorders
Musculoskeletal 268232 268232 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The frequency of sessions was 3 times / week for 10 weeks
a) upper body weight training; b) the duration of each session, was 45 minutes; c) the volume of sessions, was 3 sets of 10 repetitions for 10 different exercises; d) the intensity of sessions, was 60-70% 1-RM; and e) the mode of administration, was small group sessions supervised by a sport therapist.
Intervention code [1] 266771 0
Rehabilitation
Intervention code [2] 266772 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 268968 0
Shoulder flexion strength > 10 Newtons
using Lafayette Manual Muscle Test System (MMT)
Timepoint [1] 268968 0
Baseline and after 10 weeks
Primary outcome [2] 268969 0
Shoulder internal rotation strength > 10 Newtons
using Lafayette Manual Muscle Test System (MMT)
Timepoint [2] 268969 0
Baseline and after 10 weeks
Primary outcome [3] 268970 0
Wrist flexion strength > 10 Newtons
using Lafayette Manual Muscle Test System (MMT)
Timepoint [3] 268970 0
Baseline and after 10 weeks
Secondary outcome [1] 276727 0
Wrist flexion - extension ROM
using a double arm goniometer based on the standardized measurement procedure in physical therapy
Timepoint [1] 276727 0
Baseline and after 10 weeks
Secondary outcome [2] 276728 0
Grip strength 2nd handle position> 5 lbs
using Jamar Hydraulic Hand Dynamometer
Timepoint [2] 276728 0
Baseline and after 10 weeks

Eligibility
Key inclusion criteria
age 20-45 years
at least 2 years of WCB training
Minimum age
20 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. associated lesions of other structures of the shoulder, elbow and wrist joints
2. neurological disease of upper limb

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The procedure for enrolling a subject was
central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 3628 0
Greece
State/province [1] 3628 0

Funding & Sponsors
Funding source category [1] 267254 0
University
Name [1] 267254 0
Department of Physical Education and Sport Science / Aristotle University of Thessalonica
Country [1] 267254 0
Greece
Primary sponsor type
Individual
Name
Konstantinos Vathrakokoilis
Address
PhD - Department of Physical Education and Sport Science
Aristotle University Thessalonica
Pavlou Mela 1, 54621
Thessaloniki
Country
Greece
Secondary sponsor category [1] 266319 0
Individual
Name [1] 266319 0
Athanasios Kitsios
Address [1] 266319 0
Assistant Professor
Department of Physical Education and Sport Science
Aristotle University Thessalonica
Demou Tseliou 8, 54454
Thessaloniki
Country [1] 266319 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269296 0
Aristotle University Presidents Committee on Ethical Consideration in Human Experimentation
Ethics committee address [1] 269296 0
Ethics committee country [1] 269296 0
Greece
Date submitted for ethics approval [1] 269296 0
Approval date [1] 269296 0
23/06/2011
Ethics approval number [1] 269296 0
39879/2011

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

Contacts
Principal investigator
Name 32746 0
Address 32746 0
Country 32746 0
Phone 32746 0
Fax 32746 0
Email 32746 0
Contact person for public queries
Name 15993 0
Konstantinos Vathrakokoilis
Address 15993 0
Aristotle University of Thesalonica
Pavlou Mela 1,
P.C. 54621,
Thessaloniki
Country 15993 0
Greece
Phone 15993 0
+30 6930 450 450
Fax 15993 0
+30 2310 240 860
Email 15993 0
[email protected]
Contact person for scientific queries
Name 6921 0
Konstantinos Vathrakokoilis
Address 6921 0
Aristotle University Thesalonica
Pavlou Mela 1,
P.C. 54621,
Thessaloniki
Country 6921 0
Greece
Phone 6921 0
+30 6930 450 450
Fax 6921 0
+30 2310 240 860
Email 6921 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.