Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000752460
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
8/06/2016
Date last updated
16/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Jumper's knee: does exercise decrease pain and increase participation in basketball?
Scientific title
Isometric and isotonic leg extensions program: does either exercise decrease morbidity of patellar tendinopathy in basketball players when performed regularly during a playing season?
Secondary ID [1] 289274 0
None
Universal Trial Number (UTN)
Trial acronym
POST UP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellar tendinopathy 298859 0
Condition category
Condition code
Musculoskeletal 298927 298927 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention exercises will be conducted four times per week at participants usual training session with equipment provided by the investigators. Players can do their exercise before or after training.
The exercise program will be individualised and delivered electronically to participants with exercise prescription software. the repetitions and sets will be consistent in all participants, the weight will be individualised to each participant and to each leg of each participant to account for differences in muscle strength. Participants will record on the software the number of times each week they complete the session and the weights that they use for the exercise session.
The intervention will be offered for the length of the season, this can vary between 6 and 10 months depending on the competition and the country.
Isometric protocol: Participants will complete isometric holds on a leg extension machine. These consist of 5 x 45 second holds at 70% maximum voluntary contraction (MVC) with 2 minutes recovery between holds.
Isotonic protocol: Participants will complete the isotonic exercise on a leg extension machine using established protocols (4 x 8 contractions at 70% MVC). The rest period between sets will be 1 minute.
Intervention code [1] 294823 0
Treatment: Other
Comparator / control treatment
The isotonic group will serve as the control group,
Control group
Active

Outcomes
Primary outcome [1] 298391 0
OSTRC outcome measure. This validated tool measures that includes 4 simple questions,quantifies the impact of overuse injuries on function and is used for all overuse injuries.
Timepoint [1] 298391 0
Monthly for the length of the season, this will vary depending on country and league and will be between 6 and 10 months.
Primary outcome [2] 298393 0
VISA-P that assesses the amount of pain and dysfunction in people with anterior knee pain. The questions are designed to measure symptoms of jumper's knee, but the questionnaire is not diagnostic.
Timepoint [2] 298393 0
Monthly for the length of the season, this will vary depending on country and league and will be between 6 and 10 months.
Primary outcome [3] 298396 0
Participants will complete a global rating of change in knee pain and function on a seven point scale from very much worse to very much better.
Timepoint [3] 298396 0
End of the competitive season that will be between 6 and 10 months after the start of the intervention depending on the competition level and country.
Secondary outcome [1] 324019 0
The change in the amount of patellar tendon pathology will be assessed using UTC tendon imaging.
Timepoint [1] 324019 0
End of the competitive season that will be between 6 and 10 months after the start of the intervention depending on the competition level and country.

Eligibility
Key inclusion criteria
1. Have current or previous patellar tendinopathy
2. Playing basketball at an elite or semi-elite level that will ensure they are training more than 4 times a week.
3. Over 18 years until they are no longer playing at an elite or sub-elite level, this is usually up to 35 years but occasionally players can be older
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient English language ability to understand informed consent and follow study protocol .

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Whole teams will be block randomised to one intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised estimating equation (group and time)
Previous study (van Ark et al 2015) showed improvement with both exercise interventions, to show a difference between exercise interventions with an alpha of .05 and a beta of >8 128 participants will be required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2017
Actual
Date of last participant enrolment
Anticipated
1/09/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment outside Australia
Country [1] 7892 0
United States of America
State/province [1] 7892 0
Wshington DC. Milwaukee, Tulane, Louisiana, New York

Funding & Sponsors
Funding source category [1] 293654 0
Commercial sector/Industry
Name [1] 293654 0
NBA/GE Orthopaedics and Sports Medicine collaboration
Country [1] 293654 0
United States of America
Primary sponsor type
University
Name
La Trobe university
Address
Kingsbury Drive
Bundoora 3086
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 292490 0
None
Name [1] 292490 0
Address [1] 292490 0
Country [1] 292490 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295091 0
La Trobe university Human ethics committee
Ethics committee address [1] 295091 0
Kingsbury Drive
Bundoora
3086 Victoria Australia
Ethics committee country [1] 295091 0
Australia
Date submitted for ethics approval [1] 295091 0
30/05/2016
Approval date [1] 295091 0
14/07/2016
Ethics approval number [1] 295091 0
HEC016-049

Summary
Brief summary
The impact of patellar tendinopathy is underestimated as many athletes continue to participate with pain that affects performance in games and capacity to train. This study aims to determine if we can change the natural history of pain and impaired performance with exercise;

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66086 0
Prof Jill Cook
Address 66086 0
La Trobe University
Kingsbury Drive
Bundoora
3086, Victoria, Australia
Country 66086 0
Australia
Phone 66086 0
+61 3 94792774
Fax 66086 0
Email 66086 0
[email protected]
Contact person for public queries
Name 66087 0
Prof Jill Cook
Address 66087 0
La Trobe University
Kingsbury Drive
Bundoora
3086, Victoria, Australia
Country 66087 0
Australia
Phone 66087 0
+61 3 94792774
Fax 66087 0
Email 66087 0
[email protected]
Contact person for scientific queries
Name 66088 0
Prof Jill Cook
Address 66088 0
La Trobe University
Kingsbury Drive
Bundoora
3086, Victoria, Australia
Country 66088 0
Australia
Phone 66088 0
+61394792774
Fax 66088 0
Email 66088 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
SourceTitleYear of PublicationDOI
EmbaseLocation of anterior knee pain affects load tolerance in isometric single leg knee extension.2022https://dx.doi.org/10.1016/j.jsams.2022.03.010
N.B. These documents automatically identified may not have been verified by the study sponsor.