Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000608561
Ethics application status
Approved
Date submitted
2/04/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of brain stimulation and strength training on hamstring muscles
Scientific title
The effect of brain stimulation combined with strength training on hamstring muscle strength and structure in recreationally active individuals
Secondary ID [1] 311869 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hamstring muscle architecture 333418 0
Condition category
Condition code
Musculoskeletal 330096 330096 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised control trial to determine the effect of non invasive brain stimulation (transcranial direct current stimulation) on architectural changes resulting from a six-week eccentric training intervention (intervention total: 8 weeks, including pre-, post-testing and familiarisation) on an isokinetic dynamometer. All sessions will be supervised by a researcher.
The tDCS intervention will be 20 minutes and a 2 mA intensity, the eccentric training will include 2 - 4 sets of 4 - 6 repetitions, depending on the week. The tDCS will be applied with the anode over the contralateral motor cortex of the leg being trained and the cathode over the forehead opposite the anode prior to training. The participant comfort to tDCS will be assessed via a 0-10 RPE scale. Eccentric training will be maximal efforts performed on an isokinetic dynomometer.
Total session duration will be 2x 60mins in weeks one and two and 1x 45mins during weeks three to six. The exercise performed will be an eccentric contraction of the hamstrings.
Participants will be randomised into two groups, active-tDCS and sham-tDCS. During the first two weeks of the study, participants will attend the laboratory twice, and once in the latter four weeks. Participants will also attend pre and post training sessions to obtain baseline measures and a familiarisation session, making the full duration of the intervention eight to nine weeks.
Pre and post baseline measures taken will include, hamstring fascicle length taken via ultrasound, active motor threshold taken via transcranial magnetic stimulation and maximal muscle strength. Active motor threshold will also be taken in weeks 2, 4 and 6.
Attendance and training session will be monitored via the universities REDCap system.
Intervention code [1] 328326 0
Treatment: Devices
Comparator / control treatment
Controls will be paired to the invention group via hamstring muscle fascicle length for analysis purposes. The sole difference for the control group is that they will receive sham tDCS compared to active tDCS. All other processes will be the same.
The shame condition will exactly mirror the active condition, except stimulation will only be delivered for the first 90 seconds.
Control group
Placebo

Outcomes
Primary outcome [1] 337853 0
Hamstring (Biceps Femoris long head) muscle architecture
Timepoint [1] 337853 0
baseline and 1 week post intervention (primary timepoint)
Primary outcome [2] 337854 0
participant discomfort
Timepoint [2] 337854 0
Participant discomfort will be measured every 5 minutes (total 4 measures per exposure to tDCS).
Secondary outcome [1] 433473 0
Active motor threshold (AMT)
Timepoint [1] 433473 0
baseline, intervention weeks 2, 4 and 6, 1 week post completion of the intervention.
Secondary outcome [2] 433474 0
Maximal muscle strength
Timepoint [2] 433474 0
baseline, intervention weeks 2, 4 and 6, 1 week post completion of the intervention.

Eligibility
Key inclusion criteria
1. Currently free of any major lower limb injury at the time of testing.
2. Are currently participating in regular recreational physical activity.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have previously suffered a seizure
2. Current or history of neurological diseases (E.g. epilepsy, Parkinson’s, Alzheimer’s, multiple sclerosis, stroke) AND have no family history of neurological disease.
3. Have embedded material in the skull such as metal fragments/plates, cochlear implants, or brain stimulation device.
4. Have sustained a concussion within the past three months.
5. Have sustained a hamstring strain injury (HSI) within the past 36 months.
6. Have never sustained an anterior cruciate ligament (ACL) injury at any point.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on hamstring fascicle length. Participants will be divided into subgroups of two via hamstring fascicle length, one participant will be allocated to the active condition and the other the placebo condition
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power calculations were performed determining that 11 participants per group are required. An ANOVA will be used to determine timepoint and group differences.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316211 0
University
Name [1] 316211 0
Australian Catholic University
Country [1] 316211 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 318397 0
None
Name [1] 318397 0
Address [1] 318397 0
Country [1] 318397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315028 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 315028 0
ResEthics.Manager@acu.edu.au
Ethics committee country [1] 315028 0
Australia
Date submitted for ethics approval [1] 315028 0
06/10/2023
Approval date [1] 315028 0
07/03/2024
Ethics approval number [1] 315028 0
2023-3262HC

Summary
Brief summary
Hamstring strain injuries (HSIs), occurring primarily in the biceps femoris long head, have been shown to lead to an increased likelihood of re-injury. These injuries also lead to decreased muscle activity in eccentric contractions, persistent deficits in muscle architecture (i.e., the internal structure of the muscle) and motor pattern changes. Recent evidence also demonstrates that post injury, inhibition exists at the brain (or cortical) level. This inhibition can lead to reduced strength and changes in muscle architecture that can increase injury risk.

The aim of this project is to investigate the effects of a strength training program combined with active or sham tDCS on cortical inhibition, hamstring strength and biceps femoris long head architecture. Our hypothesis is that muscle fascicle length and hamstring strength will increase more in the active tDCS condition rather than the sham condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133474 0
Mr Connor Lee Dow
Address 133474 0
Australian Catholic University, 115 Victoria Parade, Fitzroy VIC 3065
Country 133474 0
Australia
Phone 133474 0
+61 422 401 377
Fax 133474 0
Email 133474 0
connor.leedow@myacu.edu.au
Contact person for public queries
Name 133475 0
Connor Lee Dow
Address 133475 0
Australian Catholic University, 115 Victoria Parade, Fitzroy VIC 3065
Country 133475 0
Australia
Phone 133475 0
+61 422 401 377
Fax 133475 0
Email 133475 0
connor.leedow@myacu.edu.au
Contact person for scientific queries
Name 133476 0
Connor Lee Dow
Address 133476 0
Australian Catholic University, 115 Victoria Parade, Fitzroy VIC 3065
Country 133476 0
Australia
Phone 133476 0
+61 422 401 377
Fax 133476 0
Email 133476 0
connor.leedow@myacu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data
When will data be available (start and end dates)?
Upon acceptance of the trial to an academic journal, during the 15 year holding time at ACU.
Available to whom?
Other researchers
Available for what types of analyses?
Meta-analysis.
How or where can data be obtained?
Upon request only, data can be made available via ACU Research Bank https://acuresearchbank.acu.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22044Study protocol  connor.leedow@myacu.edu.au
22045Analytic code  connor.leedow@myacu.edu.au Note yet created
22046Statistical analysis plan  connor.leedow@myacu.edu.au
22047Informed consent form  connor.leedow@myacu.edu.au
22048Ethical approval  connor.leedow@myacu.edu.au Application ID: 2023-3262HC
22049Data dictionary  connor.leedow@myacu.edu.au De-identified data will be made available upon req... [More Details]



Results publications and other study-related documents

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