Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001412527
Ethics application status
Approved
Date submitted
13/11/2024
Date registered
29/11/2024
Date last updated
29/11/2024
Date data sharing statement initially provided
29/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of cadence and sex on calf muscle fatigue during the calf raise test
Scientific title
The effects of cadence and sex on the mechanisms of calf muscle fatigue during maximal calf raise tests in healthy young adults from the greater Montreal area
Secondary ID [1] 313371 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle fatigue 335732 0
Musculoskeletal pain 335733 0
Achilles tendon injuries 335734 0
Calf muscle injuries 335735 0
Condition category
Condition code
Musculoskeletal 332296 332296 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 332412 332412 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised crossover trial with repeated measures performed in a laboratory. Participants will be required to attend a single session lasting around 120 to 150 minutes.

The aim of the study is to assess the influence of calf raise cadence (60 beats per minute vs 120 beats per minute) on muscular mechanisms (activity, fatigue, thickness, and oxygenation) in a comparative way between males and females.

Two kinesiology students trained by an expert physiotherapist / researcher (over 15 years experience, over 500 calf raise test administration) will supervise the session. The same kinesiology student will provide all verbal instructions. Sessions will be conducted one-on-one, with only one participant present at a time.

The cadence of the calf raise test will be audible via a metronome, and supervised by the kinesiology students. The 3D motion capture system will enable confirmation of the actual cadence followed by participants following test completion.

Both the 60 and 120 beats per minute conditions will be assessed within the same session, with 40 minutes rest between conditions. Only the dominant leg (leg used to kick a ball) will be tested. Adherence to the calf raise test protocol will be visually monitored throughout the session my the two trained kinesiology students.
Intervention code [1] 329954 0
Treatment: Other
Intervention code [2] 330018 0
Rehabilitation
Comparator / control treatment
The control condition for this trial is the 60 beats per minute calf raise test. Each participant will act as their own control (i.e., repeated measures).
Control group
Active

Outcomes
Primary outcome [1] 339870 0
Muscle activity
Timepoint [1] 339870 0
Start (first 5 repetitions) and end (last 5 repetitions) of the calf raise test, excluding the first 2 and last 2 repetitions (i.e., end point errors)
Primary outcome [2] 339871 0
Muscle fatigue
Timepoint [2] 339871 0
Start (first 5 repetitions) and end (last 5 repetitions) of the calf raise test, excluding the first 2 and last 2 repetitions (i.e., end point errors)
Primary outcome [3] 339872 0
Muscle thickness
Timepoint [3] 339872 0
Before the calf raise test and immediately after the calf raise test to fatigue
Secondary outcome [1] 441704 0
Tissue oxygenation
Timepoint [1] 441704 0
Start (first 5 repetitions) and end (last 5 repetitions) of the calf raise test, excluding the first 2 and last 2 repetitions (i.e., end point errors)
Secondary outcome [2] 441705 0
Calf Raise Test Performance
Timepoint [2] 441705 0
Throughout the Calf Raise Test

Eligibility
Key inclusion criteria
A convenience sample of healthy young adults from the Montreal area. Inclusion criteria are:
1. Ages 18 to 40 years.
2. No health concerns that would inhibit participation
3. Have not performed high intensity exercise within 24 hours of visit.
4. Have not drank alcohol within 24 hours and caffeine within 12 hours before the visit.
5. Have no musculoskeletal or cardiovascular impairments in the 3 months prior to data collection (confirmed by passing the PAR-Q).
6. Willing to provide informed consent to participate.
7. No history of an Achilles tendon rupture.
8. At least moderate physical activity levels on the Short Form International Physical Activity Questionnaire
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals that are older than 40 years or younger than 18 years old, that have health concerns identified using the PAR-Q, that have a history of Achilles tendon rupture, and that present with low levels of physical activity (based on the Short Form International Physical Activity Questionnaire) will be excluded.

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)
Central randomisation before participant recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by sex
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculation was performed using G*Power, with the primary outcome measures as the change in EMG of Medial Gastrocnemius pre-to-post. A repeated measures analysis of variance (ANOVA) with both within (cadence) and between (sex) interaction statistical tests is planned for use. Setting power to 0.80, f effect size to 0.25, alpha-level to 0.05, correlations amongst repeated measures to 0.5, and assuming spericity indicates that a total sample of 34 participants (50% female) is required. These assumptions were made based on statistical measures found in Youdas et al. (2007, 10.1519/00124278-200702000-00020) and Yoon et al. (2022, 10.1139/apnm-2021-0664)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
14/03/2025
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 26725 0
Canada
State/province [1] 26725 0
Quebec

Funding & Sponsors
Funding source category [1] 317811 0
University
Name [1] 317811 0
McGill University
Country [1] 317811 0
Canada
Funding source category [2] 317812 0
University
Name [2] 317812 0
University of Waikato
Country [2] 317812 0
New Zealand
Primary sponsor type
University
Name
McGill University
Address
Country
Canada
Secondary sponsor category [1] 320141 0
University
Name [1] 320141 0
University of Waikato
Address [1] 320141 0
Country [1] 320141 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316494 0
McGill University Research Ethics Board
Ethics committee address [1] 316494 0
Ethics committee country [1] 316494 0
Canada
Date submitted for ethics approval [1] 316494 0
30/04/2024
Approval date [1] 316494 0
05/08/2024
Ethics approval number [1] 316494 0
24-04-116

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

Contacts
Principal investigator
Name 138078 0
A/Prof Kim Hebert-Losier
Address 138078 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 138078 0
New Zealand
Phone 138078 0
+64 22 062 0781
Fax 138078 0
Email 138078 0
[email protected]
Contact person for public queries
Name 138079 0
Kim Hebert-Losier
Address 138079 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 138079 0
New Zealand
Phone 138079 0
+64 22 062 0781
Fax 138079 0
Email 138079 0
[email protected]
Contact person for scientific queries
Name 138080 0
Kim Hebert-Losier
Address 138080 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 138080 0
New Zealand
Phone 138080 0
+64 22 062 0781
Fax 138080 0
Email 138080 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participants are given the right to consent (or not) to the sharing of de-identified data to be used for future, related research. Given the status of their consent is unknown, we cannot confirm if IPD will be made available.



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.