Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000753550
Ethics application status
Approved
Date submitted
24/05/2024
Date registered
18/06/2024
Date last updated
18/06/2024
Date data sharing statement initially provided
18/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Why do some people respond better to advanced footwear technology, but others do not?
Scientific title
A randomised crossover trial in healthy adult runners to examine running economy responses and influence of plantarflexion fatigue towards advanced footwear technology
Secondary ID [1] 312110 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular fitness 333750 0
Lower extremity biomechanics 333751 0
Musculoskeletal pain 333752 0
Condition category
Condition code
Cardiovascular 330434 330434 0 0
Normal development and function of the cardiovascular system
Musculoskeletal 330435 330435 0 0
Normal musculoskeletal and cartilage development and function

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 two sessions within a week, where each session should be around 90 to 120 minutes each. The aim of the study is two fold: 1) identify whether intrinsic variables (namely participant characteristics, plantarflexion function, and running biomechanics) contribute to running economy responses in advanced footwear technology. Second, we aim to identify whether plantarflexion fatigue influences the running economy responses to advanced footwear technology.

Session one. After informed consent and baseline data collection (height, mass, running participation, injury history, own shoe characteristics), participants will complete a series of standardised assessments:

These measurements include: baseline information like age, height, mass, and running experience; foot width, foot length, and foot height while standing and sitting; Achilles tendon moment arm length and plantarflexion gear ratio; Foot Posture Index 6; triceps surae muscle, plantar fascia, and Achilles tendon stiffness; 1st metatarsophalangeal joint range of motion in standing; plantarflexion isometric strength in standing and sitting, weighted power, and strength-endurance; ankle inversion, ankle eversion, and toe flexor isometric strength; vertical hopping stiffness; and VO2peak running on a treadmill in their own shoes. The incremental VO2peak test will be conducted at the end of the session running on a treadmill using an incremental speed protocol. The starting speed will be individualised in the aim to have the test finish within 10-15 minutes. The VO2peak test will set the speed for running during the main intervention: running in a control and running in a shoe with advanced footwear technology in session 2.

Session 2 is the main experimental session as running economy tests will be performed in an advanced footwear technology (AFT) shoe (Salomon S/Lab Phantasm 2) and a control shoe (Salomon Aero Glide 2). These data will be used to determine the running economy responses of runners to advance footwear technology.

After rating their perceived calf muscle soreness and fatigue on 100 mm visual analog scale (VAS), participants will warm up for 6 minutes running on a treadmill in their own shoes at a self-selected speed for the first 3 minutes and at 70% of the speed founf to elicit VO2peak for the last 3 minutes. Participants will complete shoe visual analogue scale measures and baseline lactate will be recorded. Baseline weighted plantarflexion power will be assessed. Participants will then complete 4x 6 minute running economy tests using the experimental shoes. The ordering of the shoes used will be either AFT, Control, Control, AFT or Control, AFT, AFT, Control. Running speed on the treadmill will be 70% of the speed found to elicit VO2max in session 1. During each running trial, footstrike patterns and contact and flight time from the right leg will be gathered from 30 seconds of running in the last minute. After each running economy trial, perceptual readings of comfort and running experience, we well as lactate, will be collected while sitting down with shoes removed. Runners will have 5 minutes seated rest between economy trials.

To identify whether plantarflexion fatigue influences running economy responses to AFT, the plantarflexors will be fatigued using dynamic tasks the same day, immediately following the last 5 minutes rest period of the running economy trials. Weighted plantarflexion power will be assessed first (5 seconds), and then participants will complete as many repetitions as possible of concentric-eccentric plantarflexion repetitions on a 10 degree incline (i.e., calf raise test) on the non-dominant and dominant legs until failure. Participants will complete another round of repetitions to fatigue with an additional 30% body mass load until failure, and weighted plantarflexion power will be re-assessed as measure of fatigue. Participants will rate their perceive calf soreness and fatigue on a 100 mm VAS. and participants will complete a further 1x6 minute running economy test immediately after shoes are replaced, either in the order of AFT, Control or Control, AFT. After the first running economy test, the plantarflexion fatiguing procedures will be repeated immediately after lactate recording from the running economy test before assessment of running economy a second time. A final weighted plantarflexion power test will be conducted after the running trial on the dominant leg only.

To assess adherence to the fatigue intervention, videos of the foot will be recorded to determine how many repetitions are completed during the fatigue test. Furthermore, visual analogue scales on perceived soreness and fatigue will be used to monitor reaching subjective perceptions of fatigue. The weighted power test is completed before and after the fatiguing protocol to quantify the level of dynamic fatigue.
Intervention code [1] 328553 0
Treatment: Other
Intervention code [2] 328802 0
Treatment: Devices
Comparator / control treatment
All participants will wear the control shoe (Salomon Aero Glide 2) and the advanced footwear technology shoe (Salomon S/Lab Phantasm 2) to assess running economy responses.

The running economy of participants will be assessed before plantarflexion fatigue (control) and after plantarflexion fatigue (comparator) to identify the influence of plantarflexion fatigue on responses to advanced footwear technology.
Control group
Active

Outcomes
Primary outcome [1] 338184 0
Oxygen consumption (mL/kg/min) from running economy tests
Timepoint [1] 338184 0
Data from the last two minutes of each running economy trial will be used to calculate oxygen consumption
Primary outcome [2] 338280 0
Energy Costs (W/kg) from running economy tests
Timepoint [2] 338280 0
Data from the last two minutes of each running economy trial will be used to calculate oxygen consumption
Primary outcome [3] 338281 0
Energetic Cost of transport (J/kg/m) using a Metabolic cart (Parvo Medic TrueOne), VO2 values will be collected every 15 seconds throughout each running economy trial. Participant will be running at 70% of the speed found at VO2max.
Timepoint [3] 338281 0
Data from the last two minutes of each running economy trial will be used to calculate oxygen consumption
Secondary outcome [1] 434966 0
VAS overall shoe comfort
Timepoint [1] 434966 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [2] 434967 0
VAS overall running experience
Timepoint [2] 434967 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [3] 434968 0
Weighted plantarflexion peak power (W)
Timepoint [3] 434968 0
This will be done at several time points during the experimental trial. Baseline 1 (session 1), Baseline 2 (session 2), Pre Run 1, Post Run 1, Pre Run 2, Post Run 2, Pre Run 3, Post Run 3. Peak plantarflexion power is the PRIMARY OUTCOME to examine fatigue of the plantarflexors.
Secondary outcome [4] 434981 0
Foot strike angle
Timepoint [4] 434981 0
This will be done from the 6 minutes of each running trial.
Secondary outcome [5] 435266 0
VAS Pleasure-Displeasure
Timepoint [5] 435266 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [6] 435269 0
VAS Easier-Harder
Timepoint [6] 435269 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [7] 435276 0
VAS for Performance
Timepoint [7] 435276 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [8] 435277 0
VAS for Injury
Timepoint [8] 435277 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [9] 435278 0
Running Shoe Comfort Assessment Tool
Timepoint [9] 435278 0
Subjective measures will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.

Eligibility
Key inclusion criteria
Participants who are running one or more times per week for at least the last 6 months. Participants who can run for 30 minutes and are not currently or recently injured (within the last month). Participants need to be free from a history of an Achilles tendon rupture.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Runners are excluded if they do not consistently run one or more times per week for at least the last 6 months or can not continually run for 30 minutes. Also if runners are currently or recently injured (in the last month) or have a history of an Achilles tendon rupture, they will also 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)
The allocation of the intervention will not be concealed
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data collection will run for a period of 5-6 months due to time and resource constraints. As many participants as possible will be recruited and tested during this timeframe. Based on the various sample size calculations for the different study aims, 66 participants would be ideal.

To detect a moderate correlation (r = 0.30) using a two-sided test at a 5% significance level (a=0.05) with 80% power (ß=0.20), the required sample size is 85. To detect a large correlation (r = 0.50), the required sample size is 29. To account for potential missing data, a minimum of 32 participants is deemed minimal, with a maximum set to 94.

To detect large effect size differences between two and three functionally distinct groups, a corresponding sample size of 52 and 66 participants is needed (f = 0.4, alpha = 0.05, beta = 0.20). With the above calculations considered, 66 participants would be ideal to meet the aims of our study.

To identify whether intrinsic variables contribute to running economy responses in advanced footwear technology, we will use clustering analysis to identify functional groups of runners (responders, non-responders, negative responders) and then apply ANOVA or t-tests or non-parametric equivalents based on the number of clusters (2 or 3). Effect size differences in means will be computed. We will set a threshold alpha level equal to 0.05. These analysis will be supplemented by correlation analysis.

To identify whether plantarflexion fatigue influences the running economy responses to advanced footwear technology, paired t-tests or non-parametric equivalent will be used comparing the running economy between shoes before plantarflexion fatigue to the running economy difference between shoes after fatigue. Sample size calculations indicate that 34 participants would be sufficient to detect moderate differences pre and post fatigue in paired analyses. Effect size differences in means will be computed. We will set a threshold alpha level equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 26302 0
New Zealand
State/province [1] 26302 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 316468 0
University
Name [1] 316468 0
University of Waikato
Country [1] 316468 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 318643 0
Commercial sector/Industry
Name [1] 318643 0
Salomon
Address [1] 318643 0
Country [1] 318643 0
France
Secondary sponsor category [2] 318781 0
Commercial sector/Industry
Name [2] 318781 0
Université Catholique de Louvain
Address [2] 318781 0
Country [2] 318781 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315257 0
University of Waikato Human Research Ethics Committee (Health)
Ethics committee address [1] 315257 0
Ethics committee country [1] 315257 0
New Zealand
Date submitted for ethics approval [1] 315257 0
26/04/2024
Approval date [1] 315257 0
17/05/2024
Ethics approval number [1] 315257 0
HREC(HECS)2024#11

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

Contacts
Principal investigator
Name 134154 0
A/Prof Kim Hebert-Losier
Address 134154 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 134154 0
New Zealand
Phone 134154 0
+6478379476
Fax 134154 0
Email 134154 0
[email protected]
Contact person for public queries
Name 134155 0
A/Prof Kim Hebert-Losier
Address 134155 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 134155 0
New Zealand
Phone 134155 0
+6478379476
Fax 134155 0
Email 134155 0
[email protected]
Contact person for scientific queries
Name 134156 0
A/Prof Kim Hebert-Losier
Address 134156 0
The University of Waikato, Adams Centre for High Performance 52 Miro Street, Mount Maunganui 3116 Bay of Plenty
Country 134156 0
New Zealand
Phone 134156 0
+6478379476
Fax 134156 0
Email 134156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants de-identified data used in statistical analysis will be shared. Specifically, data will be made openly available in a public repository that issues datasets with DOIs (e.g., open science framework).
When will data be available (start and end dates)?
Data will be made available when data analysis and write-up is completed, and available alongside publication submission. There is no end date to data availability.
Available to whom?
Data will be openly available in a public repository.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Through DOI (e.g., open science framework - to be confirmed and updated in the registry once 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.