Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000731695
Ethics application status
Approved
Date submitted
20/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Potential Placebo Effect of Advanced Footwear Technology on Running Economy, Biomechanics and Comfort in Female Recreational Runners
Scientific title
The Potential Placebo Effect of Advanced Footwear Technology on Running Economy, Biomechanics and Comfort in Female Recreational Runners: A Randomised Cross-Over Study
Secondary ID [1] 309919 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular fitness 330392 0
Lower extremity biomechanics 330393 0
Musculoskeletal pain 330394 0
Condition category
Condition code
Cardiovascular 327230 327230 0 0
Normal development and function of the cardiovascular system
Musculoskeletal 327231 327231 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised cross-over study performed in a Biomechanics Laboratory. Participants will attend one session at the University of Waikato, Adams Centre for High Performance that should last no longer than hours with approximately 45 minutes of this spent running. They will run a ten-minute warm-up in their own shoes. Participants will then complete 4 x 6-minute running economy trials in two pairs of Nike ZoomX Vaporfly Next% 2 (each shoe condition are worn twice) in a randomised mirrored sequence on a stationary treadmill at 10 km/h and 1% incline. Between running bouts, participants will rest for 10 minutes in a seated position, taking the shoes off. At the end of the running economy trials, runners will complete a maximal aerobic capacity test in their own shoes.

The order of conditions will be block randomised prior to study commencement by a third party to ensure an equal number of participants starting in each condition, and allocated sequentially to participants upon study enrolment by a single researcher. Participants will either be allocated Shoe A + Shoe B + Shoe B + Shoe A; or Shoe B + Shoe A + Shoe A + Shoe B.

• SHOE A will be described as follows (True): This is a super shoe made to maximise performance. The thick cushiony foam is the best on the market at returning energy so running feels easier. There is also a full-length curved carbon-fibre plate that acts like a spring to propel you forward. The shoe is super light and we know from research this is important to save energy when you run. Athletes wearing these super shoes are breaking world records at every distance. The shoe is worth $400 because of all these advanced technologies.

• SHOE B will be described as follows (false): This is a knock-off of a super shoe. They look almost the same, but they do not have advanced footwear technologies. It is just regular foam and it does not have a carbon fibre plate. Elite athletes would never wear these to race. You can buy a pair of these online for $100. This is our basic control shoe to see how much better the super shoe is.

Participants will be given the above description of each shoe prior to testing. The "knock-off" shoe will be blinded so that participants are unable to tell that they are the same shoe by spray painting the shoe black with a fabric spray.

The data collectors - a Masters of Health, Sport and Human Performance student, and a University of Waikato laboratory technician (12 years of experience) will be giving the participants each shoe prior to the trials, and immediately taking them from the participant at the competition of the trials.

It is vital for the data collectors to reiterate to the participants when changing shoes which shoe is which as we want participants to believe that the super shoe will make their performance better and make running easier.
Intervention code [1] 326349 0
Treatment: Other
Comparator / control treatment
Each participant will be trialling both shoe conditions, acting as their own control. The "knock-off" shoe will be our control shoe condition, as described to participants: "This is our basic control shoe to see how much better the super shoe is."
Control group
Active

Outcomes
Primary outcome [1] 335114 0
Oxygen consumption (mL/kg/min) using a Metabolic cart (Parvo Medic TrueOne), VO2 values will be collected every 15 seconds throughout each running economy trial.
Timepoint [1] 335114 0
The two highest concurrent VO2 values in the final minute of each running economy trial will be averaged and used to calculate oxygen consumption.
Secondary outcome [1] 423098 0
Energetic cost (W/kg) is calculated using Péronnet and Masicotte equation, the VO2 values needed to complete this equation will be gathered using a Metabolic cart (Parvo Medic TrueOne) with values collected every 15 seconds throughout each running economy trial. Digital scales will be used prior to testing to get the participants' weight.
Timepoint [1] 423098 0
The two highest concurrent VO2 values in the final minute of each running economy trial will be averaged and used to calculate energetic cost.
Secondary outcome [2] 423099 0
Energetic cost of transport (J/kg x min) based on the participants' weight and running speed, the VO2 values needed to complete this calculation will be collected every 15 seconds throughout each running economy trial using a Metabolic cart (Parvo Medic TrueOne). Digital scales will be used prior to testing to get the participants' weight. The treadmill used for this study will be standardised to 10 km/h for running economy trials.
Timepoint [2] 423099 0
The two highest concurrent VO2 values in the final minute of each running economy trial will be averaged and used to calculate the energetic cost of transport. Digital scales will be used prior to testing to get the participants' weight. The speed of the
Secondary outcome [3] 423100 0
A 100-point visual analog scale (VAS) related to overall comfort with a negative anchor point on the left end of the scale (0), and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [3] 423100 0
A 12-item visual analog scale related to 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 [4] 423101 0
A 100-point visual analog scale (VAS) related to heel cushioning with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [4] 423101 0
A 12-item visual analog scale related to 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 [5] 423102 0
A 100-point visual analog scale (VAS) related to forefoot cushioning with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [5] 423102 0
A 12-item visual analog scale related to 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] 423103 0
A 100-point visual analog scale (VAS) related to forefoot flexibility with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [6] 423103 0
A 12-item visual analog scale related to 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] 423104 0
A 100-point visual analog scale (VAS) related to shoe stability with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [7] 423104 0
A 12-item visual analog scale related to 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] 423218 0
A 100-point visual analog scale (VAS) related to shoe stiffness with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [8] 423218 0
A 12-item visual analog scale related to 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] 423577 0
A 100-point visual analog scale (VAS) related to the number of technical and supporting features of the shoe with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [9] 423577 0
A 12-item visual analog scale related to 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 [10] 423578 0
A 100-point visual analog scale (VAS) related to the weight of the shoe with a negative anchor point on the left end of the scale (0), an "ideal" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [10] 423578 0
A 12-item visual analog scale related to 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 [11] 423579 0
A 100-point visual analog scale (VAS) related to whether the participant experienced pleasure/displeasure in the shoe with a negative anchor point on the left end of the scale (0), a "neutral" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [11] 423579 0
A 12-item visual analog scale related to 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 [12] 423581 0
A 100-point visual analog scale (VAS) related to whether the participant found the shoe easier/harder to run in with a negative anchor point on the left end of the scale (0), a "neutral" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [12] 423581 0
A 12-item visual analog scale related to 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 [13] 423582 0
A 100-point visual analog scale (VAS) related to performance with a negative anchor point on the left end of the scale (0), a "neutral" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [13] 423582 0
A 12-item visual analog scale related to 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 [14] 423583 0
A 100-point visual analog scale (VAS) related to injury risk with a negative anchor point on the left end of the scale (0), a "neutral" anchor point at 50 mm, and a positive anchor point at the positive end of the scale (100) completed on an Apple iPad using the Qualtrics software.
Timepoint [14] 423583 0
A 12-item visual analog scale related to 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 [15] 423584 0
A running footwear comfort assessment tool (RUN-CAT) will be derived from 4 of the 12 VAS items; heel cushioning, forefoot cushioning, forefoot flexibility, and shoe stability.
Timepoint [15] 423584 0
The 4 RUN-CAT items will be completed at the end of each running economy trial once the shoe conditions have been removed from the participants.
Secondary outcome [16] 423585 0
Shoe preference data for comfort. Participants will be asked to identify which of the two shoe conditions they thought was more comfortable.
Timepoint [16] 423585 0
At the end of the four running economy trials.
Secondary outcome [17] 423586 0
Shoe preference data for performance. Participants will be asked to identify which of the two shoe conditions they thought they would perform the best in.
Timepoint [17] 423586 0
At the end of the four running economy trials.
Secondary outcome [18] 423587 0
Shoe preference data for injury risk. Participants will be asked to identify which of the two shoe conditions they thought their injury risk was the lowest.
Timepoint [18] 423587 0
At the end of the four running economy trials.
Secondary outcome [19] 423588 0
Contact time (ms) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [19] 423588 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [20] 423589 0
Flight time (ms) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [20] 423589 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [21] 423590 0
Cadence (steps/min) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [21] 423590 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [22] 423591 0
Step length (m) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [22] 423591 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [23] 423592 0
Vertical displacement (cm) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [23] 423592 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [24] 423593 0
Hip joint angles (deg) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [24] 423593 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [25] 423594 0
Knee joint angles (deg) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [25] 423594 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [26] 423595 0
Ankle joint angles (deg) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [26] 423595 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [27] 423596 0
Metatarsophalangeal (MTP) joint angles (deg) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [27] 423596 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [28] 423597 0
Hip joint velocities (deg/s) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [28] 423597 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [29] 423598 0
Knee joint velocities (deg/s) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [29] 423598 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [30] 423599 0
Ankle joint velocities (deg/s) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [30] 423599 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [31] 423601 0
MTP joint velocities (deg/s) will be calculated using an average from a 30-second capture using 3D motion analysis recording (Qualisys 3D motion capture system, Sweden). Retro-reflective markers will be placed on the posterior and anterior pelvis, lateral thigh and shins, lateral epicondyle of the knees and lateral malleoli, and nine markers on the foot and shoe before testing.
Timepoint [31] 423601 0
3D image capture will be collected for thirty seconds in the 5th minute of each running economy trial. The above measures will be calculated over a 30-second period from this capture, averaged and used for analysis.
Secondary outcome [32] 423602 0
Kinetic parameters will be calculated using an average from a 30-second capture using an inertial measurement unit recording device (Vicon Trident Blue). Sensors will be placed above the medial malleolus bilaterally. The parameter of interest is the resultant tibial acceleration (g).
Timepoint [32] 423602 0
Sensor data will be collected for thirty seconds in the 5th minute of each running economy trial, and the average from this time period used for the analysis.

Eligibility
Key inclusion criteria
Twenty-six female recreational runners who are comfortable running on a treadmill will be recruited for this study. More specifically, participants will be included if they have been running for more than six months regularly, run 1 to 5 times a week, and run a 5 km distance above 20 minutes. Participants will also be required to be able to run comfortably for 45 minutes in total. Runners will also have to fit the available shoe sizes (7.5 to 9.5 US)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Runners will be excluded if they are currently injured or have been injured in the last month according to the following consensus definition: Running related (training or competition) musculoskeletal pain in the lower limbs that causes a restriction on or stoppage of running (distance, speed, duration, or training) for at least 7 days or 3 consecutive scheduled training sessions, or that requires the runner to consult a physician or other health professional.

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)
Participants will test the shoe conditions in a randomised mirror sequence so each condition is run in twice. The order of conditions will be block randomised prior to study commencement by a third party to ensure an equal number of participants starting in each condition, and allocated sequentially to participants upon study enrolment by a single researcher. Participants will either be allocated Shoe A + Shoe B + Shoe B + Shoe A; or Shoe B + Shoe A + Shoe A + Shoe B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Participants will also be briefly interviewed at the end of the trials to determine if they were aware of the deception or not (i.e., to see if they suspected the two shoes were the same).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on prior work detecting an effect size difference of 0.61 in running economy between the most and least comfortable shoes, a sample of 26 runners would be needed for this study to achieve a 5% significance level and 80% power. This sample size would be sufficient to detect differences in comfort ratings between footwear conditions assuming an effect size of 0.706 at a 5% significance level and 92% power, and will allow for the possibility of 10% of missing data.

Parametric or non-parametric approaches will be implemented based on data distribution. Discrete data will be statistically compared between shoes using paired t-tests or Wilcoxon tests, and effect size differences in means will be computed. Statistical parametric mapping will be used for time-series data analysis. We will set a threshold alpha level equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 25600 0
New Zealand
State/province [1] 25600 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 314102 0
University
Name [1] 314102 0
University of Waikato
Country [1] 314102 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
University of Waikato, Adams Centre for High Performance
52 Miro Street, Mount Maunganui 3116
Bay of Plenty
Country
New Zealand
Secondary sponsor category [1] 316019 0
None
Name [1] 316019 0
Address [1] 316019 0
Country [1] 316019 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313240 0
University of Waikato - Human Research Ethics Committee
Ethics committee address [1] 313240 0
Ethics committee country [1] 313240 0
New Zealand
Date submitted for ethics approval [1] 313240 0
01/03/2023
Approval date [1] 313240 0
13/04/2023
Ethics approval number [1] 313240 0
HREC(HECS)2023#13

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

Contacts
Principal investigator
Name 127450 0
Dr Kim Hébert-Losier
Address 127450 0
The University of Waikato, Adams Centre for High Performance
52 Miro Street,
Mount Maunganui 3116
Bay of Plenty
Country 127450 0
New Zealand
Phone 127450 0
+6478379476
Fax 127450 0
Email 127450 0
[email protected]
Contact person for public queries
Name 127451 0
Kim Hébert-Losier
Address 127451 0
The University of Waikato, Adams Centre for High Performance
52 Miro Street,
Mount Maunganui 3116
Bay of Plenty
Country 127451 0
New Zealand
Phone 127451 0
+6478379476
Fax 127451 0
Email 127451 0
[email protected]
Contact person for scientific queries
Name 127452 0
Kim Hébert-Losier
Address 127452 0
The University of Waikato, Adams Centre for High Performance
52 Miro Street,
Mount Maunganui 3116
Bay of Plenty
Country 127452 0
New Zealand
Phone 127452 0
+6478379476
Fax 127452 0
Email 127452 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). Data will include participant characteristics, oxygen consumption, energy cost, the energetic cost of transport, subjective measures, RUN-CAT, spatiotemporal, kinematic, and kinetics.
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.