VO2maxENDURENCT07285252
Evaluating Non-Invasive Haptics During Extreme Exercise
A study testing Victory Patch with Haptic Vibrotactile Trigger Technology in people with VO2max and Lactate Threshold, run by SuperPatch Limited LLC at 1 site in United Kingdom.
Trial summary
This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- VO2max, Lactate Threshold, Lactate
- What is being tested?
- Victory Patch with Haptic Vibrotactile Trigger Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and over, that participate in recreational to competitive distance running (>2 structured runs per week), that were able to complete maximal treadmill exercise safely and were able to attend three laboratory visits were invited to participate.
Who cannot join
- Adults with a contraindications to high-intensity treadmill exercise, cardiovascular, metabolic, or musculoskeletal conditions limiting participation, reported use of performance-enhancing drugs, pregnancy, known allergy to adhesives, or current use of neuromodulatory or haptic devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ENDURE- Evaluating Non-Invasive Haptics During Extreme Exercise
This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period.
- Conditions
- VO2max, Lactate Threshold, Lactate
- Being tested
- Victory Patch with Haptic Vibrotactile Trigger Technology, Sham patch
- Keywords
- VO2 max, lactate threshold, lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Victory Patch with Haptic Vibrotactile Trigger TechnologyDevice
Active Patch with Haptic Vibrotactile Trigger Technology
Sham patchDevice
Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Active comparator | Victory Patch Receives: Device: Victory Patch with Haptic Vibrotactile Trigger Technology |
| CONTROL | Placebo comparator | Sham Comparator Receives: Device: Sham patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 Max
Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average)
Measured: 2-weeks and 4-weeks after baseline assessment
Secondary outcomes (1)
Change in Lactate-threshold running speed
Measurement of Lactate-threshold running speed using capillary sampling (LT, km/h-¹), determined using a DmodMax algorithm on lactate-speed curves [15], (2) serum lactate level at threshold (mmol·L-¹).
Measured: 2-weeks and 4-weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VO2maxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, non-randomised, double-blinded, parallel-group internal pilot study evaluating the acceptability, safety, recruitment processes, data-collection procedures, and preliminary performance signals of the SuperPatch VICTORY vibrotactile patch in recreational-competitive runners. The Study was designed to inform a future fully-powered interventional study. The study follows the CONSORT Extension for Pilot and Feasibility Trials. The study involves comparison of data from two parallel groups: (1) an active intervention group using SuperPatch VICTORY Patch (intervention) versus (2) a placebo group using a visually identical patch lacking the vibrotactile neurosensory pattern. Participants will be followed for four weeks with lab-based assessments at baseline (Week 0), Week 2, and Week 4.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuperPatch Limited LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC, The Altitude Centre, Vichag Healthcare Research
- Responsible party
- Sponsor
- Investigators
- Mark Sakr, DO, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285252
- Sponsor's protocol ID
- ENDURE-001
- Acronym
- ENDURE
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDURE- Evaluating Non-Invasive Haptics During Extreme Exercise
- ClinicalTrials.gov ID
- NCT07285252
- Acronym / sponsor ID
- ENDURE / ENDURE-001
- Conditions
- VO2max, Lactate Threshold, Lactate
- Keywords
- VO2 max, lactate threshold, lactate
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- SuperPatch Limited LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clarity Science LLC, The Altitude Centre, Vichag Healthcare Research
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, non-randomised, double-blinded, parallel-group internal pilot study evaluating the acceptability, safety, recruitment processes, data-collection procedures, and preliminary performance signals of the SuperPatch VICTORY vibrotactile patch in recreational-competitive runners. The Study was designed to inform a future fully-powered interventional study. The study follows the CONSORT Extension for Pilot and Feasibility Trials. The study involves comparison of data from two parallel groups: (1) an active intervention group using SuperPatch VICTORY Patch (intervention) versus (2) a placebo group using a visually identical patch lacking the vibrotactile neurosensory pattern. Participants will be followed for four weeks with lab-based assessments at baseline (Week 0), Week 2, and Week 4.
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Active comparator | Device: Victory Patch with Haptic Vibrotactile Trigger TechnologyVictory Patch |
| CONTROL | Placebo comparator | Device: Sham patchSham Comparator |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years and over, that participate in recreational to competitive distance running (>2 structured runs per week), that were able to complete maximal treadmill exercise safely and were able to attend three laboratory visits were invited to participate.
Key exclusion criteria (1 listed)
- Adults with a contraindications to high-intensity treadmill exercise, cardiovascular, metabolic, or musculoskeletal conditions limiting participation, reported use of performance-enhancing drugs, pregnancy, known allergy to adhesives, or current use of neuromodulatory or haptic devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Victory Patch with Haptic Vibrotactile Trigger TechnologyActive Patch with Haptic Vibrotactile Trigger Technology | Device | TREATMENT |
| Sham patchSham/Placebo Patch without Haptic Vibrotactile Trigger Technology | Device | CONTROL |
Primary outcome
Change in VO2 Max
Time frame: 2-weeks and 4-weeks after baseline assessment
Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average)
1 secondary outcome
Change in Lactate-threshold running speed
Time frame: 2-weeks and 4-weeks after baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for VO2max
Enrolling by invitationObservational study
Test-Retest Reliability And Validation For End-Tidal Carbon Dioxide Measurement (PetCO2) During Rest And Low-Loaded Steady State Work Using A Portable Capnograph.
Cardiopulmonary Exercise Test, End-Tidal Carbon Dioxide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Sakr, DO principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Victory Patch with Haptic Vibrotactile Trigger Technology in people with VO2max and Lactate Threshold, run by SuperPatch Limited LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 Max (time frame: 2-weeks and 4-weeks after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.