Evaluating Non-Invasive Haptics During Extreme Exercise (ENDURE)

December 3, 2025 updated by: SuperPatch Limited LLC

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • London, UK, United Kingdom, E1 6AH
        • The Altitude Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TREATMENT
Victory Patch
Device: Victory Patch with Haptic Vibrotactile Trigger Technology
Active Patch with Haptic Vibrotactile Trigger Technology
Placebo Comparator: CONTROL
Sham Comparator
Device: Sham patch
Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2-weeks and 4-weeks after baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lactate-threshold running speed
Time Frame: 2-weeks and 4-weeks after baseline assessment
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).
2-weeks and 4-weeks after baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperPatch Limited LLC

Collaborators

Clarity Science LLC
The Altitude Centre
Vichag Healthcare Research

Investigators

  • Principal Investigator: Mark Sakr, DO, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENDURE-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Upon Initiation of the Study

IPD Sharing Access Criteria

Current Study Investigators and associated Research Staff

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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