Evaluating Non-Invasive Haptics During Extreme Exercise

NCT07285252 | Enrolling By Invitation

• 1 other identifier: ENDURE-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

VO2max; Lactate Threshold; Lactate

Keywords

VO2 max; lactate threshold; lactate

Outcome Measures

Primary Outcomes (1)

• Change in VO2 Max

  Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average)

  2-weeks and 4-weeks after baseline assessment

Secondary Outcomes (1)

• Change in Lactate-threshold running speed

  2-weeks and 4-weeks after baseline assessment

Study Arms (2)

TREATMENT

ACTIVE COMPARATOR

Victory Patch

Device: Victory Patch with Haptic Vibrotactile Trigger Technology

CONTROL

PLACEBO COMPARATOR

Sham Comparator

Device: Sham patch

Interventions

Victory Patch with Haptic Vibrotactile Trigger Technology DEVICE

Active Patch with Haptic Vibrotactile Trigger Technology

TREATMENT

Sham patch DEVICE

Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology

CONTROL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• Clarity Science LLC: collaborator
• The Altitude Centre: collaborator
• Vichag Healthcare Research: collaborator

Study Sites (1)

The Altitude Centre

London, UK, E1 6AH, United Kingdom

Location

Study Officials

• Mark Sakr, DO

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: January 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon Initiation of the Study
• Access Criteria: Current Study Investigators and associated Research Staff

Locations

GB (1)