Evaluating Non-Invasive Haptics During Extreme Exercise (ENDURE)

SuperPatch Limited LLC

Status: Invitation-only

Conditions: VO2max; Lactate; Lactate Threshold

Treatments: Device: Sham patch; Device: Victory Patch with Haptic Vibrotactile Trigger Technology

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07285252

ENDURE-001

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

TREATMENT

Active Comparator group

Description:

Victory Patch

Treatment:

Device: Victory Patch with Haptic Vibrotactile Trigger Technology

CONTROL

Placebo Comparator group

Description:

Sham Comparator

Treatment:

Device: Sham patch