VO2max, Lactate Threshold, Lactate
Conditions
Keywords
VO2 max, lactate threshold, lactate
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.
Interventions
DEVICEVictory Patch with Haptic Vibrotactile Trigger Technology
Active Patch with Haptic Vibrotactile Trigger Technology
DEVICESham patch
Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology
Sponsors
Clarity Science LLC
The Altitude Centre
Vichag Healthcare Research
SuperPatch Limited LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2 Max | 2-weeks and 4-weeks after baseline assessment | Change in VO₂max (mL/kg-¹/min-¹, calculated as a 30-second rolling average) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lactate-threshold running speed | 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). |
Countries
United Kingdom
Outcome results
None listed