TRI-HEX Study (v1.0)
Research type
Research Study
Full title
Evaluation of Lower Limb Haemodynamics using Three (TRI) NMES Foot Pad Programs: A Crossover (X) Randomised Controlled Study (HE) in Healthy Adults.
IRAS ID
342162
Contact name
Joey Porter
Contact email
Sponsor organisation
Actegy Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
The Revitive Medic Coach is an approved medical device that uses electrical muscle stimulation through foot pads to help improve blood flow in the legs. This muscle activity helps increase blood flow in the legs during use. The device is commonly used by adults to help manage symptoms such as aching, tiredness, and cramping in the legs.
Recent research has aided development of 2 new stimulation programs that have shown promise in a pilot study to further improve how blood moves through the lower limbs. This study will evaluate these new programs alongside the current Revitive “Medic” program over a single 30-minute session.
This study will involve 24 healthy adults. Each participant will attend 4 visits over about 4 weeks, including 1 familiarisation visit and 3 test visits. During each test visit, participants will use the Revitive Medic Coach device for 30 minutes with 1 of the 3 stimulation programs, receiving each program once over the course of the study. Blood flow will be measured using a painless non-invasive ultrasound scan of the upper thigh.
The study is being run by Actegy Ltd, the manufacturer of the Revitive Medic Coach device. All sessions will take place at Actegy’s research facility, and participants will be recruited from the local area.
The results will help Actegy understand whether the new stimulation programs can improve circulation more effectively, which could lead to better management of leg discomfort in the future.
The study will be registered on public trial databases, including ISRCTN and ClinicalTrials.gov.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
26/WM/0029
Date of REC Opinion
10 Mar 2026
REC opinion
Further Information Favourable Opinion