Trial Outcomes & Findings for Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication (NCT NCT02436200)

Results Overview

Initial walking distance measured by treadmill For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2020-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Patients receiving neuromuscular electrical stimulation. Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patients receiving neuromuscular electrical stimulation. Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Overall Study Significant outlier	1

Baseline Characteristics

Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants Patients receiving neuromuscular electrical stimulation. Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Age, Continuous	70 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United Kingdom	20 participants n=5 Participants
Body Mass Index - BMI	27.4 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants
Ankle Brachial Pressure Index - ABPI (Right)	0.71 Ratio STANDARD_DEVIATION 0.17 • n=5 Participants
Ankle Brachial Pressure Index - ABPI (Left)	0.69 Ratio STANDARD_DEVIATION 0.17 • n=5 Participants
Initial Claudication Distance - ICD (m)	37.7 m n=5 Participants
Maximum Claudication Distance - MCD (m)	89.3 m n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Initial walking distance measured by treadmill For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants Patients receiving neuromuscular electrical stimulation. Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Change From Baseline in Initial Walking Distance	64.3 metres Interval 48.0 to 132.0

PRIMARY outcome

Timeframe: Change in baseline treadmill walking distance at 6 weeks

For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants Patients receiving neuromuscular electrical stimulation. Neuromuscular Electrical Stimulation: Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
Absolute Walking Distance Measured by Treadmill	130 m Interval 85.9 to 281.2

SECONDARY outcome

Timeframe: Change in baseline femoral haemodynamics at 6 weeks

Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline flowmetry at 6 weeks

Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline questionnaire scores at 6 weeks

Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in baseline quality of life at 6 weeks

Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change of profile at baseline and at 6 weeks

A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change of profile at baseline and 6 weeks

A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Alun Davies, Professor of Vascular Surgery

Imperial College London

Phone: +44 (0)20 3311 7309

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place