- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429310
Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC (AdjIC)
Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
Study Overview
Status
Intervention / Treatment
Detailed Description
The circulation of blood around the body is dependent on effective pumping of the heart. Patients with claudication experience pain or discomfort in their legs usually during activity such as walking, which goes away at rest. Claudication is a symptom of peripheral arterial disease (PAD). If left untreated, patients can develop arterial insufficiency which can lead to various complications such as swelling, painful legs, reduced healing of injuries and the loss of limbs in extreme conditions.
PAD can be defined as a narrowing of the arteries reducing blood flow. It is most commonly due to atherosclerosis, and has associations with heart disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population, increasing with age to about 20% in the over-seventies. It is associated with effects on mobility, skin condition and quality of life. Symptoms include pain in the legs on walking (intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss. Management of PAD is based on encouraging exercise, and modification of risk factors such as smoking, high blood pressure, high cholesterol and diabetes.
In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be treated by procedures such as balloon angioplasty, stenting or surgical bypass, but these procedures have risks. There also remains a percentage of patients who are not suitable for revascularisation, and have few options besides amputation available to them.
Current NICE guidelines (NICE Clinical Guideline 147: Lower Limb Peripheral Arterial Disease:Diagnosis and Management guidance.nice.org.uk/cg147) advise a supervised exercise programme should be offered to all patients with IC as well as best medical therapy. Regular exercise has shown to significantly improve symptoms of IC in patients, but the effects of this benefit quickly revert upon inactivity.
Some trials have shown that increasing the blood flow in the legs over time using medical devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal medical and surgical therapy, can increase claudication distance, absolute walking distance, decrease rest pain, and reduce amputation rates. In our unit it has become apparent that there are an increasing number of medical devices available for circulatory support, either for use as an inpatient, out-patient, or a member of the general public. The supporting evidence for these is variable in scientific and clinical content or relevance, and requires clinical trials to evaluate further.
The device being used in this study activates the pumping action of the leg muscles by providing neuromuscular electrical stimulation (NMES) to cause foot muscle contraction and relaxation. This squeezes blood back towards the heart, improving circulation.
The investigators wish to evaluate whether NMES using this device has the same beneficial effects in patients with claudication when used in conjunction with supervised exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hammersmith
-
London, Hammersmith, United Kingdom, W6 8FS
- Imperial College London - Charing Cross Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with intermittent claudication who have the following are eligible for the study:
- All ethnic groups, male or female above the age of 18 years.
- Diagnosis of intermittent claudication
- Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours, if appropriate, before using the study device.
- Blood pressure currently under moderate control (< 160/100mmHg)
- No current foot ulceration
Exclusion Criteria:
Patients meeting any of the following criteria are to be excluded:
- Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.
- Has renal failure
- Has diabetes
- Has an ankle-brachial pressure index (ABPI) >0.9
- Has any metal implants
- Pregnant
- Has a cardiac pacemaker or defibrillator device
- Has recent lower limb injury or lower back pain
- Has current foot ulceration or other skin ulcers
- Has foot deformities
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Supervised Exercise Only
This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
|
|
Experimental: NMES + Supervised Exercise
This cohort of patients with Intermittent Claudication will receive the standard care of supervised exercise plus the use of a Revitive IX neuromuscular electrical stimulation device (Intervention) as per the protocol.
The adjunctive benefit of the latter intervention compared to standard treatment alone will then be assessed.
|
This is a neuromuscular electrical stimulation device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial Walking Distance Measured by Treadmill
Time Frame: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline) - 6 week - baseline values.
|
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.
|
Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline) - 6 week - baseline values.
|
Absolute Walking Distance Measured by Treadmill
Time Frame: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)
|
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.
|
Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
Time Frame: Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.
|
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.
|
Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.
|
Laser Doppler Flow Measured by Optical Laser
Time Frame: Change in baseline flowmetry at 6 weeks
|
Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
|
Change in baseline flowmetry at 6 weeks
|
Symptomatic Scores by Questionnaire
Time Frame: 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.
|
Change in baseline questionnaire scores at 6 weeks
|
Quality of Life Scores Measured by Questionnaire
Time Frame: 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.
|
Change in baseline quality of life at 6 weeks
|
Urine Metabolic Profile
Time Frame: 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.
|
Change of profile at baseline and at 6 weeks
|
Serum Metabolic Profile
Time Frame: 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.
|
Change of profile at baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alun H Davies, MA FRCS DM, Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14HH2042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intermittent Claudication
-
Mid and South Essex NHS Foundation TrustRecruitingPeripheral Arterial Disease | Claudication, IntermittentUnited Kingdom
-
Louis MessinaBioMarin PharmaceuticalRecruitingPeripheral Vascular Diseases | Peripheral Artery Disease | Claudication, IntermittentUnited States
-
University Hospital, AngersCompletedPeripheral Artery Disease | Claudication, IntermittentFrance
-
Palo Alto Veterans Institute for ResearchSociety for Vascular SurgeryWithdrawnPeripheral Artery Disease | Claudication, Intermittent
-
Biotronik AGCompletedSevere Intermittent Claudication | Patients With Symptomatic Critical Limb IschemiaGermany
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity Hospital, Angers; Imperial College London; Sheffield Hallam UniversityCompletedIntermittent ClaudicationUnited Kingdom
-
University Hospital, EssenStraub Medical AGUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
-
University Hospital, EssenUnknownPeripheral Arterial Disease | Claudication, IntermittentGermany
-
Paradigm SpineCompletedIntermittent Neurogenic Claudication (INC) as a Result of Spinal StenosisNetherlands
-
Imperial College LondonTerminatedStandardised Claudication Treadmill TestUnited Kingdom
Clinical Trials on Revitive IX
-
Imperial College LondonTerminatedPeripheral Arterial Disease | Critical Limb IschaemiaUnited Kingdom
-
Imperial College LondonActegy Ltd.CompletedVaricose Veins | Venous Insufficiency | OedemaUnited Kingdom
-
Imperial College LondonActegy Ltd.CompletedVaricose Veins | Venous Insufficiency | Venous Stasis
-
Imperial College LondonCompleted
-
Imperial College Healthcare NHS TrustWithdrawnPeripheral Arterial Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Femoral Popliteal OcclusionUnited Kingdom
-
Ixchelsis LimitedCompletedPremature EjaculationUnited States
-
Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
-
Bioverativ Therapeutics Inc.Swedish Orphan BiovitrumCompletedSevere Hemophilia BSweden, United States, France, Italy, Russian Federation, United Kingdom, Germany, China, Poland, Japan, Australia, Brazil, Canada, India, South Africa, Hong Kong, Belgium
-
Baxalta now part of ShireBaxalta Innovations GmbH, now part of ShireCompleted
-
Ixchelsis LimitedHealthCore-NERI; Novotech (Australia) Pty Limited; ICON plc; PHT CorporationCompletedPremature EjaculationUnited States, Australia