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Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC (AdjIC)

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ClinicalTrials.gov Identifier: NCT02429310
Recruitment Status : Unknown
Verified February 2016 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : April 29, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
This study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Peripheral Vascular Disease Lower Limb Arterial Disease Device: Revitive IX Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
Study Start Date : December 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.
Device: Revitive IX
This is a neuromuscular electrical stimulation device




Primary Outcome Measures :
  1. Initial walking distance measured by treadmill [ Time Frame: Change in baseline treadmill walking distance at 6 weeks ]
    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.

  2. Absolute walking distance measured by treadmill [ Time Frame: 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.


Secondary Outcome Measures :
  1. Femoral Haemodynamics measured by Femoral artery Duplex Ultrasonography [ Time Frame: 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429310


Contacts
Contact: Adarsh Babber, MBChB MSc MRCS 07946646855 a.babber@imperial.ac.uk

Locations
United Kingdom
Imperial College London - Charing Cross Hospital Recruiting
London, Hammersmith, United Kingdom, W6 8FS
Contact: Adarsh Babber, BSc MBChB MSc MRCS    07946 646 855    a.babber@imperial.ac.uk   
Principal Investigator: Alun H Davies, BA BCh BM MA FRCS         
Sub-Investigator: Adarsh Babber, BSc MBChB MSc MRCS         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alun H Davies, BA BM ChB MA FRCS DM Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02429310     History of Changes
Other Study ID Numbers: 14HH2042
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Imperial College London:
Intermittent Claudication
IC
Peripheral Arterial Disease
Peripheral Vascular Disease
Peripheral Arterial Occlusive Disease
Lower Limb Arterial Disease
Supervised Exercise Therapy
Supervised Exercise Programme
Exercise Therapy

Additional relevant MeSH terms:
Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms
Atherosclerosis