Clinical trial NCT02429310: Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
Official title: Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Peripheral Vascular Disease
Lower Limb Arterial Disease
Keywords: 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
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Initial Walking Distance Measured by Treadmill
timeFrame: 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.
measure: Absolute Walking Distance Measured by Treadmill
timeFrame: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)
Secondary outcomes:
measure: Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
timeFrame: Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.
measure: Laser Doppler Flow Measured by Optical Laser
timeFrame: Change in baseline flowmetry at 6 weeks
measure: Symptomatic Scores by Questionnaire
timeFrame: Change in baseline questionnaire scores at 6 weeks
measure: Quality of Life Scores Measured by Questionnaire
timeFrame: Change in baseline quality of life at 6 weeks
measure: Urine Metabolic Profile
timeFrame: Change of profile at baseline and at 6 weeks
measure: Serum Metabolic Profile
timeFrame: Change of profile at baseline and 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London - Charing Cross Hospital
state: Hammersmith
Study officials:
affiliation: Imperial College London
name: Alun H Davies, MA FRCS DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Babber A, Ravikumar R, Onida S, Lane TRA, Davies AH. Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial. Br J Surg. 2020 Mar;107(4):355-363. doi: 10.1002/bjs.11398. Epub 2020 Jan 7.