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

Primary Purpose

Intermittent Claudication, Peripheral Vascular Disease, Lower Limb Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Revitive IX
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imperial College London - Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Supervised Exercise Only

NMES + Supervised Exercise

Arm Description

This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.

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.

Outcomes

Primary Outcome Measures

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.
Absolute Walking Distance Measured by Treadmill
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

Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
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.
Laser Doppler Flow Measured by Optical Laser
Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
Symptomatic Scores by Questionnaire
Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.
Quality of Life Scores Measured by Questionnaire
Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.
Urine Metabolic Profile
A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
Serum Metabolic Profile
A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.

Full Information

First Posted
April 15, 2015
Last Updated
October 5, 2020
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02429310
Brief Title
Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
Acronym
AdjIC
Official Title
Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Only
Arm Type
No Intervention
Arm Description
This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only.
Arm Title
NMES + Supervised Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Revitive IX
Intervention Description
This is a neuromuscular electrical stimulation device
Primary Outcome Measure Information:
Title
Initial Walking Distance Measured by Treadmill
Description
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.
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.
Title
Absolute Walking Distance Measured by Treadmill
Description
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.
Time Frame
Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)
Secondary Outcome Measure Information:
Title
Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
Description
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.
Time Frame
Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.
Title
Laser Doppler Flow Measured by Optical Laser
Description
Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
Time Frame
Change in baseline flowmetry at 6 weeks
Title
Symptomatic Scores by Questionnaire
Description
Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.
Time Frame
Change in baseline questionnaire scores at 6 weeks
Title
Quality of Life Scores Measured by Questionnaire
Description
Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.
Time Frame
Change in baseline quality of life at 6 weeks
Title
Urine Metabolic Profile
Description
A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
Time Frame
Change of profile at baseline and at 6 weeks
Title
Serum Metabolic Profile
Description
A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.
Time Frame
Change of profile at baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alun H Davies, MA FRCS DM
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London - Charing Cross Hospital
City
London
State/Province
Hammersmith
ZIP/Postal Code
W6 8FS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31912491
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.
Results Reference
derived

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Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC

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