Intermittent ClaudicationAdjICNCT02429310
Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
A study testing Revitive IX in people with Intermittent Claudication and Peripheral Vascular Disease, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Disease, Lower Limb Arterial Disease
- What is being tested?
- Revitive IX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London - Charing Cross Hospital
London, Hammersmith, W6 8FS
About this study
Official title: Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
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.
Read the 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.
- Being tested
- Revitive IX
- 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
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revitive IXDevice
This is a neuromuscular electrical stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Only | No intervention | This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only. |
| NMES + Supervised Exercise | Experimental | 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. Receives: Device: Revitive IX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change in baseline treadmill walking distance at 6 weeks (positive numbers indicate increase from baseline, negative numbers indicate decrease from baseline)
Secondary outcomes (6)
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.
Measured: Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.
Laser Doppler Flow Measured by Optical Laser
Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.
Measured: Change in baseline flowmetry at 6 weeks
Symptomatic Scores by Questionnaire
Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.
Measured: Change in baseline questionnaire scores at 6 weeks
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.
Measured: Change in baseline quality of life at 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.
Measured: Change of profile at baseline and at 6 weeks
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.
Measured: Change of profile at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, MA FRCS DM, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429310
- Sponsor's protocol ID
- 14HH2042
- Acronym
- AdjIC
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2015
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31912491
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Benefit of Neuromuscular Electrical Stimulation to Supervised Exercise in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT02429310
- Acronym / sponsor ID
- AdjIC / 14HH2042
- Keywords
- Intermittent Claudication, IC, Peripheral Arterial Disease, Peripheral Vascular Disease, Peripheral Arterial Occlusive Disease, Lower Limb Arterial Disease, Supervised Exercise Therapy, Supervised Exercise Programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Only | No intervention | –This is the cohort of patients with Intermittent Claudication that will receive standard care of a supervised exercise programme only. |
| NMES + Supervised Exercise | Experimental | Device: Revitive IXThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with intermittent claudication who have the following are eligible for the study:
Key exclusion criteria (12 listed)
- Patients meeting any of the following criteria are to be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revitive IXThis is a neuromuscular electrical stimulation device | Device | NMES + Supervised Exercise |
Primary outcome
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.
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.
6 secondary outcomes
Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography
Time frame: 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
Symptomatic Scores by Questionnaire
Time frame: 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
Urine Metabolic Profile
Time frame: Change of profile at baseline and at 6 weeks
Serum Metabolic Profile
Time frame: Change of profile at baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31912491Babber 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.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies, MA FRCS DM principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revitive IX in people with Intermittent Claudication and Peripheral Vascular Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.