Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC

NCT02429310 | Completed Results DMC

• 1 other identifier: 14HH2042
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Change in baseline femoral haemodynamics at 6 weeks - 6 weeks - baseline.

• Laser Doppler Flow Measured by Optical Laser

  Change in baseline flowmetry at 6 weeks

• Symptomatic Scores by Questionnaire

  Change in baseline questionnaire scores at 6 weeks

• Quality of Life Scores Measured by Questionnaire

  Change in baseline quality of life at 6 weeks

• Urine Metabolic Profile

  Change of profile at baseline and at 6 weeks

Study Arms (2)

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.

Device: Revitive IX

Interventions

Revitive IX DEVICE

This is a neuromuscular electrical stimulation device

NMES + Supervised Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London - Charing Cross Hospital

London, Hammersmith, W6 8FS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31912491 DERIVED

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Professor Alun Davies
• Organization: Imperial College London

a.h.davies@imperial.ac.uk

02033117320

Study Officials

• Alun H Davies, MA FRCS DM

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 29, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 8, 2020
• Results First Posted: September 9, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)