Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr M H Simms

ORCID ID

Contact details

Vascular Surgery
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
+44 (0)121 627 1627

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265126505

Study information

Scientific title

Acronym

Study hypothesis

1. Does a shuttle walk test of claudicants' functional capabilities detect improvements in calf muscle function resulting from treatment with chronic electrical stimulation for 4 weeks?
2. Will an intermittent programme (3 or 4 weeks intervention, 1 or 2 weeks non intervention) of chronic electrical stimulation of calf muscles in claudicants provide sustained improvements in calf muscle function and walking ability?
3. Does chronic electrical stimulation of calf muscles in claudicants and age-matched control subjects have vascular effects and improve nutritive circulation?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Intermittent claudication

Intervention

In summary, eligible participants who have given informed consent will be familiarised with the testing procedures and equipment at the first visit. They will return after 1 week and be re-tested to give baseline values and then allocated to receive either an active muscle stimulator or a cutaneous nerve stimulator (TENS) as control. Two protocols for chronic stimulation are proposed to take account of patient availability for the duration of the study. One will use stimulators for 3 weeks at a time followed by a 1 week rest period. The other will use stimulators for 4 weeks at a time, followed by a 2 week rest period.

After stimulation at home for 3 periods of 20 minutes each day for either 3 or 4 weeks, participants will be reassessed. A rest period of 1 or 2 weeks will then be allowed followed by testing to establish whether any treatment-induced changes have reverted. Treatment - muscle stimulation or TENS - will then be resumed for a period of 3 or 4 weeks, followed by reassessment. After a further 1 or 2 week rest period, participants will undergo a final assessment which completes the study.

Participants in the study will therefore be required to attend on the following occasions:

1. Week 1 - Estimated duration 2 hr 30 min
As part of normal clinical evaluation at the Vascular Clinic prior to recruitment, a standard history will have been taken and general medical examination performed. Participants will be given a full explanation of the study including time to read the Patient Information Leaflet and the opportunity to ask any questions. Those who fulfil the selection criteria and give informed consent will be eligible to participate in the study. At the first visit for the study a treadmill test and shuttle walk test will be performed with full arterial assessment and a demonstration of the chair testing method will be given. After a 1 hour break with refreshments, the participants will undergo a formal assessment in the chair. During the break, the participant will be asked to complete the SF 36 questionnaire. Each participant will be issued with a physical activity logger device (a pedometer) and asked to wear it during the day throughout the following week. They will be invited to return after a period of 1 week for randomisation and commencement of treatment.

2. Week 2 - Estimated duration 3 hr
Participants will undergo a treadmill test and shuttle walk test with full arterial assessment. There will then be a period of rest for 1 hour with refreshments. Participants will then undergo a chair test. They will also undergo assessment of lower leg vascular function using venous occlusion plethysmography. Participants will then be randomised to a treatment group, either active (stimulation) or placebo (TENS). Following instruction in the use of the device they will be asked to commence treatment the next morning for a period of 3 or 4 weeks. Participants will be asked to hand in the activity logger used during the previous week and complete a Seven Day Physical Activity Recall questionnaire (PARQ). They will then be issued with another physical activity logger device and be asked to wear it during the day throughout the last week of stimulation.

3. Week 5 or 6 - Estimated duration 3 hr
Participants will undergo the full testing procedure (treadmill test, shuttle walk test, arterial assessment, chair test, vascular function test) as at week 2 and be asked to complete the SF 36 and PAR questionnaires. They will be instructed to cease treatment for a period of 1 or 2 weeks and proceed with normal daily activities.

4. Week 6 or 8 - Estimated duration 3 hr
Participants will undergo the testing procedure as at week 2 and 5/6 including the SF 36 questionnaire but excluding the shuttle walk test. They will be instructed to commence treatment as at week 2, either active muscle stimulation or TENS placebo, for a period of 3 or 4 weeks.

5. Week 9 or 12 - Estimated duration 2 hr 30 min
Participants will undergo the testing procedure as at week 6/8 (treadmill test, arterial assessment, chair test, vascular function test) including the SF 36 questionnaire.

6. Week 10 or 14 - Estimated duration 2 hr
Participants will undergo a testing session consisting of a chair test and vascular function test and SF36 questionnaire. They will then be discharged from the study.

The protocols used for assessment of walking ability (treadmill and shuttle walk test) and assessment of arterial status (ABPI5) are used routinely in patient assessment. Stimulators are routinely used in the treatment of patients with a variety of conditions.
The protocols for chair testing and assessment of vascular function (blood flow, capillary filtration capacity) are specifically for research purposes.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

27/06/2003

Overall trial end date

27/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with intermittent claudication who have been assessed in the Vascular Clinic at Selly Oak Hospital and who are not candidates for surgical intervention will be invited to participate in the study. Number of patients - up to 40. Inclusion criteria:
1. Sex - male and female
2. Age superior or equal to 40 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Up to 40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

27/06/2003

Recruitment end date

27/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Vascular Surgery
Birmingham
B29 6JD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14718904

Publication citations

  1. Results

    Anderson SI, Whatling P, Hudlicka O, Gosling P, Simms M, Brown MD, Chronic transcutaneous electrical stimulation of calf muscles improves functional capacity without inducing systemic inflammation in claudicants., Eur J Vasc Endovasc Surg, 2004, 27, 2, 201-209, doi: 10.1016/j.ejvs.2003.10.003.

Additional files

Editorial Notes