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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14718904
Publication citations
-
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.