Intermittent claudication Musculoskeletal Diseases Other peripheral vascular diseases
Conditions
Interventions
Volunteer claudicants will be recruited onto the study via attendance at the Lifestyle Management Clinic in the Vascular Department at Wirral University Teaching Hospitals NHS Trust, Wirral, England,
Sponsors
University of Salford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, over 18 years of age. There are no upper age limits 2. Those who have been diagnosed with stabilised intermittent claudication in one or both calf muscles 3. Ankle brachial pressure index of 0.8 or less 4. Those who have a maximum walking distance of between 10-300 m before having to stop walking due to their calf pain which is not being improved by other conservative interventions
Exclusion criteria
Exclusion criteria: Subjects with a history of lower limb joint replacement, cerebrovascular accident (CVA), or any orthopaedic or neurological impairment which adversely affects their gait or negates the fitting of stock therapeutic shoes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following hospital-based walking trials will be held immediately before and after the two-week home trials: 1. Pain-free walking distance (PFWD) to the sudden onset of calf claudication pain 2. Overall intensity of calf claudication pain whilst claudicating 3. Maximum walking distance (MWD) before having to stop due to the intensity of the calf pain 4. Walking speed, step length and cadence | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QOL) indicators using the intermittent claudication questionnaire (ICQ) before and after the two-week trial. It is anticipated that a future larger trial will be needed to provide statistically significant differences to QOL indicators, but this trial will give an indication and will inform the total number of recruits required in a subsequent trial study. | — |
Countries
United Kingdom
Outcome results
None listed