A comparison of upper-limb and lower-limb exercise training in patients with intermittent claudication (IC)
- Conditions
- Peripheral arterial disease.Circulatory SystemOther peripheral vascular diseases
- Registration Number
- ISRCTN76180797
- Lead Sponsor
- Sheffield Hallam University (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 104
Patients with stable intermittent claudication were recruited from the Sheffield Vascular Institute at the Northern General Hospital, Sheffield, UK. The clinical diagnosis of PAD was established using the patient?s history and a physical examination, and was confirmed by the Doppler assessment of ankle-brachial pressure index (ABPI), a non-invasive reliable measure of lower-extremity hemodynamics, in accordance with current UK medical practice.
Patients experiencing symptoms of IC for less than 12 months, or reporting a significant change in walking ability within this time period were considered to have unstable disease and were, as a consequence, excluded. Patients were also excluded if they exhibited features of critical ischemia, had undergone a re-vascularization procedure within the previous 12 months, or if initial assessment established that they suffered from severe arthritis (i.e. if they were unable to walk unaided or perform either upper- or lower limb cranking exercise due to joint pain), severe lumbar spine disease or unstable cardiorespiratory conditions (i.e. unstable blood pressure, recent electrocardiographic changes or acute myocardial infarction, unstable angina, third-degree heart block, acute congestive heart failure and severe respiratory conditions).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Walking performance (claudication distance and maximum walking distance).
- Secondary Outcome Measures
Name Time Method 1. Upper- and lower-limb aerobic exercise capacity<br>2. Disease-specific and generic quality of life measures<br>3. Blood markers of cardiovascular disease risk