| Source of record | UK Trials |
| ISRCTN | ISRCTN50394448 |
| Date ISRCTN assigned | 27/09/2006 |
| Local reference number(s) | N/A |
| Public title | The effects of upper-limb aerobic exercise training on walking performance and lower limb circulatory function in patients with peripheral arterial disease |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Peripheral arterial disease (intermittent claudication) |
| Study hypothesis | 1. Upper-limb aerobic exercise training will evoke a significant improvement in walking performance in comparison to usual patient care.
2. Upper-limb aerobic exerise training will evoke a significant improvement in lower-limb circulatory function in comparison to usual patient care. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval granted by the South Sheffield Research Ethics Committee on 23/06/06 (reference number: 05/Q2305/128). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Symptoms of intermittent claudication for at least 12 months
2. Ankle Brachial Pressure Index (ABPI) more than 0.9
3. No interventional procedure in last 12 months
4. Ability to undertake exercise
5. No exercise-limiting angina
6. No shortness of breath
7. No severe arthritis |
| Participants - exclusion criteria | 1. Experiencing symptoms of intermittent claudication for less than 12 months
2. Reporting a significant change in walking ability during previous 12 months, denoting unstable claudication
3. Exhibiting features of critical limb ischaemia
4. Re-vascularisation procedure or other surgical intervention to the lower limbs in the previous 12 months
5. Severe arthritis
6. Unstable cardiopulmonary conditions such as shortness of breath or exercise-limiting angina |
| Patient information material |
|
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 31/08/2007 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | Upper-limb aerobic exercise intervention (arm-cranking exercise training, twice per week for 12 weeks) versus usual patient care. |
| Primary outcome measure(s) | Walking performance. |
| Secondary outcome measure(s) | Changes in lower-limb circulatory function. |
| Sources of funding | Sheffield Hallam University (UK) |
| Sponsor name | Sheffield Hallam University (UK) |
| Sponsor details | Centre for Sport and Exercise Science
Collegiate Crescent Campus
Sheffield
United Kingdom
S10 2BP |
| Contact name | Dr John Saxton |
| Contact details | Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
United Kingdom
S10 2BP |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN50394448 |
| Date last extracted from ISRCTN register | 17/04/2008 |
