A comparison of upper-limb and lower-limb exercise training in patients with intermittent claudication (IC)
| ISRCTN | ISRCTN76180797 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76180797 |
| Secondary identifying numbers | PG/2000042 |
- Submission date
- 24/08/2005
- Registration date
- 25/10/2005
- Last edited
- 28/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Saxton
Scientific
Scientific
Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom
| Phone | +44 (0)114 225 4414 |
|---|---|
| j.m.saxton@shu.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Upper-limb aerobic exercise training will be as effective as lower-limb aerobic exercise training for evoking symptomatic improvements in patients with symptomatic peripheral arterial disease (PAD). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Peripheral arterial disease. |
| Intervention | Upper- versus lower-limb aerobic exercise training. Supervised training sessions were held twice weekly for 6 weeks with arm cranking or leg cranking. |
| Intervention type | Other |
| Primary outcome measure | Walking performance (claudication distance and maximum walking distance). |
| Secondary outcome measures | 1. Upper- and lower-limb aerobic exercise capacity 2. Disease-specific and generic quality of life measures 3. Blood markers of cardiovascular disease risk |
| Overall study start date | 01/10/2000 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 104 |
| Key inclusion criteria | 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 patients 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. |
| Key exclusion criteria | 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). |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom
S10 2BP
United Kingdom
Sponsor information
Sheffield Hallam University (UK)
University/education
University/education
City Campus
Howard Street
Sheffield
S1 1WB
England
United Kingdom
| Phone | +44 (0)114 225 5555 |
|---|---|
| liaison@shu.ac.uk | |
| Website | http://www.shu.ac.uk |
"ROR" |
https://ror.org/019wt1929 |
Funders
Funder type
Charity
British Heart Foundation (UK) - (Grant number: PG/2000042)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No | |
| Results article | results | 01/02/2006 | Yes | No | |
| Results article | results | 01/05/2008 | Yes | No |
