Contact information
Type
Scientific
Primary contact
Dr John Saxton
ORCID ID
Contact details
Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom
+44 (0)114 225 4414
j.m.saxton@shu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PG/2000042
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2000
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
104
Participant 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).
Recruitment start date
01/10/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom
Sponsor information
Organisation
Sheffield Hallam University (UK)
Sponsor details
City Campus
Howard Street
Sheffield
S1 1WB
United Kingdom
+44 (0)114 225 5555
liaison@shu.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK) - (Grant number: PG/2000042)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
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. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16376202
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16095931
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18226561
Publication citations
-
Results
Zwierska I, Walker RD, Choksy SA, Male JS, Pockley AG, Saxton JM, Upper- vs lower-limb aerobic exercise rehabilitation in patients with symptomatic peripheral arterial disease: a randomized controlled trial., J. Vasc. Surg., 2005, 42, 6, 1122-1130, doi: 10.1016/j.jvs.2005.08.021.
-
Results
Saxton JM, Zwierska I, Hopkinson K, Espigares E, Choksy S, Nawaz S, Walker R, Pockley AG, Effect of upper- and lower-limb exercise training on circulating soluble adhesion molecules, hs-CRP and stress proteins in patients with intermittent claudication., Eur J Vasc Endovasc Surg, 2008, 35, 5, 607-613, doi: 10.1016/j.ejvs.2007.12.007.
-
Zwierska I, Walker RD, Choksy SA, Male JS, Pockley AG, Saxton JM, Relative tolerance to upper- and lower-limb aerobic exercise in patients with peripheral arterial disease., Eur J Vasc Endovasc Surg, 2006, 31, 2, 157-163, doi: 10.1016/j.ejvs.2005.06.025.