Condition category
Circulatory System
Date applied
24/08/2005
Date assigned
25/10/2005
Last edited
28/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 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.

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

http://www.shu.ac.uk

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

foundation

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes