Condition category
Circulatory System
Date applied
24/08/2006
Date assigned
27/09/2006
Last edited
04/01/2011
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

Ethics approval

Ethics approval granted by the South Sheffield Research Ethics Committee on 23/06/06 (reference number: 05/Q2305/128).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Peripheral arterial disease (intermittent claudication)

Intervention

Upper-limb aerobic exercise intervention (arm-cranking exercise training, twice per week for 12 weeks) versus usual patient care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Walking performance.

Secondary outcome measures

Changes in lower-limb circulatory function.

Overall trial start date

01/09/2006

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

31/08/2007

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

Centre for Sport and Exercise Science
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sheffield Hallam University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19388883

Publication citations

  1. Results

    Tew G, Nawaz S, Zwierska I, Saxton JM, Limb-specific and cross-transfer effects of arm-crank exercise training in patients with symptomatic peripheral arterial disease., Clin. Sci., 2009, 117, 12, 405-413, doi: 10.1042/CS20080688.

Additional files

Editorial Notes