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
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
-
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.