The effects of upper-limb aerobic exercise training on walking performance and lower limb circulatory function in patients with peripheral arterial disease

ISRCTN	ISRCTN50394448
DOI	https://doi.org/10.1186/ISRCTN50394448
Protocol serial number	N/A
Sponsor	Sheffield Hallam University (UK)
Funder	Sheffield Hallam University (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr John Saxton
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval granted by the South Sheffield Research Ethics Committee on 23/06/06 (reference number: 05/Q2305/128).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Walking performance.
Key secondary outcome measure(s)	Changes in lower-limb circulatory function.
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	31/08/2007

Centre for Sport and Exercise Science

Sheffield
S10 2BP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/09/2009		Yes	No