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
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
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	Walking performance.
Secondary outcome measures	Changes in lower-limb circulatory function.
Overall study start date	01/09/2006
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	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

Sheffield Hallam University (UK)
University/education

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

"ROR"	https://ror.org/019wt1929

University/education

Sheffield Hallam University (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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