A comparison of upper-limb and lower-limb exercise training in patients with intermittent claudication (IC)

ISRCTN	ISRCTN76180797
DOI	https://doi.org/10.1186/ISRCTN76180797
Protocol serial number	PG/2000042
Sponsor	Sheffield Hallam University (UK)
Funder	British Heart Foundation (UK) - (Grant number: PG/2000042)

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

Phone	+44 (0)114 225 4414
Email	j.m.saxton@shu.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Walking performance (claudication distance and maximum walking distance).
Key secondary outcome measure(s)	1. Upper- and lower-limb aerobic exercise capacity 2. Disease-specific and generic quality of life measures 3. Blood markers of cardiovascular disease risk
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	104
Key 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 patients 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.
Key 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).
Date of first enrolment	01/10/2000
Date of final enrolment	31/12/2005

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	Peer reviewed?	Patient-facing?
Results article	results	01/12/2005	Yes	No
Results article	results	01/02/2006	Yes	No
Results article	results	01/05/2008	Yes	No