Is Nordic Pole Walking (NWP) more effective than normal walking in intermittent claudication patients?

ISRCTN	ISRCTN78168304
DOI	https://doi.org/10.1186/ISRCTN78168304
Protocol serial number	10781
Sponsor	Sheffield Teaching Hospitals NHS Trust (UK)
Funders	British Heart Foundation (UK), Private Physiotherapy Educational Foundation (UK), Sheffield Vascular Research Fund (UK)

Submission date: 20/10/2011
Registration date: 20/10/2011
Last edited: 19/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jonathan Beard
Scientific

Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 243 4343
Email	Jonathan.d.beard@sth.nhs.uk

Study information

Primary study design	Interventional
Study design	Interventional, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Is Nordic Pole Walking more effective than normal walking in improving walking distance in patients with intermittent claudication? A prospective randomised study
Study acronym	NWP
Study objectives	Patients with narrowed or blocked arteries in their legs, due to smoking and/or high cholesterol, often suffer from cramping pains in their calf muscles when they walk. This is due to poor blood flow and is called intermittent claudication. Regular exercise can help and supervised classes in a gym provide the most benefit. However, these classes are expensive to run, take time to work and many patients stop coming after a while. Walking with cross country ski (Nordic) poles is a very popular activity in Scandinavia as they improve fitness. A recent study in Sheffield has found that Nordic Pole Walking immediately helps patients with Intermittent Claudication to walk further with less pain, without any feeling any more tired. This second study will look at whether this immediate benefit is improved by the minimally supervised use of poles over 12 weeks. Patients with intermittent claudication wll be recruited from the vascular outpatient clinics after being provided with information about the study and agreeing to participate. Patients will be randomly allocated to a group who use poles or who receive normal advice to exercise regularly. We will use weekly diaries and pedometers to record the amount of exercise taken. Patients will be invited to attend the gym every month to see how much their walking and fitness has improved.
Ethics approval(s)	National Research Ethics Service Committee Yorkshire and the Humber South Yorkshire ref: 11/YH/0100
Health condition(s) or problem(s) studied	Cardiovascular disease
Intervention	The only intervention we use is a pair of walking poles..randomly allocated to each patient. Each patient is followed for 12 weeks. Ankle Brachial Pressure Index (ABPI) measured before and after each visit: 1. Heart Rate 2. Post test heart rate taken every 2 mins until back to resting state. Research nurse gives patient information sheet. They fill in a tear off strip and return to investigators if they are happy with it. Last visit, base line tests again.Patient diary/pedometer check, weeks 4,8,12.Phone call to arrange visit 0, Investigator phones patient to arrange initial visit for consent and base line data and tests.results notification, Written thanks to patients giving them the results in lay language. Supervision Phonecalls, Weeks 1,2,3,5,6,7,9,10,11.; Visit 0, Base line tests: Weight, heightm resting heart rate, ABPI using Doppler, max walking distance, claudication distance, Borg pain scale, and Borg RPE. Consent Teach NWP technique Familiarisation with heart rate monitor strap and watch and pedometer.; Walking test with NWP, Same as walking test. Walking tests, Weeks 0,4,8,12. HR, ABPI, CD, MWD, Borg Pain and RPE
Intervention type	Other
Primary outcome measure(s)	Is the technique of using NPW is more effective in improving walking distance than normal walking? Measured on each patient at week 0 and 12. At week 4, and 8 we will also be recording the patient's progress using the primary outcome measures, distance walked, level of perceived exertion and level of pain at CD and MWD.
Key secondary outcome measure(s)	Compare compliance, the cardiovascular training effect, ABPI and any weight loss. Measured on each patient at week 0 and 12. At week 4, and 8 we will also be recording the patient's progress using the primary outcome measures, distance walked, level of perceived exertion and level of pain at CD and MWD.
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients must have stable intermittent claudication due to peripheral arterial disease of more than 6/12 duration of symptoms 2. A resting ABPI of <0.9, which is unsuitable for revascularisation 3. Patient has not had a revascularisation procedure in the last six months 4. Level(s) of disease and unsuitability for revascularisation will have been previously determined by duplex ultrasound and/or magnetic resonance (MR) arteriography. 5. Patients must not have other conditions that could limit their walking distance (e.g. breathlessness or severe osteoarthrosis) or the ability to hold poles 6. Male and female participants 7. Aged between 50 - 100 years
Key exclusion criteria	1. Patients with intermittent claudication due to peripheral arterial disease of less than 6/12 duration of symptoms 2. A resting ABPI of >0.9, which is suitable for revascularisation 3. Patient has had a revascularisation procedure in the last six months 4. Level(s) of disease and unsuitability for revascularisation will have been previously determined by duplex ultrasound and/or MR arteriography 5. Patients with other conditions that could limit their walking distance (e.g. breathlessness or severe osteoarthrosis) or problems using their hands which might affect the ability to hold poles
Date of first enrolment	01/10/2011
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Northern General Hospital

Sheffield
S5 7AU
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes