Contact information
Type
Scientific
Primary contact
Prof Jonathan Beard
ORCID ID
Contact details
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 (0)114 243 4343
Jonathan.d.beard@sth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10781
Study information
Scientific title
Is Nordic Pole Walking more effective than normal walking in improving walking distance in patients with intermittent claudication? A prospective randomised study
Acronym
NWP
Study hypothesis
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
National Research Ethics Service Committee Yorkshire and the Humber South Yorkshire ref: 11/YH/0100
Study design
Interventional, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/10/2011
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant 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
Recruitment start date
01/10/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
Sponsor information
Organisation
Sheffield Teaching Hospitals NHS Trust (UK)
Sponsor details
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Funder name
Private Physiotherapy Educational Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sheffield Vascular Research Fund (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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24760745
Publication citations
-
Results
Spafford C, Oakley C, Beard JD, Randomized clinical trial comparing Nordic pole walking and a standard home exercise programme in patients with intermittent claudication., Br J Surg, 2014, 101, 7, 760-767, doi: 10.1002/bjs.9519.