Condition category
Circulatory System
Date applied
20/10/2011
Date assigned
20/10/2011
Last edited
19/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sth.nhs.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24760745

Publication citations

  1. 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.

Additional files

Editorial Notes