Is Nordic Pole Walking (NWP) more effective than normal walking in intermittent claudication patients?
| ISRCTN | ISRCTN78168304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78168304 |
| Secondary identifying numbers | 10781 |
- 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
Scientific
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 243 4343 |
|---|---|
| Jonathan.d.beard@sth.nhs.uk |
Study information
| Study design | Interventional, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/10/2011 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
| Website | http://www.sth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Charity
British Heart Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Private Physiotherapy Educational Foundation (UK)
No information available
Sheffield Vascular Research Fund (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2014 | Yes | No |
