Peripheral Vascular DiseaseNCT01822457
Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
A study testing Nike FuelBand (NFB) in people with Peripheral Vascular Disease and Intermittent Claudication, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This is a randomised controlled study of patients suffering from intermittent claudication (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise levels and quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Vascular Disease, Intermittent Claudication
- What is being tested?
- Nike FuelBand (NFB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80
- Referred to vascular rehabilitation service at St Marys Hospital (UK)
- IC involving the calf muscles
- Clinical and duplex investigations indicate Superficial Femoral Artery stenosis or occlusion
Who cannot join
- Clinical and duplex investigations indicate iliac disease
- Major joint disease in lower limb or lumbar spine/entrapment syndrome
- Significant cardiopulmonary limitations (NYHA>1)
- Maximum walking distance >500m
- Hospital inpatient/ living in a care home
- *Unfamiliarity with required technology
Show all 12Show fewer
- History of dementia
- Unable to mobilize independently (does not include walking aids)
- IC not limiting factor of mobilization, limited by other medical problems
- Unable to attend supervised exercise programme
- Patient owns or uses any type of activity monitor
- Uses a walking frame *Patients should be able to use the NFB technology with minimal assistance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College NHS Healthcare Trust- St Marys
London, W21NY
About this study
This is a randomised controlled study of patients suffering from intermittent claudication (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise levels and quality of life.
Read the detailed description
IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by narrowing or blockage of the blood vessels in the legs.
The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides estimates of the number of steps taken and the amount of distance covered each day.
This study will be conducted over a period of 18 months at Imperial College Trust's vascular outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to consider participating. Participants will receive routine diagnostic work up with the addition of having their walking distances measured on a lab treadmill. They will also have their functional status and mood assessed using a questionnaire. These assessments will be carried out a total of five times over the course of the study. Patients will not need to make any additional visits to hospital.
Patients will be randomly allocated to either the NFB group or the control group. Patients in the NFB group will be given a FuelBand with instructions on how to use it. All patients will be given routine instructions on maintaining activity and target daily walking distances. Target walking distances will be programmed into the NFB. Patients in the NFB group will be asked to record estimates of how far they have walked each day directly from their band. All patients will be contacted by telephone at a pre-arranged time to collect recordings.
Patients will be followed up at their routine 3-month follow up appointment and additionally at 6 and 12 months.
- Being tested
- Nike FuelBand (NFB)
- Keywords
- Peripheral vascular disease
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nike FuelBand (NFB)Device
The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface.
| Study group | Role | What they receive |
|---|---|---|
| Nike FuelBand (NFB) | Experimental | Patients will receive a Nike Fuel Band to encourage exercise. Receives: Device: Nike FuelBand (NFB) |
| control | No intervention | Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Walking Distances
Standardised treadmill test at the end of the study period
Measured: 12 months
Secondary outcomes (3)
Pain Free Treadmill Walking Distance
Standardised treadmill test - first recognition of pain as reported by the patient.
Measured: 12 months
Disease Specific Quality of Life
Assessed using VascuQol (Vascular Quality of life) Questionnaire score, range from 0 to 24, and higher value indicates a better health status.
Each question has a four-point response scale (1 most problems - 4 no problems)
Measured: 12 months
Mood
Assessed using the Hospital Anxiety and Depression Scale score, participants reply that is closest to how they have been feeling in the past months. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Score 0 to 3, 3 - Most of the time, 0 - Not at all.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara Darzi, MD, FRCS, FRS, Principal investigator, Imperial College NHS Healthcare TrustNicholas J Cheshire, MD, FRCS, Study director, Imperial College NHS Healthcare TrustColin D Bicknell, MD, FRCS, Study director, Imperial College NHS Healthcare TrustCelia Riga, MD, FRCS, Study director, Imperial College NHS Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822457
- Sponsor's protocol ID
- 12 LO 1896
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2013
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01822457
- Acronym / sponsor ID
- 12 LO 1896
- Keywords
- Peripheral vascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised controlled study of patients suffering from intermittent claudication (IC), to assess the impact of wearing a Nike FuelBand (NFB) on walking distances, exercise levels and quality of life.
Detailed description
IC manifests as pain in the calf, thigh or buttock muscles when walking. It is caused by narrowing or blockage of the blood vessels in the legs.
The NFB is a discrete wristband with a built-in accelerometer to measure motion. It provides estimates of the number of steps taken and the amount of distance covered each day.
This study will be conducted over a period of 18 months at Imperial College Trust's vascular outpatients service. Patients that meet the inclusion/exclusion criteria will be asked to consider participating. Participants will receive routine diagnostic work up with the addition of having their walking distances measured on a lab treadmill. They will also have their functional status and mood assessed using a questionnaire. These assessments will be carried out a total of five times over the course of the study. Patients will not need to make any additional visits to hospital.
Patients will be randomly allocated to either the NFB group or the control group. Patients in the NFB group will be given a FuelBand with instructions on how to use it. All patients will be given routine instructions on maintaining activity and target daily walking distances. Target walking distances will be programmed into the NFB. Patients in the NFB group will be asked to record estimates of how far they have walked each day directly from their band. All patients will be contacted by telephone at a pre-arranged time to collect recordings.
Patients will be followed up at their routine 3-month follow up appointment and additionally at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nike FuelBand (NFB) | Experimental | Device: Nike FuelBand (NFB)Patients will receive a Nike Fuel Band to encourage exercise. |
| control | No intervention | –Standard follow-up |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-80
- Referred to vascular rehabilitation service at St Marys Hospital (UK)
- IC involving the calf muscles
- Clinical and duplex investigations indicate Superficial Femoral Artery stenosis or occlusion
Key exclusion criteria (12 listed)
- Clinical and duplex investigations indicate iliac disease
- Major joint disease in lower limb or lumbar spine/entrapment syndrome
- Significant cardiopulmonary limitations (NYHA>1)
- Maximum walking distance >500m
- Hospital inpatient/ living in a care home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nike FuelBand (NFB)The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface. | Device | Nike FuelBand (NFB) |
Primary outcome
Maximum Walking Distances
Time frame: 12 months
Standardised treadmill test at the end of the study period
3 secondary outcomes
Pain Free Treadmill Walking Distance
Time frame: 12 months
Disease Specific Quality of Life
Time frame: 12 months
Mood
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ara Darzi, MD, FRCS, FRS principal investigator
Imperial College NHS Healthcare Trust
Nicholas J Cheshire, MD, FRCS study director
Imperial College NHS Healthcare Trust
Colin D Bicknell, MD, FRCS study director
Imperial College NHS Healthcare Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nike FuelBand (NFB) in people with Peripheral Vascular Disease and Intermittent Claudication, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Walking Distances (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.