Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01822457
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : August 11, 2016
Information provided by (Responsible Party):
Imperial College London

Brief 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.

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.

Condition or disease Intervention/treatment
Peripheral Vascular Disease Intermittent Claudication Device: Nike FuelBand (NFB)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
Study Start Date : August 2013
Primary Completion Date : December 2015
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nike FuelBand (NFB)
Patients will receive a Nike Fuel Band to encourage exercise.
Device: 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.
No Intervention: control
Standard follow-up

Primary Outcome Measures :
  1. Maximum walking distances [ Time Frame: 3 months ]
    Standardised treadmill test

Secondary Outcome Measures :
  1. Pain free treadmill walking distance [ Time Frame: 3 months ]
    Standardised treadmill test

  2. Disease specific quality of life [ Time Frame: 3 months ]
    Assessed using VascuQol Questionnaire score

  3. Mood [ Time Frame: 3 months ]
    Assessed using the Hospital Anxiety and Depression Scale score,

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01822457

United Kingdom
Imperial College NHS Healthcare Trust- St Marys
London, United Kingdom, W21NY
Sponsors and Collaborators
Imperial College London
Principal Investigator: Ara Darzi, MD, FRCS, FRS Imperial College NHS Healthcare Trust
Study Director: Nicholas J Cheshire, MD, FRCS Imperial College NHS Healthcare Trust
Study Director: Colin D Bicknell, MD, FRCS Imperial College NHS Healthcare Trust
Study Director: Celia Riga, MD, FRCS Imperial College NHS Healthcare Trust

Responsible Party: Imperial College London Identifier: NCT01822457     History of Changes
Other Study ID Numbers: 12 LO 1896
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Cardiovascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms