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

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, and University of Rochester Vascular Unit (USA). 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.

After completion of routine supervised exercise classes (UK only), 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.