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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
37
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.
Imperial College NHS Healthcare Trust- St Marys
London, United Kingdom
Maximum Walking Distances
Standardised treadmill test at the end of the study period
Time frame: 12 months
Pain Free Treadmill Walking Distance
Standardised treadmill test - first recognition of pain as reported by the patient.
Time frame: 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)
Time frame: 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.
Time frame: 3 months
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