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

Imperial College London

Status

Completed

Conditions

Peripheral Vascular Disease

Intermittent Claudication

Treatments

Device: Nike FuelBand (NFB)

Study type

Interventional

Funder types

Other

Identifiers

NCT01822457

12 LO 1896

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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