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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Vascular Disease Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nike FuelBand (NFB)

Patients will receive a Nike Fuel Band to encourage exercise.

Group Type EXPERIMENTAL

Nike FuelBand (NFB)

Intervention Type 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.

control

Standard follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No