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.

Study Overview

• Status: Completed
• Conditions: Intermittent Claudication; Peripheral Vascular Disease
• Intervention / Treatment: Device: Nike FuelBand (NFB)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W21NY
    • Imperial College NHS Healthcare Trust- St Marys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Walking Distances	Standardised treadmill test at the end of the study period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Free Treadmill Walking Distance	Standardised treadmill test - first recognition of pain as reported by the patient.	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)	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.	3 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (ESTIMATE): April 2, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Peripheral vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 12 LO 1896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No