NCT01822457

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

February 19, 2013

Results QC Date

February 21, 2019

Last Update Submit

February 13, 2020

Conditions

Peripheral Vascular DiseaseIntermittent Claudication

Keywords

Peripheral vascular disease

Outcome Measures

Primary Outcomes (1)

  • Maximum Walking Distances

    Standardised treadmill test at the end of the study period

    12 months

Secondary Outcomes (3)

  • Pain Free Treadmill Walking Distance

    12 months

  • Disease Specific Quality of Life

    12 months

  • Mood

    3 months

Study Arms (2)

Nike FuelBand (NFB)

EXPERIMENTAL

Patients will receive a Nike Fuel Band to encourage exercise.

Device: Nike FuelBand (NFB)

control

NO INTERVENTION

Standard follow-up

Interventions

Nike FuelBand (NFB)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.

Nike FuelBand (NFB)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College NHS Healthcare Trust- St Marys

London, W21NY, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Vascular DiseasesIntermittent Claudication

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mr Pasha Normahani
Organization
Imperial Vascular Unit
pnormahani@gmail.com
+44 (0) 20 759 48904

Study Officials

  • Ara Darzi, MD, FRCS, FRS

    Imperial College NHS Healthcare Trust

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

April 2, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

August 1, 2016

Last Updated

February 17, 2020

Results First Posted

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)