Status:

COMPLETED

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

Lead Sponsor:

Imperial College London

Conditions:

Peripheral Vascular Disease

Intermittent Claudication

Eligibility:

All Genders

40-80 years

Phase:

NA

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...

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 accele...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2016

Estimated Enrollment :

37 Patients enrolled

Trial Details

Trial ID

NCT01822457

Start Date

August 1 2013

End Date

August 1 2016

Last Update

February 17 2020

Active Locations (1)

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Imperial College NHS Healthcare Trust- St Marys

London, United Kingdom, W21NY