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

This study is currently recruiting participants.
Verified March 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01822457
First received: February 19, 2013
Last updated: August 2, 2013
Last verified: March 2013
  Purpose

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.

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.


Condition Intervention
Peripheral Vascular Disease
Intermittent Claudication
Device: Nike FuelBand (NFB)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Maximum walking distances [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Standardised treadmill test


Secondary Outcome Measures:
  • Pain free treadmill walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Standardised treadmill test

  • Disease specific quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessed using VascuQol Questionnaire score

  • Mood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Assessed using the Hospital Anxiety and Depression Scale score,


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822457

Contacts
Contact: Pasha Normahani, BSc, MBBS Pn106@imperial.ac.uk
Contact: Richard M Kwasnicki, BSc rmk107@imperial.ac.uk

Locations
United Kingdom
Imperial College NHS Healthcare Trust- St Marys Recruiting
London, United Kingdom, W21NY
Contact: Pasha Normahani, BSc, MBBS       Pn106@imperial.ac.uk   
Sponsors and Collaborators
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: Laura Gunn, PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01822457     History of Changes
Other Study ID Numbers: 12 LO 1896
Study First Received: February 19, 2013
Last Updated: August 2, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on April 15, 2014