Clinical trial NCT01822457: Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
Official title: Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Intermittent Claudication
Keywords: Peripheral vascular disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Maximum Walking Distances
timeFrame: 12 months
Secondary outcomes:
measure: Pain Free Treadmill Walking Distance
timeFrame: 12 months
measure: Disease Specific Quality of Life
timeFrame: 12 months
measure: Mood
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Healthcare Trust- St Marys
Study officials:
affiliation: Imperial College NHS Healthcare Trust
name: Ara Darzi, MD, FRCS, FRS
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College NHS Healthcare Trust
name: Nicholas J Cheshire, MD, FRCS
role: STUDY_DIRECTOR
affiliation: Imperial College NHS Healthcare Trust
name: Colin D Bicknell, MD, FRCS
role: STUDY_DIRECTOR
affiliation: Imperial College NHS Healthcare Trust
name: Celia Riga, MD, FRCS
role: STUDY_DIRECTOR
References: