Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01822457|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : August 11, 2016
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 or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease Intermittent Claudication||Device: Nike FuelBand (NFB)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||August 2016|
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
- Maximum walking distances [ Time Frame: 3 months ]Standardised treadmill test
- Pain free treadmill walking distance [ Time Frame: 3 months ]Standardised treadmill test
- Disease specific quality of life [ Time Frame: 3 months ]Assessed using VascuQol Questionnaire score
- Mood [ Time Frame: 3 months ]Assessed using the Hospital Anxiety and Depression Scale score,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822457
|Imperial College NHS Healthcare Trust- St Marys|
|London, United Kingdom, W21NY|
|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|