NCT01822457

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Disease
• Intermittent Claudication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• Completion: 2016-08-01
• First posted: 2013-04-02
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

1 site across 1 country: United Kingdom