Trial Outcomes & Findings for Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial (NCT NCT01822457)

Results Overview

Standardised treadmill test at the end of the study period

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

12 months

Results posted on

2020-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Nike FuelBand (NFB) Patients will receive a Nike Fuel Band to encourage exercise. 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.	Control Standard follow-up
Overall Study STARTED	20	17
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nike FuelBand (NFB) n=20 Participants Patients will receive a Nike Fuel Band to encourage exercise. 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.	Control n=17 Participants Standard follow-up	Total n=37 Participants Total of all reporting groups
Age, Continuous	67.8 Years STANDARD_DEVIATION 10.3 • n=20 Participants	70.7 Years STANDARD_DEVIATION 10.8 • n=17 Participants	69.1 Years STANDARD_DEVIATION 10.4 • n=37 Participants
Sex: Female, Male Female	2 Participants n=20 Participants	5 Participants n=17 Participants	7 Participants n=37 Participants
Sex: Female, Male Male	18 Participants n=20 Participants	12 Participants n=17 Participants	30 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Standardised treadmill test at the end of the study period

Outcome measures

Outcome measures
Measure	Nike FuelBand (NFB) n=16 Participants Patients will receive a Nike Fuel Band to encourage exercise. 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.	Control n=12 Participants Standard follow-up
Maximum Walking Distances	147 Meters Interval 135.0 to 405.0	68 Meters Interval 40.0 to 75.0

SECONDARY outcome

Timeframe: 12 months

Standardised treadmill test - first recognition of pain as reported by the patient.

Outcome measures

Outcome measures
Measure	Nike FuelBand (NFB) n=16 Participants Patients will receive a Nike Fuel Band to encourage exercise. 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.	Control n=12 Participants Standard follow-up
Pain Free Treadmill Walking Distance	110 Meters Interval 55.0 to 200.0	44 Meters Interval 30.0 to 75.0

SECONDARY outcome

Timeframe: 12 months

Assessed using VascuQol (Vascular Quality of life) Questionnaire score, range from 0 to 24, and higher value indicates a better health status. Each question has a four-point response scale (1 most problems - 4 no problems)

Outcome measures

Outcome measures
Measure	Nike FuelBand (NFB) n=16 Participants Patients will receive a Nike Fuel Band to encourage exercise. 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.	Control n=12 Participants Standard follow-up
Disease Specific Quality of Life	5.8 score on a scale Interval 5.0 to 7.0	3.3 score on a scale Interval 2.4 to 4.6

SECONDARY outcome

Timeframe: 3 months

Population: Data not collected

Assessed using the Hospital Anxiety and Depression Scale score, participants reply that is closest to how they have been feeling in the past months. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Score 0 to 3, 3 - Most of the time, 0 - Not at all.

Outcome measures

Outcome data not reported

Adverse Events

Nike FuelBand (NFB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Pasha Normahani

Imperial Vascular Unit

Phone: +44 (0) 20 759 48904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place