Intermittent Claudication, Peripheral Vascular Disease
Conditions
Keywords
Peripheral vascular disease
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.
Interventions
DEVICENike 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.
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Walking Distances | 12 months | Standardised treadmill test at the end of the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Free Treadmill Walking Distance | 12 months | Standardised treadmill test - first recognition of pain as reported by the patient. |
| Disease Specific Quality of Life | 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) |
| Mood | 3 months | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Control Standard follow-up | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Nike FuelBand (NFB) | Control | Total |
|---|---|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 10.3 | 70.7 Years STANDARD_DEVIATION 10.8 | 69.1 Years STANDARD_DEVIATION 10.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 18 Participants | 12 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 17 |
| other Total, other adverse events | 0 / 20 | 0 / 17 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 |
Outcome results
Primary
Maximum Walking Distances
Standardised treadmill test at the end of the study period
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nike FuelBand (NFB) | Maximum Walking Distances | 147 Meters |
| Control | Maximum Walking Distances | 68 Meters |
Secondary
Disease Specific Quality of Life
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nike FuelBand (NFB) | Disease Specific Quality of Life | 5.8 score on a scale |
| Control | Disease Specific Quality of Life | 3.3 score on a scale |
Secondary
Mood
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.
Time frame: 3 months
Population: Data not collected
Secondary
Pain Free Treadmill Walking Distance
Standardised treadmill test - first recognition of pain as reported by the patient.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nike FuelBand (NFB) | Pain Free Treadmill Walking Distance | 110 Meters |
| Control | Pain Free Treadmill Walking Distance | 44 Meters |