N/A
Completed N=37
Effect of Nike FuelBand on Exercise and Function in Claudicants; a Randomised Controlled Trial
Peripheral vascular disease · Intermittent Claudication
Source: ClinicalTrials.gov NCT01822457 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Maximum Walking Distances — 147; 68 Meters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Walking Distances |
147; 68 | — |
| SECONDARY Pain Free Treadmill Walking Distance |
110; 44 | — |
| SECONDARY Disease Specific Quality of Life |
5.8; 3.3 | — |
| SECONDARY Mood |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01822457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.