N/A N=37 Randomized Single-blind Supportive Care

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

Peripheral Vascular Disease · Intermittent Claudication

Bottom Line

View on ClinicalTrials.gov: NCT01822457 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Maximum Walking Distances — 147; 68 Meters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nike FuelBand (NFB) (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Dec 2015

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.