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Single-centre, double-blinded, randomised placebo-controlled trial to determine the effect of a 12-week home-based programme of footplate neuromuscular electrical stimulation on walking capacity in people with peripheral artery disease: a protocol for the Foot-PAD trial.

作者信息

Askew Christopher David, Windsor Mark, Feka Krist, Russell Fraser Donald, Schaumberg Mia, Walker Meegan Anne, Neal Bruce, Esterman Adrian, Litewka Lucas, Golledge Jonathan

机构信息

School of Health, University of the Sunshine Coast, Sippy Downs, Queensland, Australia

Sunshine Coast Hospital and Health Service, Sunshine Coast Health Institute, Birtinya, Queensland, Australia.

出版信息

BMJ Open. 2025 Jan 25;15(1):e093162. doi: 10.1136/bmjopen-2024-093162.


DOI:10.1136/bmjopen-2024-093162
PMID:39863411
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11784211/
Abstract

INTRODUCTION: Patients with peripheral artery disease (PAD) can experience intermittent claudication, which limits walking capacity and the ability to undertake daily activities. While exercise therapy is an established way to improve walking capacity in people with PAD, it is not feasible in all patients. Neuromuscular electrical stimulation (NMES) provides a way to passively induce repeated muscle contractions and has been widely used as a therapy for chronic conditions that limit functional capacity. Preliminary trials in patients with PAD demonstrate that stimulation of the leg muscles using a footplate-NMES device can be performed without pain and may lead to significant gains in walking capacity. Studies, to date, have been small and have not been adequately controlled to account for any potential placebo effect. Therefore, the current trial will compare the effect of a 12-week programme of footplate-NMES with a placebo-control on walking capacity (6 min walking distance) and other secondary outcomes in patients with PAD. METHODS AND ANALYSIS: The Foot-PAD trial is a double-blinded, randomised placebo-controlled trial to determine the effect of a 12-week home-based programme of footplate NMES on walking capacity in people with PAD. This is a single-centre trial with numerous recruitment locations. A total of 180 participants with stable PAD and intermittent claudication will be randomly assigned (1:1 ratio) to receive either footplate-NMES (intervention condition) or footplate-placebo (control condition) for two 30 min periods each day for 12 weeks. The footplate-NMES device will deliver stimulation sufficient to induce contraction of the leg muscles and repeated plantar and dorsiflexion at the ankles. The footplate-placebo device will deliver a momentary low-intensity transient stimulation that is insufficient to induce contraction of the leg muscles. Outcomes will be assessed at baseline (week 0), mid-intervention (week 6), postintervention (week 12) and 6 weeks after the completion of the intervention (week 18). The primary outcome is walking capacity at week 12, measured as maximum walking distance during the 6 min walk test. Secondary outcomes will include pain-free walking distance during the 6 min walk test; pain-free and maximum walking time during a graded treadmill walking test; disease-specific quality of life (Intermittent Claudication Questionnaire), self-reported walking impairment (Walking Impairment Questionnaire) and accelerometer-derived physical activity levels. Exploratory outcomes will include the Ankle-Brachial Index; leg vascular function; perception of device-use experience and symptom monitoring throughout the trial using the Claudication Symptom Instrument and a pain Visual Analogue Scale. ETHICS AND DISSEMINATION: The Foot-PAD trial has received ethics approval from the Human Research Ethics Committees of Queensland Health Metro North Hospital and Health Service (78962) and the University of the Sunshine Coast (A21659). Regardless of the study outcomes, the study findings will be published in peer-reviewed scientific journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: ACTRN12621001383853.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d82/11784211/4266f647bf5e/bmjopen-15-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d82/11784211/4266f647bf5e/bmjopen-15-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d82/11784211/4266f647bf5e/bmjopen-15-1-g001.jpg

相似文献

[1]
Single-centre, double-blinded, randomised placebo-controlled trial to determine the effect of a 12-week home-based programme of footplate neuromuscular electrical stimulation on walking capacity in people with peripheral artery disease: a protocol for the Foot-PAD trial.

BMJ Open. 2025-1-25

[2]
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[6]
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[7]
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[10]
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本文引用的文献

[1]
2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

Circulation. 2024-6-11

[2]
Near-Infrared Spectroscopy During Reactive Hyperemia for the Assessment of Lower Limb Vascular Function.

J Vis Exp. 2024-3-22

[3]
Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication.

Eur J Vasc Endovasc Surg. 2024-1

[4]
Toward a Better Understanding of Muscle Microvascular Perfusion During Exercise in Patients With Peripheral Artery Disease: The Effect of Lower-Limb Revascularization.

J Endovasc Ther. 2024-2

[5]
The Association Between Contrast-Enhanced Ultrasound and Near-Infrared Spectroscopy-Derived Measures of Calf Muscle Microvascular Responsiveness in Older Adults.

Heart Lung Circ. 2021-11

[6]
Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association.

Circulation. 2021-8-31

[7]
An updated systematic review and meta-analysis of home-based exercise programs for individuals with intermittent claudication.

J Vasc Surg. 2021-12

[8]
A systematic review of exercise testing in patients with intermittent claudication: A focus on test standardisation and reporting quality in randomised controlled trials of exercise interventions.

PLoS One. 2021

[9]
Relationship between requirement to stop during a six-minute walk test and health-related quality of life, physical activity and physical performance amongst people with intermittent claudication.

Ann Vasc Surg. 2021-10

[10]
Molecular and neural adaptations to neuromuscular electrical stimulation; Implications for ageing muscle.

Mech Ageing Dev. 2021-1

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