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Randomized Controlled Trial
. 2024 Aug 14;24(1):683.
doi: 10.1186/s12877-024-05271-z.

Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial

Binoy Kumaran  1 , Darren Targett  2 , Tim Watson  3
Affiliations
Randomized Controlled Trial

Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial

Binoy Kumaran et al. BMC Geriatr. .

Abstract

Introduction: Lower leg pain and symptoms, and poor leg circulation are common in older adults. These can significantly affect their function and quality of life. Neuromuscular electrical stimulation (NMES) applied via the feet as 'foot NMES' activates the leg musculovenous pump. This study investigated the effects of foot NMES administered at home using Revitive® among community-dwelling older adults with lower leg pain and/or other lower leg symptoms such as cramps, or sensations of tired, aching, and heavy feeling legs.

Methods: A randomised placebo-controlled study with three groups (2 NMES, 1 Sham) and three assessments (baseline, week 8, week 12 follow-up) was carried out. Self-reported function using Canadian occupational performance measure (COPM), leg pain, overall leg symptoms score (heaviness, tiredness, aching, or cramps), and ankle blood flow were assessed. Analysis of covariance (ANCOVA) and logistic regression were used to compare the groups. Statistical significance was set at p < 0.05 (two-sided 5%).

Results: Out of 129 participants enrolled, 114 completed the study. The improvement in all outcomes were statistically significant for the NMES interventions compared to Sham at both week 8 (p < 0.01) and week 12 (p < 0.05). The improvement in COPM met the minimal clinically important difference (MCID) for the NMES interventions compared to Sham at both week 8 (p < 0.005) and week 12 (p < 0.05). Improvement in leg pain met MCID at week 8 compared to Sham (p < 0.05). Ankle blood flow increased approximately 3-fold during treatment compared to Sham. Compliance with the interventions was high and no device-related adverse events were reported.

Conclusions: The home-based foot NMES is safe, and significantly improved self-reported function, leg pain and overall leg symptoms, and increased ankle blood flow compared to a Sham among older adults.

Trial registration: The trial was prospectively registered in ISRCTN on 17/06/2019 with registration number ISRCTN10576209. It can be accessed at https://www.isrctn.com/ISRCTN10576209 .

Keywords: Blood flow; Leg pain; Leg symptoms; Neuromuscular electrical stimulation (NMES); Self-reported function.

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Conflict of interest statement

The first author (BK) declares no competing interests. DT is an independent expert acting as a statistical consultant for Actegy Limited for this study (funder of the trial and manufacturer of Revitive®). TW has expert consultancy contract with Actegy Limited, which is unrelated to this study.

Figures

Fig. 1
Fig. 1
Revitive® device and the study structure
Fig. 2
Fig. 2
The CONSORT diagram
See this image and copyright information in PMC

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References

    1. von Berens Å, Fielding RA, Gustafsson T, Kirn D, Laussen J, Nydahl M, et al. Effect of exercise and nutritional supplementation on health-related quality of life and mood in older adults: the VIVE2 randomized controlled trial. BMC Geriatr. 2018;18:1–8. - PMC - PubMed
    1. Puente-Fernández J, Larumbe-Zabala E, Jiménez A, Liguori G, Rossato CJL, Mayo X, et al. No impact of combining multi-ingredient supplementation with exercise on body composition and physical performance, in healthy middle-aged and older adults: a systematic review and meta-analysis. Exp Gerontol. 2023;172:112079. 10.1016/j.exger.2022.112079 - DOI - PubMed
    1. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. 2016 AHA/ACC Guideline on the management of patients with Lower Extremity Peripheral Artery Disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice guidelines. Circulation. 2017;135(12):e686–725. - PMC - PubMed
    1. McDermott MM, Mehta S, Greenland P. Exertional leg symptoms other than intermittent claudication are common in peripheral arterial disease. Arch Intern Med. 1999;159(4):387–92. 10.1001/archinte.159.4.387 - DOI - PubMed
    1. Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, et al. Lower extremity peripheral artery disease: contemporary epidemiology, management gaps, and future directions: A Scientific Statement from the American Heart Association. Circulation. 2021;144(9):e171–91. 10.1161/CIR.0000000000001005 - DOI - PMC - PubMed

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