Neuromuscular Electrical Stimulation and Action Observation for Healthy Aging

NCT07297381 | Active Not Recruiting

• 1 other identifier: 100008-2023-AB-PRIN_Bando2022
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is associated with a decline in muscle strength and the functionality of the perceptual structures involved in proprioception. This decline results in a gradual loss of autonomy in daily activities. Neuromuscular electrical stimulation (NMES) has been shown to be an effective technique in limiting the decline in strength. Action observation (AO) is a cognitive technique, which has been shown to improve motor performance, especially when combined with peripheral stimulation. The purpose of this study is to evaluate whether a self-administered, home-based intervention combining NMES and AO improves upper limb muscle strength and proprioceptive abilities in healthy elderly individuals. Participants within the age range of 65-85 years will be recruited for this study. The intervention is scheduled to span a duration of four weeks, encompassing three treatment sessions per week. Participants will be randomly divided into three groups: NMES, AO, and AO-NMES. Assessments will be performed before and immediately after the intervention. They will include muscle strength evaluation (handgrip strength, maximal isometric force of the biceps, bench press power), and perceptual evaluation (weight discrimination during an AO task, weight judgment tasks). This study may suggest an original approach, cost-effective approach to mitigate the effects of physiological aging on muscle and sensorimotor function, with potential applications for frail populations, unable or unmotivated to perform conventional physical activity.

Conditions

Aging, Healthy

Keywords

aging; physical fitness; strength; weight estimation

Outcome Measures

Primary Outcomes (2)

• Estimated maximal power

  Power expressed while performing a bench press exercise. This will be evaluated during the "Strength and power assessment "

  Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

• Maximal isometric strength

  Maximal isometric strength expressed during a isometric curl with the upper limbs. This will be evaluated during "Strength and power assessment "

  Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

Secondary Outcomes (2)

• Error in the estimation of box weigth

  Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

• Just noticeble difference (JND)

  Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

Study Arms (3)

Action Observation - Neuromuscular Electrical Stimulation

EXPERIMENTAL

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing movements of activity of daily living. At the end of the warm-up phase, the exercise phase will be administered at functional threshold (the minimum intensity required for a complete arm flexion or at maximal tolerated intensity (f=100Hz, t=400 μs).

Combination Product: Action Observation - Neuromuscular Electrical Stimulation

Action Observation

ACTIVE COMPARATOR

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing movements of activity of daily living. At the end of the warm-up phase, participants will receive a NMES sham treatment (f=5Hz, t=100 μs) delivered at sensory threshold, known to be ineffective in increasing muscle strength.

Combination Product: Action Observation

Neuromuscular electrical stimulation

ACTIVE COMPARATOR

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing different landscapes. At the end of the warm-up phase, the exercise phase will be administered at functional threshold (the minimum intensity required for a complete arm flexion or at maximal tolerated intensity (f=100Hz, t=400 μs).

Combination Product: Neuromuscular Electrical Stimulation

Interventions

Action Observation - Neuromuscular Electrical Stimulation COMBINATION_PRODUCT

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing movements of activity of daily living. At the end of the warm-up phase, the exercise phase will be administered at functional threshold (the minimum intensity required for a complete arm flexion or at maximal tolerated intensity (f=100Hz, t=400 μs).

Action Observation - Neuromuscular Electrical Stimulation

Action Observation COMBINATION_PRODUCT

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing movements of activity of daily living. At the end of the warm-up phase, participants will receive a NMES sham treatment (f=5Hz, t=100 μs) delivered at sensory threshold, known to be ineffective in increasing muscle strength.

Action Observation

Neuromuscular Electrical Stimulation COMBINATION_PRODUCT

During the warm-up phase, the NMES will be set with a frequency of 50 Hz and a pulse duration at 400 μs and the intensity at motor threshold. Meanwhile participants will observe video showing different landscapes. At the end of the warm-up phase, the exercise phase will be administered at functional threshold (the minimum intensity required for a complete arm flexion or at maximal tolerated intensity (f=100Hz, t=400 μs).

Neuromuscular electrical stimulation

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• sedenteary peole

You may not qualify if:

• neurological or psychiatric disorders
• fractures within the past six months
• orthopedic or musculoskeletal impairments
• uncontrolled hypertension
• regular resistance training (at least once per week)
• participation in competitive sports

Sponsors & Collaborators

• Ambra Bisio: lead
• Universita degli Studi di Genova: collaborator

Study Sites (1)

University of Genova

Genoa, Liguria, 16132, Italy

Location

Related Publications (13)

• Albergoni A, Biggio M, Faelli E, Pesce A, Ruggeri P, Avanzino L, Bove M, Bisio A. Sensorimotor expertise influences perceptual weight judgments during observation of a sport-specific gesture. Front Sports Act Living. 2023 Jun 22;5:1148812. doi: 10.3389/fspor.2023.1148812. eCollection 2023.

  PMID: 37426895 BACKGROUND

• Albergoni A, Biggio M, Faelli E, Ruggeri P, Avanzino L, Bove M, Bisio A. Aging deteriorates the ability to discriminate the weight of an object during an action observation task. Front Aging Neurosci. 2023 Aug 7;15:1216304. doi: 10.3389/fnagi.2023.1216304. eCollection 2023.

  PMID: 37609031 BACKGROUND

• Alcazar J, Guadalupe-Grau A, Garcia-Garcia FJ, Ara I, Alegre LM. Skeletal Muscle Power Measurement in Older People: A Systematic Review of Testing Protocols and Adverse Events. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):914-924. doi: 10.1093/gerona/glx216.

  PMID: 29309534 BACKGROUND

• Alcazar J, Rodriguez-Lopez C, Ara I, Alfaro-Acha A, Manas-Bote A, Guadalupe-Grau A, Garcia-Garcia FJ, Alegre LM. The Force-Velocity Relationship in Older People: Reliability and Validity of a Systematic Procedure. Int J Sports Med. 2017 Dec;38(14):1097-1104. doi: 10.1055/s-0043-119880. Epub 2017 Nov 10.

  PMID: 29126339 BACKGROUND

• Iglesias-Soler E, Mayo X, Rial-Vazquez J, Morin-Jimenez A, Aracama A, Guerrero-Moreno JM, Jaric S. Reliability of force-velocity parameters obtained from linear and curvilinear regressions for the bench press and squat exercises. J Sports Sci. 2019 Nov;37(22):2596-2603. doi: 10.1080/02640414.2019.1648993. Epub 2019 Jul 28.

  PMID: 31354059 BACKGROUND

• Insausti-Delgado A, Lopez-Larraz E, Omedes J, Ramos-Murguialday A. Intensity and Dose of Neuromuscular Electrical Stimulation Influence Sensorimotor Cortical Excitability. Front Neurosci. 2021 Jan 15;14:593360. doi: 10.3389/fnins.2020.593360. eCollection 2020.

  PMID: 33519355 BACKGROUND

• Vivodtzev I, Debigare R, Gagnon P, Mainguy V, Saey D, Dube A, Pare ME, Belanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-725. doi: 10.1378/chest.11-0839. Epub 2011 Nov 23.

  PMID: 22116795 BACKGROUND

• O'Connor D, Brennan L, Caulfield B. The use of neuromuscular electrical stimulation (NMES) for managing the complications of ageing related to reduced exercise participation. Maturitas. 2018 Jul;113:13-20. doi: 10.1016/j.maturitas.2018.04.009. Epub 2018 Apr 25.

  PMID: 29903643 BACKGROUND

• Maffiuletti NA, Gondin J, Place N, Stevens-Lapsley J, Vivodtzev I, Minetto MA. Clinical Use of Neuromuscular Electrical Stimulation for Neuromuscular Rehabilitation: What Are We Overlooking? Arch Phys Med Rehabil. 2018 Apr;99(4):806-812. doi: 10.1016/j.apmr.2017.10.028. Epub 2017 Dec 9.

  PMID: 29233625 BACKGROUND

• Langeard A, Bigot L, Chastan N, Gauthier A. Does neuromuscular electrical stimulation training of the lower limb have functional effects on the elderly?: A systematic review. Exp Gerontol. 2017 May;91:88-98. doi: 10.1016/j.exger.2017.02.070. Epub 2017 Feb 17.

  PMID: 28216413 BACKGROUND

• Bisio A, Avanzino L, Biggio M, Ruggeri P, Bove M. Motor training and the combination of action observation and peripheral nerve stimulation reciprocally interfere with the plastic changes induced in primary motor cortex excitability. Neuroscience. 2017 Apr 21;348:33-40. doi: 10.1016/j.neuroscience.2017.02.018. Epub 2017 Feb 15.

  PMID: 28214579 BACKGROUND

• Bisio A, Avanzino L, Lagravinese G, Biggio M, Ruggeri P, Bove M. Spontaneous movement tempo can be influenced by combining action observation and somatosensory stimulation. Front Behav Neurosci. 2015 Aug 21;9:228. doi: 10.3389/fnbeh.2015.00228. eCollection 2015.

  PMID: 26441565 BACKGROUND

• Bisio A, Avanzino L, Gueugneau N, Pozzo T, Ruggeri P, Bove M. Observing and perceiving: A combined approach to induce plasticity in human motor cortex. Clin Neurophysiol. 2015 Jun;126(6):1212-1220. doi: 10.1016/j.clinph.2014.08.024. Epub 2014 Oct 2.

  PMID: 25454343 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 22, 2025
• Study Start: November 2, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)