Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes

NCT06082297 | Completed

• 1 other identifier: TTE_PVV_1_vs_36_Hz
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study aimed to compare the effect of different C-LI-NMES frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

Conditions

Hemodynamic Instability; Pain

Keywords

Neuromuscular electrical stimulation; Hemodynamics; Physical inactivity

Outcome Measures

Primary Outcomes (4)

• Peak venous velocity (PVV)

  Peak venous velocity (centimeters per second) will be assesed by Doppler ultrasound of in the popliteal vein

  Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

• Time averaged mean velocity (TAMV)

  Time averaged mean velocity will be assesed by Doppler ultrasound in the popliteal vein (centimeters per second)

  Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

• Average duration of blood pulse (ADBP)

  Average duration of blood pulse will be assesed by Doppler ultrasound in the popliteal vein (seconds)

  Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

• Ejection volume (EV)

  Ejection volume of blood will be assesed by Doppler ultrasound in the popliteal vein (milliliters)

  Day 1 at rest (baseline, no intervention) and when ankle plantar flexion was induced by the intervention

Secondary Outcomes (3)

• Numerical rating scale (NRS)

  Day 1 during ankle plantar flexion was induced by the intervention

• Current amplitude

  Day 1 during ankle plantar flexion was induced by the intervention

• Energy

  Day 1 during ankle plantar flexion was induced by the intervention

Study Arms (1)

Single arm where repeated measures where performed in 15 participants.

EXPERIMENTAL

Each of the 15 participants in the arm was, in addition to the resting state (no intervention), exposed to 10 different interventions repeated after each other to enable repeated measures of the outcomes.

Device: Chattanooga Physio, DJO, neuromuscular electrical stimulation

Interventions

Chattanooga Physio, DJO, neuromuscular electrical stimulation DEVICE

Neuromuscular electrical stimulation (NMES) was applied with a device called Chattanooga Physio (DJO), testing 10 different combinations of parameter-settings. The parameter-settings that were varied and combined were frequency (1Hz and 36Hz) and plateau times (0.5s, 1.5s, 3s, 5s, 7s). The NMES was applied to the calf of the participants via transversally placed textile electrodes (3x3 cm) integrated in a sock starting with very low current amplitude followed by gradual small increases in current amplitude until induction of ankle plantar flexion, at which time-point the outcomes where measured.

Also known as: Device name and manufacturer:

Single arm where repeated measures where performed in 15 participants.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-99 years of age
• Voluntary participation

You may not qualify if:

• Pregnancy
• Pacemaker
• Ongoing thromboprophylaxis
• Skin wounds
• Vascular abnormalities
• Previous vascular system surgery in the lower limbs

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Juthberg R, Flodin J, Aliaga N, Guo L, Rodriguez S, Persson NK, Ackermann PW. Electrically induced hemodynamic enhancement via sock-integrated electrodes is more comfortable and efficient at 1 hz as compared to 36 hz. Sci Rep. 2025 Apr 15;15(1):12944. doi: 10.1038/s41598-025-97431-3.

  PMID: 40234723 DERIVED

MeSH Terms

Conditions

Pain; Sedentary Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Paul Ackermann, PhD, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants did not receive information about what parameter-settings that were used for the different tests.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,MD,PhD

Model Details: Repeated measures tests on on each of the 15 participants, comparing outcomes for no intervention and 10 different interventions in the form of variations in parameter-settings of neuromuscular electrical stimulation, with gradually increasing current amplitude until induction of ankle plantar flexion.

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 13, 2023
• Study Start: July 17, 2019
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)