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A study on optimal exercise dose for electrical stimulation therapy in critically ill intensive care unit patients.

Optimal exercise dose of neuromuscular electrical stimulation therapy for critically ill intensive care unit patients using belt electrode skeletal muscle electrical stimulation: a single-center randomized controlled trial. - RCT of NMES in critically ill ICU patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056149
Enrollment
80
Registered
2024-11-13
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients aged 18 years and over expected to stay in ICU for more than 3 days

Interventions

Treatment (B-SES 60 min/day) starts on the day of registration (Day 1) and is administered daily from Day 1 to Day 7.It should be done for a total of 60 minutes, with interruptions along the way. Trea

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) 18 years and over. (2) Patients expected to stay in the ICU for more than 3 days

Exclusion criteria

Exclusion criteria: (1) Patients with unstable circulatory and respiratory status (2) Patients with external cardiopulmonary ventilation (3) Patients with trauma, infection, surgery, ischaemia or thrombosis of the lower limbs (4) Patients with anuria (5) Patients with implanted electronic devices (e.g. pacemakers) (6) Patients who do not wish to undergo aggressive treatment (7) Pregnant women (8) Patients with neuromuscular diseases (9) Patients on muscle relaxants (10) Patients considered unsuitable.

Design outcomes

Primary

MeasureTime frame
Percentage change in rectus femoris muscle cross-sectional area (assessed using ultrasound echocardiography on days 1 and 7 of B-SES implementation)

Secondary

MeasureTime frame
-Muscle injury (assessed using N-TITIN/urinary Cre on days 3/5/7 of B-SES start) -Adverse events during B-SES implementation -Physical function at discharge (grip strength, Medical Research Council Score, 6-minute walk distance) -ADL(Barthel Index) at discharge

Countries

Japan

Contacts

Public ContactHideyuki Oritsu

Yokohama City University Hospital Rehabilitation Department

oritsu@yokohama-cu.ac.jp0457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026