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An exploratory randomized controlled trial testing efficacy of adjunctive electrical muscle stimulation used in early rehabilitation in patients with sepsis

An exploratory randomized controlled trial testing efficacy of adjunctive electrical muscle stimulation used in early rehabilitation in patients with sepsis - Sepsis EMS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033540
Enrollment
70
Registered
2018-07-27
Start date
2018-09-01
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

Sepsis

Interventions

The intervention group will receive EMS as follows. Belt electrodes of the Auto Tens Pro (Homer Ion Co. Ltd., Tokyo, Japan) will be placed around the abdomen, distal part of both thighs, and both ankl

Sponsors

Center Hospital of the National Center for Global Health and Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.A signed informed consent form for participation in the study provided by the patient, or if difficult, by an authorized representative who has the legal capacity to decide the therapy strategy. 2.=> 20 years old 3.Diagnosis of sepsis

Exclusion criteria

Exclusion criteria: 1.Presence of a pacemaker 2.Known primary systemic neuromuscular disease or intracranial disease at admission 3.Pre-hospitalization functional independence measure (FIM) score < 80, with inability to walk independently 4.Fracture or skin lesion (except contusion) in the region subjected to EMS (thigh, knee joint, ankle joint) 5.Pregnancy 6.Assessed as approaching or imminent death 7.Trauma 8.Unable to reach consensus 9.Determined by the physician-in-charge

Design outcomes

Primary

MeasureTime frame
The primary outcome is decrement in quadriceps strength (N/kg) on Day 15 versus Day 1.

Secondary

MeasureTime frame
Secondary outcomes are decrements in muscle strength grade determined by the manual muscle test (MMT) and in thickness of the rectus femoris muscle on Day 1, Day 8, and Day 15. The pre-hospitalization FIM score will be recorded on the day of hospital admission, and change in the FIM score on Day 15 compared with the prehospitalization value will be assessed

Countries

Japan

Contacts

Public ContactKento Takii

Center Hospital of the National Center for Global Health and Medicine Department of Emergency Medicine and Critical Care

ktakii@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

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