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Clinical study protocol for the effect of NMES and BCAA on skeletal muscles in patients after LDLT

Effects of neuromuscular electrical stimulation of quadriceps force and oral administration of branched-chain amino acid in patients after Living-donor liver transplantation: Study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071190051
Enrollment
50
Registered
2020-03-13
Start date
2020-09-09
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

decompensated cirrhosis

Interventions

Control group (A)
Participants allocated to the control group will undergo only NMES within 7 days after LDLT for 1 month in addition to their previous treatment. EMS and BCAA group (B)
Participants allocated to the NMES and BCAA group will undergo EMS within 7 days after LDLT and take BCAA-enriched snack at 100 mg/day

Sponsors

Miyaaki Hisamitsu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) an individual age; more than 20 years (2) diagnosed with decompensated liver cirrhosis (3) Performance Status (PS); 0 to 2 (4) providing written informed consent

Exclusion criteria

Exclusion criteria: (1) complicated with a bone or a joint disorder that might affect the affect the effectiveness of EMS (2) complicated with fragile skin disease that might cause skin damage due to EMS (3) complicated with cerebrovascular disorder (4) patients undergoing hemodialysis

Design outcomes

Primary

MeasureTime frame
changes in the skeletal muscle mass from baseline (day 0) to day 90 post LDLT.

Secondary

MeasureTime frame
(1) The changes in the skeletal muscle index (SMI), SMM, quadriceps strength and quadriceps muscle thickness from baseline to day 30 post LDLT. (2) changes in the SMI and quadriceps from baseline (day 0) to day 90 post LDLT. (3) The changes in the phase angle, visceral fat area, and handgrip strength from baseline to day 30 post LDLT.

Contacts

Public ContactMasafumi Haraguchi

Nagasaki University Hospital

mharaguchi@nagasaki-u.ac.jp+81-95-819-7481

Outcome results

None listed

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