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

JRCT ID: jRCTs071190051

Registered date:13/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: decompensated cirrhosis
• Date of first enrollment: 09/09/2020
• Target sample size: 50
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: changes in the skeletal muscle mass from baseline (day 0) to day 90 post LDLT.

Secondary Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyaaki Hisamitsu