UMIN-ICDS Clinical Trial

Public title

A Study of Electrical Muscle Stimulation (EMS) to Prevent Leg Muscle Loss in Patients Undergoing Lung Cancer Surgery

Acronym

Lung Cancer Surgery EMS Study

Scientific Title

Exploratory Study on the Prevention of Lower-Limb Skeletal Muscle Mass Loss Using Perioperative Electrical Muscle Stimulation (EMS) in Patients Undergoing Lung Cancer Surgery

Scientific Title:Acronym

Perioperative EMS Study in Lung Cancer Surgery

Region

Japan

Condition

Lung cancer (patients scheduled of curative resection for lobectomy, segmentectomy, or partial resection )

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To perform a perioperative EMS intervention from before surgery through hospitalization (until discharge) in patients undergoing lung cancer surgery, to evaluate its feasibility and safety, and to evaluate the change in Skeletal Muscle Mass Index (SMI) before and after surgery, particularly the change in lower-limb skeletal muscle mass, thereby exploring the effect of perioperative EMS intervention on preventing loss of skeletal muscle mass.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Change in lower-limb skeletal muscle mass index from preoperative (at admission) to postoperative day 7, measured by bioelectrical impedance analysis as the sum of left and right lower-limb skeletal muscle mass divided by height squared (kg/m2)

Key secondary outcomes

1. Change in whole-body Skeletal Muscle Mass Index (SMI change) from preoperative (at admission) to postoperative day 7, measured by bioelectrical impedance analysis (kg/m2)
2. EMS feasibility rate (proportion of planned EMS sessions actually completed from admission through postoperative day 7; defined as feasible if 80% or more of planned sessions are completed)
3. Change in grip strength from preoperative (at admission) to postoperative day 7, measured as the maximum of two measurements per hand using a digital dynamometer (kg)
4. Change in 6-Minute Walk Test distance from preoperative (at admission) to postoperative day 7, measured in accordance with American Thoracic Society/European Respiratory Society guidelines (m)
5. Incidence of postoperative complications of Clavien-Dindo classification Grade II or higher, assessed up to discharge
6. Adherence to the EMS intervention, defined as the proportion of planned sessions actually completed from admission through discharge (%)
7. Incidence and details of EMS-related adverse events occurring from admission through discharge, graded according to CTCAE v5.0
8. Exploratory comparison of the change in SMI (preoperative to postoperative day 7) between the intervention cohort and historical data from past lung cancer surgery patients at this institution who did not receive EMS

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Perioperative lower-limb EMS intervention using an electrical muscle stimulation device (SIXPAD Foot Fit 3, model SE-BZ, MTG Co., Ltd.; a contact-type device applied to the bare soles of the feet that requires no electrode attachment).
1. Preoperative intervention: From the day of admission (after obtaining consent) until the day before surgery. The built-in "Training" program (15 minutes, up to once daily) is used as the base protocol, supplemented as needed by the "Conditioning" program (12 minutes, up to twice daily). Stimulation intensity is adjusted within a 1-25 level range, according to patient tolerance, to a level causing no pain or discomfort.
2. Postoperative intervention: Starting on the day of surgery (only after at least 4 hours have elapsed since surgery and full recovery from anesthesia has been confirmed) or the day after surgery, continuing until discharge, using the same program and frequency. Intensity starts at a low level and is adjusted according to the patient's postoperative condition.
3. Site: Calf, anterior shin, and sole of the foot (the thigh is outside the scope of this device).
4. Administered by: A physician, nurse, or physical therapist.
5. As this is a single-arm study, there is no concurrent control arm; the institution's existing data (patients with no history of EMS) serve as a historical control.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients histologically or cytologically diagnosed with lung cancer, or clinically diagnosed with lung cancer
2. Patients scheduled to undergo lobectomy, segmentectomy, or partial resection
3. Patients aged 20 years or older at the time of consent
4. Patients with a Performance Status (PS) of 0-2
5. Patients able to walk preoperatively
6. Patients whose body composition can be assessed by BIA preoperatively
7. Patients who have provided written informed consent to participate in this study

Key exclusion criteria

1. Patients with an implanted cardiac pacemaker or implantable cardioverter defibrillator (ICD)
2. Patients with a prosthetic leg
3. Patients with active skin disease or a wound at the application site (sole of the foot or calf), or with a history of orthopedic surgery or implanted metal (e.g., bolts/plates) at the application site
4. Patients with an acute painful condition of the lower limb, such as fracture or osteoporosis
5. Patients with confirmed deep vein thrombosis (DVT), or judged preoperatively to be at markedly high risk of DVT
6. Patients with active infection before surgery
7. Patients with severe heart failure (NYHA class III or higher)
8. Patients currently undergoing, or within 4 weeks of completing, preoperative chemotherapy or radiotherapy for malignancy
9. Patients who are pregnant or may be pregnant
10. Patients with severe psychiatric illness that would make participation in the study difficult
11. Any other patient judged by the principal investigator to be inappropriate for participation in this study

Target sample size

20

Name of lead principal investigator

1st name	Ryota
Middle name
Last name	Nakamura

Organization

National Hospital Organization Mito Medical Center

Division name

Department of Surgery

Zip code

311-3193

Address

280 Sakuranosato, Ibaraki-machi, Higashiibaraki-gun, Ibaraki, Japan

TEL

0292407711

Email

ryo.naka820@gmail.com

Name of contact person

1st name	Ryota
Middle name
Last name	Nakamura

Organization

National Hospital Organization Mito Medical Center

Division name

Department of Surgery

Zip code

310-0911

Address

280 Sakuranosato, Ibaraki-machi, Higashiibaraki-gun, Ibaraki, Japan

TEL

0292407711

Homepage URL

Email

ryo.naka820@gmail.com

Institute

National Hospital Organization Mito Medical Center

Institute

Department

Personal name

Ryota Nakamura

Organization

National Hospital Organization Mito Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

National Hospital Organization Mito Medical Center

Address

280 Sakuranosato, Ibaraki-machi, Higashiibaraki-gun, Ibarak, Japan

Tel

+81-29-240-7711

Email

ryo.naka820@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

15

Day

Date of IRB

2026

Year

07

Month

15

Day

Anticipated trial start date

2026

Year

09

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

27

Day

Last modified on

2026

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071350

Single case data URL

Value
https://center6.umin.ac.jp/ice/71350