UMIN-ICDS Clinical Trial

Public title

A study of arm muscle activity when using an arm-curl assistive device that assists the lifting motion with air pressure

Acronym

A study of muscle activity during the use of an arm-curl assistive device

Scientific Title

Evaluation of muscle activity during use of a pneumatically assisted arm-curl device specialized for eccentric exercise

Scientific Title:Acronym

Muscle activity evaluation of a pneumatically assisted arm-curl device

Region

Japan

Condition

Resistance training in healthy adults (no disease condition)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify how a pneumatically assisted arm-curl device, which assists the lifting (concentric) phase with a pneumatic cylinder so that a high load can be applied in the lowering (eccentric) phase, changes muscle activity in the eccentric phase, by measuring surface electromyography of the elbow flexors during arm-curl exercise with the device and comparing it with conventional arm-curl exercise.

Basic objectives2

Others

Basic objectives -Others

Evaluation of muscle activity during device use (evaluation of the mechanical characteristics of the device)

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Surface EMG amplitude (root mean square, normalized to maximal voluntary contraction) of the elbow flexors during arm-curl exercise (10 repetitions x 1 set) in each condition, analyzed separately for the eccentric and concentric phases. Assessed during exercise in each condition (single session, same day).

Key secondary outcomes

Integrated EMG and mean frequency in each condition and phase; rating of perceived exertion (Borg scale) after each condition.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Each participant performs all three arm-curl conditions in a single session (approximately 60 min) on the same day: (1) conventional arm-curl exercise without the device; (2) arm-curl exercise using the device with the pneumatic assist switched off; (3) arm-curl exercise using the device with the pneumatic assist switched on during the lifting phase. In each condition, participants perform 10 repetitions x 1 set at a load they can comfortably repeat 10 times (common to all three conditions), with at least 5 minutes of rest between conditions. The order of conditions is counterbalanced across participants. The device is used only once, on the day of measurement; there is no repeated or continuous intervention.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults aged 18 years or older with no history of orthopedic disease of the upper limb (shoulder, elbow, wrist) and no current pain or skin problems in the upper limb.

Key exclusion criteria

Persons whose physical activity is restricted by a physician; persons with a history of skin problems caused by electrodes or tape; persons who performed high-intensity upper-limb training within 48 hours before the measurement.

Target sample size

15

Name of lead principal investigator

1st name	Keisuke
Middle name
Last name	Naniwa

Organization

Hokkaido University of Science

Division name

Department of Mechanical Engineering, Faculty of Engineering

Zip code

0068585

Address

7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido, Japan

TEL

0116882283

Email

naniwa-k@hus.ac.jp

Name of contact person

1st name	Keisuke
Middle name
Last name	Naniwa

Organization

Hokkaido University of Science

Division name

Department of Mechanical Engineering, Faculty of Engineering

Zip code

0068585

Address

7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido, Japan

TEL

0116882283

Homepage URL

Email

naniwa-k@hus.ac.jp

Institute

Hokkaido University of Science

Institute

Department

Personal name

Keisuke Naniwa

Organization

Hokkaido University of Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Pharmaceutical Sciences Ethics Committee, Hokkaido University of Science

Address

7-15-4-1 Maeda, Teine-ku, Sapporo, Hokkaido 006-8585, Japan

Tel

011-688-2241

Email

kenkyu@hus.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道科学大学（北海道）

Date of disclosure of the study information

2026

Year

11

Month

09

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

11

Month

06

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2028

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

11

Month

09

Day

Last modified on

2026

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072747