UMIN-CTR Clinical Trial

Public title

Open single-group comparative study on oxygen uptake during walking training Simultaneously Combined with Neuromuscular Electrical Stimulation (NMES) of Antagonists for adult male

Acronym

Open single-group comparative study on oxygen uptake during walking training Simultaneously Combined with Neuromuscular Electrical Stimulation (NMES) of Antagonists for adult male

Scientific Title

Open single-group comparative study on oxygen uptake during walking training Simultaneously Combined with Neuromuscular Electrical Stimulation (NMES) of Antagonists for adult male

Scientific Title:Acronym

Open single-group comparative study on oxygen uptake during walking training Simultaneously Combined with Neuromuscular Electrical Stimulation (NMES) of Antagonists for adult male

Region

Japan

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A Hybrid Training System (HTS) that creates resistance to the motion of a voluntarily contracting agonist muscle by means of the force generated by its electrically stimulated antagonist has been developed. In collaboration with Panasonic Corporation in 2014, we developed a "hiza trainer" which is an HTS device that can be conveniently used by elderly people. Treadmill walking training with and without a hiza trainer are performed for adult male. Oxygen uptake during walking training are compared.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Expired gas is measured at resting bedding and at walking training at 4 km/h and 5.6 km/h with and without a hiza trainer. The average value of oxygen intake in each section is taken. The value in the case of wearing the hiza trainer and the value in the case of not wearing the hiza trainer are compared in each section.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

All participants are measured for height and body weight, and performed two walking training tests.
Participants are measured for gas exchange during walking training according to the following protocol.
First protocol:
They are rested bed for 5 minutes, and walk at 4 km/h for 5 minutes, walk at 5.6 km/h for 5 minutes. In each section, expired gas is measured.
Second Protocol:
They wear hiza trainers. They are rested bed for 5 minutes, and walk at 4 km/h for 5 minutes, walk at 5.6 km/h for 5 minutes. In each section, expired gas is measured.

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

65

years-old

>=

Gender

Male

Key inclusion criteria

For those who meet all of the following criteria
1) Male over 20 years old
2) Persons who got consent on this exam

Key exclusion criteria

Those who fall under any of the following exclusion criteria are excluded from the target
1) Impossible to use household low frequency treatment equipment
2) People who can not walk on their own will be.
3) Hospitalized person
4) For people with acute illness
5) Those with malignant tumors
6) Infectious disease people
7) Persons with severe heart, kidney and liver problems
8) Those with a body temperature of 38 degrees Celsius or higher (thermophilic term)
(e.g. when there is a strong period of acute inflammatory symptoms (fatigue, chill, blood pressure fluctuation etc), weakness)
9) Anemia with clinical symptoms
10) High blood pressure and diabetes who can not control treatment
11) One with some abnormality (infection, wound etc.) in the thigh skin
12) Persons who have acute (painful) disorders such as fractures, sprains, muscles of the spine
13) Advanced peripheral circulation disorder due to diabetes etc. or peripheral nerve disorder
14) Those who feel abnormality in the body other than the above
15) Persons with limb paralysis
16) Persons wearing implantable medical electronic devices such as pacemakers
17) Persons using life-saving medical electronic equipment such as artificial heart-lung
18) Wearing a wearable medical electronic device such as an electrocardiograph
19) Venous and arterial thrombus
20) Persons who are prohibited from exercising by a doctor
21) Persons who can not walk independently
22) For people with analgesia
23) If you can not display (operate) yourself
24) Person undergoing treatment with consciousness disorder, dementia, etc. or those who need treatment
25) People with sensitive skin or those with allergies to gels
26) Those who put bolts in the body
27) Epilepsy person
28) Others who judged that the examination responsible doctor or shared medical doctor is ineligible as a target
29) Those who had prescription changes for diabetes medication within 3 months

Target sample size

18

Name of lead principal investigator

1st name	Hiroo
Middle name
Last name	Matsuse

Organization

Department of Orthopedics, Kurume University School of Medicine

Division name

Division of Rehabilitation

Zip code

830-0011

Address

67 asahi-machi, Kurume Fukuoka

TEL

0942-31-7568

Email

matsuse_hiroh@kurume-u.ac.jp

Name of contact person

1st name	Masafumi
Middle name
Last name	Bekki

Organization

Department of Orthopedics, Kurume University School of Medicine

Division name

Division of Rehabilitation

Zip code

830-0011

Address

67 asahi-machi, Kurume Fukuoka

TEL

0942-31-7568

Homepage URL

Email

bekki_masafumi@med.kurume-u.ac.jp

Institute

Kurume University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Orthopedics, Kurume University School of Medicine

Address

67 asahi-machi, Kurume Fukuoka

Tel

0942-31-7568

Email

bekki_masafumi@med.kurume-u.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

Date of disclosure of the study information

2017

Year

09

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

15

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

Completed

Date of protocol fixation

2017

Year

07

Month

01

Day

Date of IRB

2017

Year

05

Month

26

Day

Anticipated trial start date

2017

Year

09

Month

13

Day

Last follow-up date

2017

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

29

Day

Last modified on

2019

Year

07

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033548