UMIN-CTR Clinical Trial

Basic information
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
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date	2017 Year 09 Month 29 Day
Last modified on	2019 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033548