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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029353
Receipt No. R000033548
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
Date of disclosure of the study information 2017/09/29
Last modified on 2019/07/02

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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/ctr_e/ctr_view.cgi?recptno=R000033548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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