UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035195
Receipt number R000040116
Scientific Title Circuratoly responses in people with spinal cord injury during arm cranking exercise
Date of disclosure of the study information 2018/12/15
Last modified on 2018/12/10 11:49:31

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Basic information

Public title

Circuratoly responses in people with spinal cord injury during arm cranking exercise

Acronym

Circuratoly responses in people with spinal cord injury during arm cranking exercise

Scientific Title

Circuratoly responses in people with spinal cord injury during arm cranking exercise

Scientific Title:Acronym

Circuratoly responses in people with spinal cord injury during arm cranking exercise

Region

Japan


Condition

Condition

Spinal cord injury patients

Classification by specialty

Cardiology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation effect of arm cranking exercise on circuratoly responses betwwn active and inactive muscles in people with spinal cord injury

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pulmonary oxygen uptake, heart rate, muscle oxygenation, skin temperature

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

55 years-old >=

Gender

Male and Female

Key inclusion criteria

Compelte and incomplete spinal cord injury patients after 6 months injured

Key exclusion criteria

People within 6 months injured

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Horiuchi

Organization

Mt. Fuji Research Institute

Division name

Division of Human Environmental Science

Zip code


Address

Kami-yoshida 5597-1, Fuji-yoshida-city, Yamanashi

TEL

0555-72-6207

Email

mhoriuchi@mfri.pref.yamanashi.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Horiuchi

Organization

Mt. Fuji Research Institute

Division name

Division of Human Environmental Science

Zip code


Address

Kami-yoshida 5597-1, Fuji-yoshida-city, Yamanashi

TEL

0555-72-6207

Homepage URL


Email

mhoriuchi@mfri.pref.yamanashi.jp


Sponsor or person

Institute

Mt. Fuji Research Institute
Division of Human Environmental Science

Institute

Department

Personal name



Funding Source

Organization

Mt. Fuji Research Institute
Division of Human Environmental Science

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 12 Month 15 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


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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation of acridorespiratory variables duing arm-cranking exercise in people with spinal cord injury


Management information

Registered date

2018 Year 12 Month 10 Day

Last modified on

2018 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040116


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name