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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004037
Receipt No. R000004853
Scientific Title Renal function and endocrine responses during exercise in persons with spinal cord injuries.
Date of disclosure of the study information 2010/08/12
Last modified on 2015/02/13

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Basic information
Public title Renal function and endocrine responses during exercise in persons with spinal cord injuries.
Acronym Renal function and endocrine responses during exercise in persons with spinal cord injuries.
Scientific Title Renal function and endocrine responses during exercise in persons with spinal cord injuries.
Scientific Title:Acronym Renal function and endocrine responses during exercise in persons with spinal cord injuries.
Region
Japan

Condition
Condition spinal cord injuries
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary purpose of this study was to investigate the renal and endocrine responses to moderate intensity of exercise in SCI, and to examine the characteristics of SCI compared to AB subjects.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Urine and venous blood samples were collected at 5 points (before exercise, 60min of exercise, immediately after exercise, 1h following completion of exercise and 2h following completion of exercise). We measured plasma adrenaline, noradrenaline, dopamine, plasma renin activity (PRA), plasma aldosterone (Pald), human atrial natriuretic polypeptide (hANP), creatinine, Hb, hematocrit, plasma osmolality, Na, plasma antidiuretic hormone (ADH), urine creatinine, osmolality and Na
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 5 h rest examination as a time control study in spinal cord injury subjects and able body subjects
Interventions/Control_2 resting on chairs for 1 hour, exerciseing on an arm crank ergometer for 2 h at intensities of 60% VO2max and 2 h recovery period in resting condition on chairs after completion of 2 h exercise in spinal cord injury subjects and able body subjects.
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
50 years-old >=
Gender Male
Key inclusion criteria persons with spinal cord injury and able-bodied persons
Key exclusion criteria persons who fall ill with cardiovascular, pulmonary and renal diseases or have a personal history of cardiovascular, pulmonary and renal diseases
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiro Tajima
Organization Wakayama Medical University
Division name Department of Rehabilitation Medicine
Zip code
Address 811-1 Kimiidera,wakayama-shi,wakayama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kawasaki
Organization Wakayama Medical University
Division name Department of Rehabilitation Medicine
Zip code
Address
TEL
Homepage URL
Email kein0316@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation Medicine, Wakayama Medical 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
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 和歌山県立医科大学病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2010 Year 12 Month 29 Day
Date analysis concluded
2011 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 12 Day
Last modified on
2015 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004853

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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