UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004037 |
|---|---|
| Receipt number | 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 16:01:04 |
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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
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
kein0316@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004853
