UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047252 |
|---|---|
| Receipt number | R000053894 |
| Scientific Title | Analysis of physiological changes by an exercise strengthening respiratory function |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/03/22 19:25:10 |
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Basic information
Public title
Analysis of physiological changes by
an exercise strengthening respiratory function
Acronym
Physiological effects by strengthening respiratory function
Scientific Title
Analysis of physiological changes by
an exercise strengthening respiratory function
Scientific Title:Acronym
Physiological effects by strengthening respiratory function
Region
| Japan |
Condition
Condition
lifestyle-related illness, aging
Classification by specialty
| Medicine in general | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is possible to decrease respiratory function by improper lifestyle or aging due to degeneration of respiratory muscles. We analyze whether exercise strengthening respiratory functions might associate with increase of mitochondria numbers and brain function in persons who have respiratory function lower than standards.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of respiratory function by spirometer 3 weeks after beginning of the exercise.
Key secondary outcomes
Analysis of brain function by Uchida/Klepeline test
Determination of semi-values of salivary mitochondria by real-time PCR
Determination of serotonin in serum
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two times of five minutes exercise strengthening respiratory function everyday for three weeks/no exercise
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 and Female
Key inclusion criteria
persons who have respiratory functions lower than the functions of standards of the same age.
Key exclusion criteria
persons who were diagnosed to have respiratory disease by medical doctors
persons who can not carried out the performance of the exercise
persons for whom the exercise is improper by suggestion of medical doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sanju |
| Middle name | |
| Last name | Iwamoto |
Organization
Showa University School of Pharmacy
Division name
Physiology & Pathology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
0337848040
iwasanju@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Sanju |
| Middle name | |
| Last name | Iwamoto |
Organization
Showa University School of Pharmacy
Division name
Physiology & Pathology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
0337848040
Homepage URL
iwasanju@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
0337848040
iwasanju@med.showa-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
| 2022 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053894
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
