UMIN-CTR Clinical Trial

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
Email	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
Email	iwasanju@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053894