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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029986
Receipt No. R000034246
Scientific Title Effect of training of trunk muscle on tongue pressure and pulmonary function
Date of disclosure of the study information 2017/11/15
Last modified on 2020/05/18

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Basic information
Public title Effect of training of trunk muscle on tongue pressure and pulmonary function
Acronym Effect of training of trunk muscle on tongue pressure and pulmonary function
Scientific Title Effect of training of trunk muscle on tongue pressure and pulmonary function
Scientific Title:Acronym Effect of training of trunk muscle on tongue pressure and pulmonary function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Pneumology Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of Training
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tongue pressure, Vaital Capacity, FEV1.0
Key secondary outcomes

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 Treatment
Type of intervention
Other
Interventions/Control_1 Trunk training
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
18 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria University Students
Key exclusion criteria disagreements
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Ishizaka
Organization Inernational University of Health and Walfare
Division name Department of Physical Therapy
Zip code 329-8501
Address 2600-1 Kitakanemaru Ohtawara city Tochigi pref
TEL 0287-24-3018
Email ishizaka@iuhw.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Ishizaka
Organization Inernational University of Health and Walfare
Division name Department of Physical Therapy
Zip code 329-8501
Address 2600-1 Kitakanemaru Ohtawara city Tochigi pref
TEL 0287-24-3018
Homepage URL
Email ishizaka@iuhw.ac.jp

Sponsor
Institute Inernational University of Health and Walfare
Institute
Department

Funding Source
Organization Inernational University of Health and Walfare
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 Inernational University of Health and Walfare
Address 2600-1 Kitakanemaru Ohtawara city Tochigi pref
Tel 0287-24-3000
Email ishizaka@iuhw.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
2017 Year 11 Month 15 Day

Related information
URL releasing protocol https://rehaac.org/asia_meeting.html
Publication of results Unpublished

Result
URL related to results and publications https://rehaac.org/asia_meeting.html
Number of participants that the trial has enrolled 12
Results
Training significantly impacted the skeletal muscle mass of the right and left arm, MPT, MVV and PEmax.
Results date posted
2020 Year 05 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteers 
Participant flow
The participants were recruited from a university. 
Adverse events
Non
Outcome measures
Subjects muscle mass was measured using Inbody.  Data collected  were grip strength (GS), calf circumstance (CC), finger floor distance (FFD), maximum phonation time (MPT), vital capacity (VC), forced vital capacity (FVC), forced expiratory volume 1.0 (FEV1.0), maximal voluntary ventilation (MVV), maximal expiratory pressure(PEmax), maximal inspiratory pressure (PImax), and tongue pressure (TP).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 11 Month 08 Day
Anticipated trial start date
2017 Year 11 Month 15 Day
Last follow-up date
2017 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034246

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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