UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029986 |
|---|---|
| Receipt number | 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 11:15:13 |
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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
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
ishizaka@iuhw.ac.jp
Sponsor or person
Institute
Inernational University of Health and Walfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034246
| Research Plan | |
|---|---|
| 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 |
