UMIN-CTR Clinical Trial
| 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 (Ver. 6) |
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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 | |
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| Condition | ||||
| Condition | Healthy adults | |||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | healthy volunteers |
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| Participant flow | The participants were recruited from a university. |
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| Adverse events | Non |
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| 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). |
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| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Date trial data considered complete | |||||||
| Date analysis concluded |
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| Other | |
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| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034246 |
