UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024279 |
|---|---|
| Receipt number | R000027972 |
| Scientific Title | The influence of atrophy and fatty degeneration of suprahyoid muscles on swallowing function: a preliminary MRI study. |
| Date of disclosure of the study information | 2016/10/04 |
| Last modified on | 2016/10/04 12:16:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The influence of atrophy and fatty degeneration of suprahyoid muscles on swallowing function: a preliminary MRI study.
Acronym
Sarcopenic Dysphagia
Scientific Title
The influence of atrophy and fatty degeneration of suprahyoid muscles on swallowing function: a preliminary MRI study.
Scientific Title:Acronym
Sarcopenic Dysphagia
Region
| Japan |
Condition
Condition
Patients with sarcopenia and dysphaia
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate of the influence of atrophy and fatty degeneration of suprahyoid muscles atrophy on swallowing function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass/fat, muscle power, swallowing function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who have evaluated swallowing ability in department of rehabilitation, Hyogo college of medicine.
(2)Patients who can walk.
(3)Patients who agreed to participate in this study.
Key exclusion criteria
(1)Patients who have history of stroke.
(2)Patients who have the pacemaker or artificial joint.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798-45-6644
office@craseed.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Nakao |
Organization
Hospital of Hyogo College of Medicine
Division name
Department of physical medicine and rehabilitation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798-45-6345
Homepage URL
ynakao33@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 04 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to investigate of the influence of atrophy and fatty degeneration of suprahyoid muscles atrophy on swallowing function.
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2016 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027972
