UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044643 |
|---|---|
| Receipt number | R000050372 |
| Scientific Title | Relationship between ADL and cough strength (maximum expiratory flow rate) in patients admitted to a recovery ward |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2022/01/24 13:36:24 |
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Basic information
Public title
Relationship between ADL and cough strength (maximum expiratory flow rate) in patients admitted to a recovery ward
Acronym
Relationship between ADL and cough force (maximum expiratory flow rate)
Scientific Title
Relationship between ADL and cough strength (maximum expiratory flow rate) in patients admitted to a recovery ward
Scientific Title:Acronym
Relationship between ADL and cough force (maximum expiratory flow rate)
Region
| Japan |
Condition
Condition
Any disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between ADL and coughing ability in patients admitted to a recovery ward.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate the relationship between ADL and coughing ability in patients admitted to a recovery ward. ADL is evaluated by measuring the commonly used FIM.
If the relationship between ADL and coughing ability can be suggested, the risk of aspiration pneumonia can be predicted from the FIM score, and prevention or associated rehabilitation can be expected to reduce hospital stays and improve daily life.
Translated with www.DeepL.com/Translator (free version)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional independence measure
Key secondary outcomes
maximum expiratory flow rate
Per-ventilation volume
Spirometry
Effort lung capacity
momentary amount
rate per second
Muscle thickness of the lateral abdominal muscles
body weight
Body fat percentage
Skeletal muscle ratio
Visceral Fat Level
Subcutaneous fat rate
Basal metabolism
Body mass index
thoracic dilation difference
Hasegawa dementia rating scale-revised
bedridden level
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Respiratory function test, abdominal echo
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons with a bedridden status of rank A, B, or C
Key exclusion criteria
Patients with serious respiratory diseases, skin abnormalities, pacemakers, severe aphasia, dementia (HDS-R score of 20 or below)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kikuko |
| Middle name | |
| Last name | Ikeda |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Department of Rehabilitation
Zip code
274-8503
Address
2-11-1 Takanedai,Funabashi-shi,Chiba Japan
TEL
0474667111
reha2012pta20@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Sato |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Department of Rehabilitation
Zip code
274-8503
Address
2-11-1 Takanedai,Funabashi-shi,Chiba Japan
TEL
0474667111
Homepage URL
reha2012pta20@yahoo.co.jp
Sponsor or person
Institute
CHIBA TOKUSHUKAI HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
CHIBA TOKUSHUKAI HOSPITAL
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
Joint Ethics Review Committee
Address
Emina Building 3F, 1-8-7 Kojimachi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ecl@mirai-iryo.com
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
| 2021 | Year | 06 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050372
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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