UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030547 |
|---|---|
| Receipt number | R000034747 |
| Scientific Title | Multivariate analysis of coughing ability using functional evaluation for hospitalized patients. |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/06/26 22:07:01 |
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Basic information
Public title
Multivariate analysis of coughing ability using functional evaluation for hospitalized patients.
Acronym
Examination of sputum production ability using functional evaluation.
Scientific Title
Multivariate analysis of coughing ability using functional evaluation for hospitalized patients.
Scientific Title:Acronym
Examination of sputum production ability using functional evaluation.
Region
| Japan |
Condition
Condition
hospitalized patient
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the relationship between the respiratory function that the therapist can measure by hand or the like and the cough peak flow, it aims to find indicators that can easily grasp factors of coughing power even in clinical treatment.
Basic objectives2
Others
Basic objectives -Others
Causal relationship
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cough peak flow
(Measured on the same day as key secondary outcomes)
Key secondary outcomes
Vital capacity, percent vital capacity, thorax extension difference, maximum phonation time, abdominal uplift force, trunk flexor muscle strength, age, height, body weight, body mass index,
Functional Independence Measure.
(Measurement and calculation on the same day as the primary 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
| Maneuver |
Interventions/Control_1
Intervene once during discharging.
Cough peak flow is measured three times.
Vital capacity is measured twice.
Thorax extension difference is measured once.
maximum phonation time is measured twice.
abdominal uplift force is measured twice.
trunk flexor muscle strength is measured twice.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hospitalized patient.
Rehabilitation is prescribed.
Adequate understanding and consent are obtained for the evaluation and research objectives.
Sitting retention is monitored or independent.
Key exclusion criteria
Patients with poor subjective symptoms such as breathing difficulty and pain.
Patient who can not make effortive cough.
Patient who can not follow the indicated action due to consciousness disturbance, mental disorder, dementia, etc.
Tracheal intubation, tracheostomy patients or patients undergoing thoracoabdominal surgery.
A patient suffering from an infectious disease such as MRSA.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwai Nobuhiko |
Organization
KOBE GAKUIN UNIVERSITY
Division name
Faculty of Rehabilitation
Zip code
Address
Kobe City, Hyogo Prefecture, Nishi-ku, Ikawadani MachiArase 518
TEL
078-974-1551
iwai@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwai Nobuhiko |
Organization
KOBE GAKUIN UNIVERSITY
Division name
Faculty of Rehabilitation
Zip code
Address
Kobe City, Hyogo Prefecture, Nishi-ku, Ikawadani MachiArase 518
TEL
078-974-1551
Homepage URL
iwai@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Social medical corporation,
Saneikai,Tsukazaki hospital.
Institute
Department
Personal name
Funding Source
Organization
KOBE GAKUIN UNIVERSITY
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
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
| 2018 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034747
