UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054702 |
|---|---|
| Receipt number | R000061071 |
| Scientific Title | Study on Appropriate Loading of Abdominal Pad for Patients with Chronic Obstructive Pulmonary Disease Using ultrasonography |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2024/06/19 10:43:19 |
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Basic information
Public title
Study on Appropriate Loading of Abdominal Pad for Patients with Chronic Obstructive Pulmonary Disease Using ultrasonography
Acronym
Study on Appropriate Loading of Abdominal Pad for Patients with Chronic Obstructive Pulmonary Disease Using ultrasonography
Scientific Title
Study on Appropriate Loading of Abdominal Pad for Patients with Chronic Obstructive Pulmonary Disease Using ultrasonography
Scientific Title:Acronym
Study on Appropriate Loading of Abdominal Pad for Patients with Chronic Obstructive Pulmonary Disease Using ultrasonography
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease, Adult
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether ultrasound images can be used to determine the appropriate load for the abdominal pad, a part of respiratory rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diaphragm thickness
Key secondary outcomes
vital capacity, inspiratory capacity, forced expiratory volume in one second, maximal inspiratory pressure,
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform abdominal breathing without setting the load
Interventions/Control_2
Perform abdominal breathing with a load that maximizes diaphragm thickness on ultrasonograpy
Interventions/Control_3
Perform abdominal breathing with a load 1.0 kg lighter than the load at which the diaphragm thickness was maximal on ultrasonography
Interventions/Control_4
Perform abdominal breathing with a load 1.0 kg heavier than the load that maximized diaphragm thickness on ultrasonography
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
Patients with chronic obstructive pulmonary disease or healthy adults
Pilot study included healthy adults
Key exclusion criteria
Inability to perform respiratory function tests and inspiratory muscle training
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | masakazu |
| Middle name | |
| Last name | murakami |
Organization
japan healthcare university
Division name
Faculty of Health Sciences, Department of Rehabilitation, Division of Occupational therapy
Zip code
062-0053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
TEL
011-351-6100
mskz-murakami@jhu.ac.jp
Public contact
Name of contact person
| 1st name | masakazu |
| Middle name | |
| Last name | murakami |
Organization
japan healthcare university
Division name
Faculty of Health Sciences, Department of Rehabilitation, Division of Occupational therapy
Zip code
062-0053
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
TEL
011-351-6100
Homepage URL
mskz-murakami@jhu.ac.jp
Sponsor or person
Institute
japan healthcare univercity
Institute
Department
Personal name
Funding Source
Organization
japan healthcare univercity
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
japan healthcare university
Address
1-50, Tsukisamu Higashi 3-jo 11-chome, Toyohira-ku, Sapporo
Tel
0113516100
mskz-murakami@jhu.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
| 2024 | Year | 06 | Month | 30 | 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
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A preliminary study targeting healthy university students with no history of respiratory disease has been completed, and we are now at the stage of conducting research targeting elderly people and those with underlying diseases.
Management information
Registered date
| 2024 | Year | 06 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061071
