UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057088 |
|---|---|
| Receipt number | R000063570 |
| Scientific Title | Effectiveness of Educational Hospitalization for Patients with Interstitial Pneumonia |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/20 07:43:43 |
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Basic information
Public title
Effectiveness of Educational Hospitalization for Patients with Interstitial Pneumonia
Acronym
Effectiveness of Educational Hospitalization for Patients with Interstitial Pneumonia
Scientific Title
Effectiveness of Educational Hospitalization for Patients with Interstitial Pneumonia
Scientific Title:Acronym
Effectiveness of Educational Hospitalization for Patients with Interstitial Pneumonia
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of rehabilitation training on body composition, physical function, and quality of life through rehabilitation training provided to ILD patients during their educational hospitalization, and to study the effects of rehabilitation training intervention for ILD patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Collect scores on the Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire and the Living with Pulmonary Fibrosis (L-PF) Quality of Life on the day of educational admission and discharge and at 2 weeks, 1 month, 3 months and 6 months after discharge Symptoms Questionnaire.
Key secondary outcomes
As exercise function, the 6-minute walk test, open/close stepping test, and 30-second chair rise test Hand-held Dynamometer (HHD) will be used to evaluate quadriceps muscle strength. In addition, body composition will be evaluated using InBody, and exercise continuation will be assessed using daily step count data. Dyspnea levels will be evaluated using the
Modified MRC Shortness of Breath Scale, Hugh-Jones classification, K-BILD to assess health status, basic patient information including age, gender, height, weight, concurrent illnesses, current medical history, treatment history, survival status, type of ILD, chest x-ray, chest CT, and respiratory function tests will be collected as imaging information.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with interstitial pneumonia who are eligible for interstitial pneumonia educational admission at this hospital
Key exclusion criteria
1)Patients with a history of cerebrovascular disease
2)Patients who have refused to participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Takamori |
Organization
Dokkyo Medical University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282861111
takamori@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Takamori |
Organization
Dokkyo Medical University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282861111
Homepage URL
takamori@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Masayoshi Takamori
Funding Source
Organization
Dokkyo Medical 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
Clinical Research Review Board, Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
0282861111
r-kenkyu@dokkyomed.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
獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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
| 2024 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study was designed to compare the effectiveness of educational hospitalization at our hospital by extracting case data from medical records in a retrospective manner.
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063570
