UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053979 |
|---|---|
| Receipt number | R000061616 |
| Scientific Title | Rehabilitative intervention of frailty for patients with chronic respiratory disease |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/04/22 12:07:07 |
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Basic information
Public title
Rehabilitative intervention of frailty for patients with chronic respiratory disease
Acronym
Rehabilitative intervention for patients with chronic respiratory disease
Scientific Title
Rehabilitative intervention of frailty for patients with chronic respiratory disease
Scientific Title:Acronym
Rehabilitative intervention for patients with chronic respiratory disease
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Medicine in general | Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the novel rehabilitation program based on the items in the Short Physical Performance Battery (SPPB) for older patients with chronic respiratory diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The novel rehabilitation program based on the items in the Short Physical Performance Battery (SPPB)
Interventions/Control_2
No intervention
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
Clinically stable patients with no changes in the medication schedule or dosage for at least 4 weeks before enrollment
Key exclusion criteria
1. severe orthopedic or neurological disorders
2. unstable cardiac disease
3. weak skin
4. malignancy
5. pregnant
6. inability to complete questionnaires
Target sample size
184
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hanada |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197258
mstshnd@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hanada |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197258
Homepage URL
mstshnd@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Masatoshi Hanada
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7905
gaibushikin@ml.nagasaki-u.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 | 01 | 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 | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061616
