UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048761 |
|---|---|
| Receipt number | R000055555 |
| Scientific Title | Feasibility of rehabilitation interventions based on Short Physical Performance Battery for frailty patients with chronic respiratory diseases |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2024/04/22 12:12:33 |
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Basic information
Public title
Feasibility of rehabilitation interventions based on Short Physical Performance Battery for frailty patients with chronic respiratory diseases
Acronym
Feasibility of rehabilitation interventions based on Short Physical Performance Battery for frailty patients with chronic respiratory diseases
Scientific Title
Feasibility of rehabilitation interventions based on Short Physical Performance Battery for frailty patients with chronic respiratory diseases
Scientific Title:Acronym
Feasibility of rehabilitation interventions based on Short Physical Performance Battery for frailty patients with chronic respiratory diseases
Region
| Japan |
Condition
Condition
Interstitial lung diseases
Classification by specialty
| Medicine in general | Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a novel rehabilitation intervention for patients with CRD who has frailty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity (the number of steps)
Key secondary 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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitation programs based on SPPB items
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Under the care of a respiratory physician, were able to walk, and clinically stable without changes in medications for at least 4 weeks before enrollment.
Key exclusion criteria
comorbid conditions affecting exercise performance (e.g., musculoskeletal or neurological disorders), severe cognitive impairment, pregnancy, recent thoracic surgery, and active cancer treatment.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name
Department of Physical therapy Science
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197963
ryokozu@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, Japan
TEL
0958197258
Homepage URL
mstshnd@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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 Human Ethics Review Committee of the Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197229
Not applicable
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
| 2022 | Year | 08 | Month | 25 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 08 | Month | 25 | 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=R000055555
