UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052865 |
|---|---|
| Receipt number | R000060328 |
| Scientific Title | Investigation of upper extremity dysfunction and quantification of posture in patients of COPD: Assessing with musculoskeletal disorders perspectives |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2025/01/22 10:33:14 |
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Basic information
Public title
Investigation of upper extremity dysfunction and quantification of posture in patients of COPD: Assessing with musculoskeletal disorders perspectives
Acronym
Investigation of upper extremity dysfunction and quantification of posture in patients of COPD: Assessing with musculoskeletal disorders perspectives
Scientific Title
Investigation of upper extremity dysfunction and quantification of posture in patients of COPD: Assessing with musculoskeletal disorders perspectives
Scientific Title:Acronym
Investigation of upper extremity dysfunction and quantification of posture in patients of COPD: Assessing with musculoskeletal disorders perspectives
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Relationship between upper limb dysfunction and physical function in COPD patients
2. Objectification of poor posture and quantification of barrel chest
3. Relationship between poor posture and severity of COPD
Basic objectives2
Others
Basic objectives -Others
Analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chest width/thickness, chest/waist circumference, angle of clavicle elevation, angle of scapula upward rotation/forward tilt, scapula abduction distance, spinal curvature, muscle tightness, upper limb function (range of motion, muscle strength), nerve/vascular impairment test, spirometory, MRC dyspnea scale, Quick DASH, HAND 10, The Nagasaki University Respiratory ADL questionnaire (NRADL)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Phase 1
A male employee of the rehabilitation department of Jobu Hospital.
Phase 2
Male patients with COPD who are regular outpatients at Jobu Hospital.
each phase
Smoking history and pulmonary function measurements will not be asked.
Patients who can give written consent to participate in this study.
Key exclusion criteria
Women.
Patients with disabilities that prevent them from writing or with dementia.
Patients who have been diagnosed with a disease that causes deformity or dysfunction of the spine (cervical spine, thoracic spine, lumbar spine), shoulder girdle, upper limbs, or rib cage, or who have a history of injury or surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma university, Graduateschool of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, GUnma, JAPAN
TEL
027-220-8971
dkato@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma university, Graduateschool of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, GUnma, JAPAN
TEL
027-220-8971
Homepage URL
dkato@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Daigo Kato
Funding Source
Organization
The 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
Institutional review board of Jobu hospital for respiratory diseases
Address
586-1, Taguchi, Maebashi, Gunma, JAPAN
Tel
027-232-5000
ichiyokai-jkn@mvd.biglobe.ne.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
| 2023 | Year | 11 | Month | 21 | 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
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case series study
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060328
