UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053764 |
|---|---|
| Receipt number | R000061296 |
| Scientific Title | Phase angle as an indicator of sarcopenia and malnutrition in patients with COPD |
| Date of disclosure of the study information | 2024/03/03 |
| Last modified on | 2025/03/27 22:35:28 |
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Basic information
Public title
Phase angle as an indicator of sarcopenia and malnutrition in patients with COPD
Acronym
Phase angle as an indicator of sarcopenia and malnutrition in COPD
Scientific Title
Phase angle as an indicator of sarcopenia and malnutrition in patients with COPD
Scientific Title:Acronym
Phase angle as an indicator of sarcopenia and malnutrition in COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between phase angle and sarcopenia and malnutrition in patients with COPD and to determine the cutoff values for phase angle in the presence of sarcopenia and malnutrition, respectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle
Key secondary outcomes
Sarcopenia
Malnutrition
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants are patients with COPD and controls served as control participants who are in a stable state and regularly followed-up at the outpatient department of respiratory medicine, Tohoku Medical and Pharmaceutical University Wakabayashi Hospital.
Key exclusion criteria
(1) Had an exacerbation within the past month at the time of periodic evaluation, (2) contraindications to BIA due to a cardiac pacemaker, (3) missing data, and (4) patients with COPD declined to participate in the study and controls who did not give consent to participate.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Murakami |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
980-8575
Address
2-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7874
tmurakami1123@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Murakami |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
980-8575
Address
2-1, Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
+81-22-717-7874
Homepage URL
tmurakami1123@yahoo.co.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tohoku Medical and Pharmaceutical University Wakabayashi Hospital
Address
2-29-1, Yamatomachi, Wakabayashi-ku, Sendai, MIyagi
Tel
+81-22-236-5911
medi-ethics@hosp.tohoku-mpu.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 | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.resinv.2024.05.012
Number of participants that the trial has enrolled
117
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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 12 | 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
This study is an observational cross-sectional study.
Management information
Registered date
| 2024 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061296
