UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057833 |
|---|---|
| Receipt number | R000066106 |
| Scientific Title | Association of perioperative lower limb muscle mass with physical function and quality of life in patients after cardiovascular surgery: A multicenter prospective observational study |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/12 07:41:07 |
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Basic information
Public title
Japan-Perioperative Evaluation of musculoskeletal ultrasound and physical function in Cardiac Surgery
Acronym
J-PECS study
Scientific Title
Association of perioperative lower limb muscle mass with physical function and quality of life in patients after cardiovascular surgery: A multicenter prospective observational study
Scientific Title:Acronym
J-PECS study
Region
| Japan |
Condition
Condition
valvular heart disease
coronary arterial disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of preoperative lower limb skeletal muscle mass with physical function and quality of life at hospital discharge.
Basic objectives2
Others
Basic objectives -Others
To investigate the association of preoperative lower limb skeletal muscle mass with physical function and quality of life at 30 days and 180 days after surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index and EuroQol 5 dimensions 5-level at hospital discharge
Key secondary outcomes
Barthel Index and EuroQol 5 dimensions 5-level at 30 days and 180 days after ICU discharge
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing planned open heart surgery for valvular heart disease or coronary artery disease
Key exclusion criteria
Reoperation
Two-stage operation
catheter surgery (TAVI, MitraClip)
minimally invasive cardiac surgery
Patients who have difficulty walking independently before surgery
preoperative Barthel index less than 70 points
Patients with motor paralysis due to pre-existing cerebrovascular disease
Patients with dementia or mental illness with communication difficulties
Patients with serious postoperative complications such as cerebral or myocardial infarction
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
tanaka.kohei30@oim.or.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka International Medical & Science Center
Division name
Department of Rehabilitation Medicine
Zip code
543-8922
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
Homepage URL
tanaka.kohei30@oim.or.jp
Sponsor or person
Institute
Osaka International Medical & Science Center
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Police Hospitals Ethics Committee
Address
2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan
Tel
06-6771-6051
tiken-jim@oim.or.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
| 2025 | Year | 05 | Month | 12 | 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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We wil collect information on outcomes about the patient's condition prospectively during the perioperative period.
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066106
