UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058952 |
|---|---|
| Receipt number | R000067421 |
| Scientific Title | Development of a Therapeutic nursing care program Based on the perspective of cardiac rehabilitation for acute phase patients after open heart surgery |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/01 13:41:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a nursing care program utilizing cardiac rehabilitation for acute-phase patients after open heart surgery
Acronym
Development of a nursing care program implemented from the immediate postoperative phase after open heart surgery
Scientific Title
Development of a Therapeutic nursing care program Based on the perspective of cardiac rehabilitation for acute phase patients after open heart surgery
Scientific Title:Acronym
Development of NCCR
Region
| Japan |
Condition
Condition
ischemic heart disease
heart valve disease
Classification by specialty
| Cardiovascular surgery | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By developing and implementing a nursing care program that utilizes the perspective of cardiac rehabilitation, we will prevent complications during the acute phase following open heart surgery and support early mobilization. We will then verify whether this program shortens the time to independent walking and the length of hospital stay compared to the non-intervention group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days until independent walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Implement the developed nursing care program.
Interventions/Control_2
The non-intervention group will undergo retrospective investigation.
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
(1) Patients undergoing elective cardiac surgery in cardiovascular surgery
(2) Patients who voluntarily agreed to participate in the study
(3) Patients who are independent in their activities of daily living (ADL) prior to surgery (those who fall under ADL rank J).
Key exclusion criteria
(1) Patients without symptoms of mental illness, delirium, dementia, etc.
(2) Patients who are not able to walk independently prior to surgery
(3) Patients wearing a circulatory assist device
(4) Patients undergoing noninvasive positive pressure ventilation for the treatment of heart failure
(5) Excluding pediatric patients
(6) Patients who were unable to walk independently during their hospital stay
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | NORIKO |
| Middle name | |
| Last name | SAKODA |
Organization
DOKKYO MEDICAL UNIVERSITY
Division name
Graduate School of Nursing Science
Zip code
321-0293
Address
880,Kitakobayashi,Mibu,Tochigi.
TEL
0282-87-2489
n-sakoda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | NORIKO |
| Middle name | |
| Last name | SAKODA |
Organization
DOKKYO MEDICAL UNIVERSITY
Division name
Graduate School of Nursing Science
Zip code
321-0293
Address
880,Kitakobayashi,Mibu,Tochigi.
TEL
0282-87-2489
Homepage URL
n-sakoda@dokkyomed.ac.jp
Sponsor or person
Institute
DOKKYO MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
None
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
DOKKYO MEDICAL UNIVERSITY Nursing Research Ethics Committee
Address
880,Kitakobayashi,Mibu,Tochigi.
Tel
0282-87-2489
kkrinri@dokkyomed.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
地方独立行政法人 新小山市民病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067421
