UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044925 |
|---|---|
| Receipt number | R000051273 |
| Scientific Title | The Effect of Preoperative Frailty on Postoperative Physical Activity in Patients with Cardiac Implanted electric Devices |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2025/07/24 05:57:48 |
* 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
The Effect of Preoperative Frailty on Postoperative Physical Activity in Patients with Cardiac Implanted electric Devices
Acronym
The Effect of Preoperative Frailty on Postoperative Physical Activity in Patients with Cardiac Implanted electric Devices
Scientific Title
The Effect of Preoperative Frailty on Postoperative Physical Activity in Patients with Cardiac Implanted electric Devices
Scientific Title:Acronym
The Effect of Preoperative Frailty on Postoperative Physical Activity in Patients with Cardiac Implanted electric Devices
Region
| Japan |
Condition
Condition
Cardiac implantable electrical devises implantation (pacemakers, implantable cardioverter defibrillator, Cardiac Resynchronization Therapy)
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether pre-hospital frailty affects the amount of postoperative physical activity.
Basic objectives2
Others
Basic objectives -Others
To investigate whether pre-hospital frailty status influences heart failure readmission.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity, frailty
Key secondary outcomes
Readmission
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have undergone pacemaker, ICD, CRT-P, CRT-D implantation or battery replacement
(2) 65 years old or older at the time of the subject period.
Key exclusion criteria
UUnder 65 years old in the applicable period
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan.
TEL
042-984-4367
tonsuke.tomo2@gmail.com
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takeda |
Organization
Saitama Medical University International medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan.
TEL
042-984-4367
Homepage URL
tonsuke.tomo2@gmail.com
Sponsor or person
Institute
Saitama Medical University International medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Saitama Medical University International medical Center
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
Tel
042-984-4523
chikens@saitama-med.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
| 2021 | Year | 07 | Month | 20 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051273
