UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045268 |
|---|---|
| Receipt number | R000051707 |
| Scientific Title | Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/26 08:39:41 |
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Basic information
Public title
Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Acronym
Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Scientific Title
Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Scientific Title:Acronym
Effect of preoperative rehabilitation for elderly patients awaiting elective coronary artery bypass and valvular surgery with frailty
Region
| Japan |
Condition
Condition
Ischemic heart disease
Valvular heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the effect of preoperative rehabilitation for elderly patients awaiting cardiac surgery with frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Cardiovascular Health Study (J-CHS) standard, Short Physical Performance Battery (SPPB), and 6-minute walking test are evaluated before and after the preoperative rehabilitation intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Perform rehabilitation interventions 2-3 times a week. Time is 60 minutes each time, exercise intensity is HR at AT (anaerobic threshold) calculated by cardiopulmonary exercise test, or 40-60% HRR (Heart Rate Reserve), PRE (Rate of Perceived exertion) 12- Let it be 13.
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
Elective surgery for coronary artery bypass or mitral valve replacement/plasty
65 years of age or older
frail or pre-frail
Preoperative examination No ischemic symptoms or abnormal vital signs are observed below AT in the exercise stress test
Key exclusion criteria
NYHA IV
Exacerbation of subjective symptoms of heart failure within 1 week
Unstable angina
Untreated exercise-induced arrhythmia
Severe aortic valve stenosis
Severe left ventricular outflow tract stenosis
Ischemic symptoms or abnormal vital signs below AT
Cognitive dysfunction
ADL is not independent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo college of medicine
Division name
Department of rehabilitation medicine
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456111
domen@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Honda |
Organization
Hospital of Hyogo college of medicine
Division name
Department of rehabilitation
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456111
Homepage URL
yosuke12@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo college of medicine
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
Hyogo college of medicine
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel
0798456066
rinri@hyo-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 | 10 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | 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
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051707
