UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022144 |
|---|---|
| Receipt number | R000025269 |
| Scientific Title | Effects of Phase II cardic rehabilitation on cardio-renal function and physio-psychological function in elderly cardiac patients over 75 years old |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2021/04/29 19:49:32 |
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Basic information
Public title
Effects of Phase II cardic rehabilitation on cardio-renal function and physio-psychological function in elderly cardiac patients over 75 years old
Acronym
Effects of Phase II cardic rehabilitation on cardio-renal function and other functions in elderly cardiac patients
Scientific Title
Effects of Phase II cardic rehabilitation on cardio-renal function and physio-psychological function in elderly cardiac patients over 75 years old
Scientific Title:Acronym
Effects of Phase II cardic rehabilitation on cardio-renal function and other functions in elderly cardiac patients
Region
| Japan |
Condition
Condition
cardiac diseases
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the effects of outpatient phase II cardiac rehabilitation on cardio-renal function and physical-psychological function in the elderly patients with cardiac diseases over 75 years old
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical fitness renal function
Key secondary outcomes
Hospital Anxiety and Depression Scale Patient Health Questionnaire-9:PHQ-9
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
0ver 75 years old cardiac rehabilitation participation
Interventions/Control_2
0ver 75 years old cardiac rehabilitation no-participation
Interventions/Control_3
less than 75 years old cardiac rehabilitation participation
Interventions/Control_4
less than 75 years old cardiac rehabilitation no-participation
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)cardiac patients admitted in Ota Nishinouchi Hospital
2)with informed consent
Key exclusion criteria
1)hemodyalisis
2)Activity of daily living is not independent
3)apparant dementia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kohzuki |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7351
kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Sasamoto |
Organization
Tohoku University
Division name
Graduate School of Medicine
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai
TEL
090-9032-4202
Homepage URL
ssmty@globe.ocn.jp
Sponsor or person
Institute
Department of Internal Medicine and Rehabilitation Science, Tohoku Univeristy Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine and Rehabilitation Science, Tohoku Univeristy Graduate School 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
Ethics Committees of Tohoku University School of Medicine
Address
1-1, Seiryo-cho, Aoba-ku, Sendai
Tel
022-717-8006
med-kenkyo@grp.tohoku.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
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/85/5/85_CJ-20-0970/_article/-char/en
Number of participants that the trial has enrolled
136
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
| 2016 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 04 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025269
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
