UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042480 |
|---|---|
| Receipt number | R000048491 |
| Scientific Title | Impairments of hemodynamic responses during orthostasis and physical performance associated with clinical outcomes in frail patients with cardiovascular disease. |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2025/05/22 12:25:46 |
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Basic information
Public title
Impairments of hemodynamic responses during orthostasis and physical performance associated with clinical outcomes in frail patients with cardiovascular disease.
Acronym
Impairments of hemodynamic responses during orthostasis and physical performance associated with clinical outcomes in frail patients with cardiovascular disease.
Scientific Title
Impairments of hemodynamic responses during orthostasis and physical performance associated with clinical outcomes in frail patients with cardiovascular disease.
Scientific Title:Acronym
Impairments of hemodynamic responses during orthostasis and physical performance associated with clinical outcomes in frail patients with cardiovascular disease.
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effect of exercise-based cardiac rehabilitation on impairment of hemodynamic response during orthostasis and physical performance. Moreover, we assess prognostic impact of impairment of hemodynamic response in frail patients with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year all-cause death
Key secondary outcomes
hospitalization
fall
frailty
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patients aged 65 years old or older
2. patients with informed consent of this study
Key exclusion criteria
1. patients who could not get physicians' permission
2. patients who could not stand being alone
3. severe cognitive dysfunction (dementia)
4. pattens who could get investigators' permission
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University hospital
Division name
Department of Rehabilitation
Zip code
113-0033
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
0.-5802-1203
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Saitoh |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
503 Ochanomizu center building, 3-2-12, Hongo, Bunkyoku, Tokyo
TEL
03-3813-3111
Homepage URL
m.saito.tl@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Juntendo University Hospital Ethics Committee
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2020 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 12 | 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
none
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048491
