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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000042480 |
Receipt No. | 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 | 2020/11/17 |
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 |
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Condition | ||
Condition | cardiovascular disease | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. patients aged 65 years old or older
2. patients with informed consent of this study |
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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 |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Juntendo University Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | none |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048491 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |