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 2020/11/17 15:23:01

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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

Email

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


Email

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

Email

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

2025 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

2020 Year 11 Month 17 Day



Link to view the page

Value
https://center6.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