UMIN-CTR Clinical Trial

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
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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
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
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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
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Results
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Results Delayed
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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
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
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Research case data
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