UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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
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


Contact us.