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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036123
Receipt No. R000041151
Scientific Title Cardiac rehabilitation focused on physical function of acute decompensated heart failure
Date of disclosure of the study information 2019/03/18
Last modified on 2019/03/18

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Basic information
Public title Cardiac rehabilitation focused on physical function of acute decompensated heart failure
Acronym PEARL study
Scientific Title Cardiac rehabilitation focused on physical function of acute decompensated heart failure
Scientific Title:Acronym PEARL study
Region
Japan

Condition
Condition Acute decompensated heart failure
Classification by specialty
Cardiology Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of rehabilitation focusing on physical functions for acute decompensated heart failure patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short Physical Performance Battery(Evaluation until the 5th hospital day and at discharge or between the 14th and 21th hospital days)
Key secondary outcomes 1:Grip strength, isometric knee extension strength, gait speed(Evaluation until the 5th hospital day and at discharge or between the 14th and 21th hospital days)
2:Timed Up & Go Test (TUG), single leg standing time, 6 minutes walking(Evaluation at discharge or between the 14th and 21th hospital days)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1:Cardiac rehabilitation standard program for heart failure, 20-40 minutes per day, 5 days per week
2:Resistance training starting from low intensity(Start from 1RM 30%)
3:Ergometer starting from low strength(1 minute 3 sets, break time 2 minutes)

Interventions/Control_2 Cardiac rehabilitation standard program for heart failure, 20-40 minutes per day, 5 days per week
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1:60 years-old
2:Walkable before hospitalization
3:No life crisis due to terminal disease (cancer etc.)
4:With the exception of PCI, there are no plans for valve replacement, CABG, or other surgery
5:No severe dementia
Key exclusion criteria 1:All evaluation items can not be extracted
2:Death during hospitalization
3:NT-proBNP < 400 pg/ml at admission
4:Cognitive dysfunction
5:Acute coronary syndrome
6:Significant myocardial ischemia during low-intensity exercise
7:Resting heart rate > 120/min
8:Acute infective endocarditis, myocarditis, and pericaritis
9:Presence of a recent hospitalization for heart failure (< 1 month)
10:Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy
11:Severe pulmonary hypertension
12:Intracardiac thrombus
13:Untreated life-threatening arrhythmia
14:Resting blood pressure > 180 mmHg
15:Ongoing orthopnea
16:Requiring high inotropic support
17:Patients with circulatory assist device
18:A therapeutic device (extracorporeal pacemaker), an intravenous drip is inserted in the inguinal neck
19:Patients with inadequate oxygenation
20:Patients with mechanical ventilation
21:History of aortic dissection, or presence of aortic aneurysm or aortic dissection
22:Patients with uncontrolled diabetes
23:Peripheral arterial disease (Fontain 3-4)
24:Recent embolism
25:Patients undergoing hemodialysis
26:Serum creatinine > 3.0 mg/dl
27:Severe anemia
28:Patients who are not suitable for participation at doctors discretion
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Yuta
Middle name
Last name Nakaya
Organization Uwajima City Hospital
Division name Department of Rehabilitation
Zip code 798-8510
Address 1-1 Goten-machi, Uwajima city, Ehime
TEL 0895-25-1111
Email y.nakaya.pt@gmail.com

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Nakaya
Organization Uwajima City Hospital
Division name Department of Rehabilitation
Zip code 798-8510
Address 1-1 Goten-machi, Uwajima city, Ehime
TEL 0895-25-1111
Homepage URL
Email y.nakaya.pt@gmail.com

Sponsor
Institute Uwajima City Hospital
Department of Rehabilitation
Institute
Department

Funding Source
Organization None
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 Uwajima City Hospital
Address 1-1 Goten-machi, Uwajima city, Ehime
Tel 0895-25-1111
Email y.nakaya.pt@gmail.com

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 市立宇和島病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 18 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
2018 Year 10 Month 01 Day
Date of IRB
2019 Year 01 Month 21 Day
Anticipated trial start date
2019 Year 03 Month 18 Day
Last follow-up date
2020 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 07 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041151

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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