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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029941
Receipt No. R000034025
Scientific Title Continuity of home-based cardiac rehabilitation using remotely controlled cycling exercise system in retired elderly patients with heart failure: A pilot study
Date of disclosure of the study information 2017/11/20
Last modified on 2019/02/10

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Basic information
Public title Continuity of home-based cardiac rehabilitation using remotely controlled cycling exercise system in retired elderly patients with heart failure: A pilot study
Acronym Home-based cardiac rehabilitation using remotely controlled cycling exercise system
Scientific Title Continuity of home-based cardiac rehabilitation using remotely controlled cycling exercise system in retired elderly patients with heart failure: A pilot study
Scientific Title:Acronym Home-based cardiac rehabilitation using remotely controlled cycling exercise system
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate feasibility, safety and compliance of remotely supervised home-based cardiac rehabilitation in retired elderly patients with heart failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Feasibility, safety and compliance of home-based cardiac rehabilitation using remotely controlled exercise system
Key secondary outcomes Change in exercise tolerance such as peak VO2 and results of 6 minutes walk test after home-based cardiac rehabilitation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 remotely supervised home-based exercise
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.HF patients who were diagnosed as HF according to the guideline from European Society of Cardiology 2016
2.patients who are recommended to home-based exercise
3.patients who can not or do not want to visit center-based cardiac rehabilitation
4.Over 65 years old
5.patients who do not have regular job
Key exclusion criteria 1.patients who can not push pedals of cycling system due to other diseases or pain
2.patients who can participate center-based cardiac rehabilitation more than two sessions a week
3.patients who experienced decrease in blood pressure, fetal arrhythmia or other adverse events (eg. chest pain, dyspnea, syncope, vertigo, dizziness, leg pain, cyanosis, pallor, cold sweat, ataxia, hypotension, hypertension)
4.AMI patients within 3 months after onset, severe aortic stenosis, end-stage HF, end-stage renal failure (estimated GFR <20 ml/min/1.73m2), other end-stage disease
5.patients with residual myocardial ischemia
6.patients who have a risk for HF worsening due to exercise
7.post implantation of pacemaker or left ventricular assist device
8.dementia
9.patients living alone
10.patients without consent
11.patients who are not considered to be appropriate by attending physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Sakata
Organization Osaka University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-15 Yamada-oka, Suita city, Osaka
TEL 06-6879-5111
Email yasushisk@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Taniguchi
Organization Osaka University Graduate School of Medicine
Division name Department of Biodesign for Healthcare Innovation
Zip code
Address 1-3 Yamada-oka, Suita city, Osaka
TEL 06-6105-5249
Homepage URL
Email taniguch@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 11 Month 20 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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 23 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 12 Day
Last modified on
2019 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034025

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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