UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 11 Month 15 Day
Date of IRB	2017 Year 12 Month 28 Day
Anticipated trial start date	2018 Year 01 Month 01 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	2020 Year 04 Month 07 Day

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