UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029941 |
|---|---|
| Receipt number | 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 | 2020/04/07 16:56:03 |
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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
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
taniguch@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034025
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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