UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053848 |
|---|---|
| Receipt number | R000060322 |
| Scientific Title | Efficacy and safety of home-based cardiac rehabilitation in patients with left ventricular assist devices: a single-arm study. |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 11:49:55 |
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Basic information
Public title
Efficacy and safety of home-based cardiac rehabilitation in patients with left ventricular assist devices: a single-arm study.
Acronym
LVAD-HomeReha study
Scientific Title
Efficacy and safety of home-based cardiac rehabilitation in patients with left ventricular assist devices: a single-arm study.
Scientific Title:Acronym
LVAD-HomeReha study
Region
| Japan |
Condition
Condition
Left ventricular assist device
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of home-based cardiac rehabilitation in patients with left ventricular assist devices.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Peak VO2
Key secondary outcomes
Change in AT, Peak watt and VE/VCO2 slope
Change in KCCQ
Change in number of steps, physical activity and 5m walk speed
Change in muscle (grip strength, knee extension muscle strength and respiratory muscle strength)
Change in anxiety and depression
Change in FAI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Wear a wearable device for 90 days to manage physical activity while providing disease management, exercise and nutritional guidance
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Discharged from the hospital for more than 3 months
2. Agreement
3. Age 20 years and older
Key exclusion criteria
1. Patients with difficulty measuring exercise tolerance due to musculoskeletal disease
2. Patients with re-hospitalization for acute exacerbation of heart failure within 1 month
3. Patients who do not have their own smartphone
4. Patients who are determined by the study investigator, study sponsor, or attending physician to be inappropriate as study subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ide |
Organization
Kyushu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5360
ide.tomomi.117@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nezu |
Organization
Kyushu University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5862
Homepage URL
nezu.tomoyuki.303@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Center for Clinical and Translational Research, Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.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
| 2024 | Year | 03 | Month | 13 | 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
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060322
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
