UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040136 |
|---|---|
| Receipt number | R000045767 |
| Scientific Title | Efficacy and safety of comprehensive home-based cardiac rehabilitation using ICT for heart failure patients with physical frailty: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2020/04/14 |
| Last modified on | 2022/12/16 19:46:38 |
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Basic information
Public title
Efficacy and safety of comprehensive home-based cardiac rehabilitation using ICT for heart failure patients with physical frailty: A Randomized Controlled Trial.
Acronym
HomeReha study
Scientific Title
Efficacy and safety of comprehensive home-based cardiac rehabilitation using ICT for heart failure patients with physical frailty: A Randomized Controlled Trial.
Scientific Title:Acronym
HomeReha study
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of a comprehensive home-based cardiac rehabilitation using ICT technology for heart failure patients with physical frailty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of changes in 6MWD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
90days
disease management
exercise instruction
nutrition guidance
Interventions/Control_2
90days
observation
For ethical reasons, the control group was observed for 90 days, followed by intervention 1(disease management, exercise instruction, nutritional guidance) for 90 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatient
Heart failure patients(NYHA2-3)
Patients with physical frailty above prefrailty
Key exclusion criteria
Patients who cannot perform 6 min walking test
Patients with severe kidney diseasee
Patients with severe cognitive decline
BMI of 25kg/m2 or more
Patients with a 6 min walking distance 550m or more
Patients participating in outpatient cardiac rehabilitation more than twice a week
Patients readmitted within 1 month
Patients who do not have smartphones
Patients judged by the investigator to be ineligible for some other reason
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
0926425371
tomomi_i@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Nagatomi |
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
nagatomi@reha.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyushu University Hospital
Address
3-1-1 Maidashi Higashi-ku Fukuoka
Tel
092-642-5774
nagatomi@reha.med.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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35534907/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35534907/
Number of participants that the trial has enrolled
30
Results
The 6 MWD increased in 3 months in the HBCR group, whereas there were no significant improvements in the control group. The change in 6 MWD at 3 months from baseline was significantly greater in the HBCR group than in the control group.
Results date posted
| 2022 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the patients was 63.7 years, 53% were men, 37% were NYHA 3 patients, and 87% had non-ischemic heart disease.
Patients with frailty accounted for 33% and the rest were pre-frail in both groups.
Participant flow
During the study, 30 out of 35 eligible patients consented to participate. 30 participants were randomized into two groups, with the intervention group receiving the intervention for 3 months. All patients were assessed at 3 months.
Adverse events
A total of 16 AE occurred, seven in the control group and nine in the HBCR group (p = 0.456). No serious AE, such as death or cardiac arrest, occurred in either group. There were three readmissions in the control group and three in the HBCR group, which were not causally related to the intervention.
Outcome measures
The primary outcome was the change in the 6 MWD at 3 months from baseline.
The secondary outcomes were 1) the change in brain natriuretic peptide (BNP), 2) the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 3) the change in Short physical performance battery (SPPB) performance, 4) the change in the Kihon Checklist (frail evaluation) scores, 5) difference of AE, and 6) exercise adherence for the HBCR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045767
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