UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062624 |
|---|---|
| Receipt number | R000071687 |
| Scientific Title | Effects of an Activity Monitor-Based Discharge Support Program on Physical Activity After Hospital Discharge in Older Patients with Heart Failure: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/19 21:08:24 |
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Basic information
Public title
Effects of an Activity Monitor-Based Discharge Support Program on Physical Activity in Older Patients with Heart Failure After Hospital Discharge
Acronym
Activity Monitor-Based Discharge Support Study
Scientific Title
Effects of an Activity Monitor-Based Discharge Support Program on Physical Activity After Hospital Discharge in Older Patients with Heart Failure: A Randomized Controlled Trial
Scientific Title:Acronym
Activity Monitor-Based Discharge Support Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effects of an activity monitor-based discharge support program on physical activity after hospital discharge in older patients with heart failure, compared with usual discharge support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
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
Participants in the intervention group will receive an activity monitor-based discharge support program during hospitalization. The program will be provided once, for approximately 20 minutes, after the participant has been weaned from catecholamine agents or has become able to walk. The program will include individualized feedback on physical activity data obtained from an activity monitor, goal setting based on the participant's current physical activity level and resting heart rate, and behavioral planning to promote physical activity after hospital discharge. Participants will receive guidance on walking and simple resistance exercises, such as squats and calf raises, and will be encouraged to self-monitor their physical activity. The intervention will be provided in addition to usual cardiac rehabilitation and discharge support.
Interventions/Control_2
Participants in the control group will receive usual cardiac rehabilitation and standard discharge support during hospitalization. Standard discharge support will include general guidance on heart failure management, medication adherence, diet, exercise, and daily activities according to routine clinical practice and the cardiac rehabilitation guidelines. No activity monitor-based individualized feedback or additional behavioral planning will be provided.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients will be eligible for this study if they are aged 65 years or older, have been admitted to our hospital due to acute exacerbation of heart failure, are eligible for cardiovascular rehabilitation, and have been prescribed rehabilitation by a physician.
In accordance with the guidelines for cardiac rehabilitation, eligible patients must be hemodynamically stable and have been cleared to participate in exercise therapy. In addition, participants must be able to understand the study procedures, be able to participate in the discharge support program, and provide written informed consent to participate in the study.
Key exclusion criteria
1. Patients who meet any of the contraindications to exercise therapy specified in the Guidelines for Cardiac Rehabilitation.
2. Patients who have difficulty walking and are unable to undergo physical activity assessment. The use of walking aids and partially assisted walking are permitted.
3. Patients classified as New York Heart Association (NYHA) functional class IV.
4. Patients with suspected cognitive impairment (Mini-Cog score <2).
5. Patients who are unable to provide informed consent to participate in this study.
6. Patients for whom continued participation in the study is deemed difficult due to medical reasons or other circumstances after study initiation.
7. Patients who die during hospitalization.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Fujita |
Organization
Ibaraki Prefectural University
Division name
Department of Occupational Therapy, Faculty of Health Sciences
Zip code
3000394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
TEL
029-840-2220
fujita@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Aiba |
Organization
Ushiku-Aiwa General Hospital
Division name
Rehabilitation Center
Zip code
3001296
Address
896 Shishikocho, Ushiku, Ibaraki, Japan
TEL
0298733126
Homepage URL
ts.16.am@icloud.com
Sponsor or person
Institute
Ibaraki Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki, Japan
Tel
029-888-4000
N/A
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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071687
