UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058955 |
|---|---|
| Receipt number | R000067410 |
| Scientific Title | Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure: A randomized controlled trial |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/02 08:30:43 |
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Basic information
Public title
Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure
Acronym
Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure
Scientific Title
Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure: A randomized controlled trial
Scientific Title:Acronym
Effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure: A randomized controlled trial
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of combined cognitive training and comprehensive cardiac rehabilitation on mild cognitive impairment in older patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Montreal Cognitive Assessment (MoCA-J) [Time Frame: Measured at baseline and discharge]
Key secondary outcomes
Self-Care of Heart Failure Index (SCHFI), Hospital Anxiety and Depression Scale (HADS), Short Physical Performance Battery (SPPB), Handgrip strength, Gait speed [Time Frame: Measured at baseline and discharge]
Rehospitalization rates and Major Adverse Cardiovascular Events (MACE) measured at 12 months [Time Frame: Measured as events occur during the lifespan of the trial]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1) Usual care
2) Exercise therapy (20-40 minutes per day, 5 days per week)
3) Cognitive training (20 minutes per day, 5 days per week)
4) Diet therapy, Disease management counseling, Vascular risk monitoring
Interventions/Control_2
1) Usual care
2) Exercise therapy (20-40 minutes per day, 5 days per week)
3) Diet therapy, Disease management counseling, Vascular risk monitoring
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) Patients who were hospitalized for heart failure and conducted rehabilitation
2) Aged 65 years or older
3) Patient who were mild cognitive impairment (Japanese version of the Montreal Cognitive
Assessment: 17-22 points)
Key exclusion criteria
1) Patients whose consent was not obtained
2) Acute coronary syndrome
3) Severe symptomatic aortic stenosis, mitral stenosis, and hypertrophic obstructive cardiomyopathy
4) Patients undergoing hemodialysis
5) Requiring high inotropic support
6) Patients with circulatory assist device
7) Short life expectancy due to advanced disease other than heart failure
8) Patients who could not walk without total assistance
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kodai |
| Middle name | |
| Last name | Ishihara |
Organization
Konan Women's University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
2-23 Morikitamachi 6-chome, Higashinada-ku, Kobe, Japan
TEL
078-413-3684
mhe1601@std.huhs.ac.jp
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Ishihara |
Organization
Konan Women's University
Division name
Department of Physical Therapy, Faculty of Nursing and Rehabilitation
Zip code
658-0001
Address
2-23 Morikitamachi 6-chome, Higashinada-ku, Kobe, Japan
TEL
078-413-3684
Homepage URL
mhe1601@std.huhs.ac.jp
Sponsor or person
Institute
Konan Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sakakibara Heart Institute of Okayama, Kobe University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board of the Konan Women's University
Address
2-23 Morikitamachi 6-chome, Higashinada-ku, Kobe, Japan
Tel
078-413-3972
gakuken@konan-wu.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
心臓病センター榊原病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067410
