UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060550 |
|---|---|
| Receipt number | R000069261 |
| Scientific Title | A randomized controlled trial of the efficacy of upper limb resistance training in patients with heart failure |
| Date of disclosure of the study information | 2026/02/02 |
| Last modified on | 2026/02/02 13:35:00 |
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Basic information
Public title
A study on the effects of upper limb strength training in patients with heart failure
Acronym
A study of upper limb strength training in patients with heart failure
Scientific Title
A randomized controlled trial of the efficacy of upper limb resistance training in patients with heart failure
Scientific Title:Acronym
A randomized controlled trial of upper limb resistance training in patients with heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of upper limb resistance training for patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index
Key secondary outcomes
Katz Index,Lowton Index,Functional Independence Measure,PMADL-8,Hand held Dynamometer,Hand grip strength,pinch strength,Simple for Test Evaluating Hand Function(STEF),Short Physical Performance Battery(SPPB),Mini Mental State Examination(MMSE),Self Care of Heart Failure Index(SCHFI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will be divided into two groups: one that performs upper and lower limb resistance training, and one that performs lower limb resistance training only, and will undergo rehabilitation for 2-3 weeks.
Interventions/Control_2
The upper and lower limb resistance training group performed upper limb resistance training three times a week and lower limb resistance training on the other 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
1.Heart failure patients
2.Age and gender not specified
3.Written informed consent from the individual or legal representative to participate in this study
Key exclusion criteria
1.Individuals who do not consent to this study.
2.Individuals with New York Heart Association (NYHA) classification IV.
3.Individuals who underwent invasive treatment during hospitalization (e.g.transcatheter aortic valve implantation, Mitra Clip, surgery).
4.Individuals with serious comorbidities or complications other than cardiac disease.
5.Individuals with severe dementia (Mini-Mental State Examination (MMSE) score<=10).
6.Individuals undergoing dialysis.
7.Individuals with severe limitations in upper and lower limb function due to neurological or orthopedic disorders.
8.Individuals undergoing cardiac rehabilitation for a prolonged period exceeding four weeks.
9.Individuals who required full assistance or close to full assistance in ADLs before hospitalization.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Department of Rehabilitation Medicine
Division name
Department of Rehabilitation Medicine
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
022-717-7353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Masuda |
Organization
Tohoku University
Division name
Department of Rehabilitation Medicine, Tohoku University Graduate School of Medicine
Zip code
980-8574
Address
Seiryo-machi 1-1, Aoba-ku, Sendai
TEL
022-717-7353
Homepage URL
masuda.daiki.s1@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2026 | Year | 02 | Month | 02 | 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 | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | 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 | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069261
