UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036757 |
|---|---|
| Receipt number | R000032120 |
| Scientific Title | Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure- |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2019/09/12 11:44:45 |
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Basic information
Public title
Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Acronym
Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Scientific Title
Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Scientific Title:Acronym
Effects of electrical stimulation on neuromuscular muscle on quadriceps muscle thickness-A trial for patients with acute heart failure-
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of neuromuscular electrical stimulation on quadriceps muscle thickness in patients with acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quadriceps muscle thickness every week from the start of physical therapy
Key secondary outcomes
Lower leg muscle strength, SPPB, 6MD, grip strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
In addition to regular rehabilitation, neuromuscular electrical stimulation plus voluntary contraction is performed 30 minutes a day, 5 times a week until discharge.
Interventions/Control_2
Implement regular rehabilitation.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Person who corresponds to Framingham criteria
Person who is BNP400pg / ml or more at admission
Those who have NYHA III to IV level at admission
Person who is under LVEF 40% at admission
Person who was able to walk before hospitalization
Key exclusion criteria
Person who is calmed down
Those who are operating implanted electrodes such as pacemakers
Those who show loss of sensation in the lower limbs
Those who have open wounds or skin allergic symptoms at the treatment site
A person who explained the purpose of this study and did not obtain written consent from the patient or the representative
A person who is judged inappropriate as a subject by the doctor in charge or research director
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | yuki |
| Middle name | |
| Last name | kakimoto |
Organization
Otemae Hospital
Division name
Division of physical medicine and rehabilitation
Zip code
540-0008
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL
06-6941-0484
y.kakimoto29@outlook.com
Public contact
Name of contact person
| 1st name | yuki |
| Middle name | |
| Last name | kakimoto |
Organization
Otemae Hospital
Division name
Clinical Research Center Clinical Trials Office
Zip code
540-0008
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
TEL
06-6941-0484
Homepage URL
y.kakimoto29@outlook.com
Sponsor or person
Institute
Otemae Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Otemae Hospital
Address
1-5-34 Otemae, Chuo-ku, Osaka City, Osaka Prefecture
Tel
06-6941-0484
info@otemae.gr.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
大手前病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032120
| 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 |
