UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032935 |
|---|---|
| Receipt number | R000037544 |
| Scientific Title | Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure |
| Date of disclosure of the study information | 2018/06/10 |
| Last modified on | 2019/12/31 02:01:41 |
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Basic information
Public title
Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Acronym
Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Scientific Title
Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Scientific Title:Acronym
Effect of neuromuscular electrical stimulation on frailty in patients with acute decompensated heart failure
Region
| Japan |
Condition
Condition
Patients who admitted for acute decompemsated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of neuromuscular electrical simulation on physical frailty in patients with acute decompensated heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10-m comfortable walking speed after 2 weeks of neuromuscular electrical stimulation intervention
Key secondary outcomes
Hand grip strength and Short Physical Performance Battery score after 2 weeks of neuromuscular electrical stimulation intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the intervention group, patients receive inpatients cardiac rehabilitation and neuromucular electrical stimulation on the bilateral quadriceps femoris and triceps for 30 minutes, five times a week, for 2 consecutive weeks. The intensities of stimulation is set to induce knee extension and ankle planter flexion.
Interventions/Control_2
The control group was exposed to the same regimen, except that the stimulation did not cause visible or palpable contractions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive adult patients who are hospitalized with decompensated heart failure and receive cardiac rehabilitation at Hirakata kohosai Hospital
Key exclusion criteria
-Patients who are not able to walk prior to admission
-Patients who are able to walk 10 m at speed of 0.83 m/sec or more
-Patients with psychiatric disease
-Patients who are not able to receive neuromusclar electrical stimulation due to severe dementia, delirium, or agitation
-Patients with peripheral arterial disease
(Fontaine classification III and IV)
-Patients with mechanical circulatory support
-Patients with neuromuscular disease
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | IWATSU |
Organization
Hirakata kohsai Hospital
Division name
Department of Rehabilitation
Zip code
573-0153
Address
1-2-1 Fujisakahigashi, Hirakata-shi, Osaka, Japan
TEL
09012353312
kotaro.m.iwatsu@gmail.com
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | IWATSU |
Organization
Hirakata kohsai Hospital
Division name
Department of Rehabilitation
Zip code
573-0153
Address
1-2-1 Fujisakahigashi, Hirakata-shi, Osaka, Japan
TEL
072-858-8233
Homepage URL
kotaro.m.iwatsu@gmail.com
Sponsor or person
Institute
Hirakata kohsai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of the Hirakata Kohsai Hospital
Address
1-2-1 Fujisakashigashimachi, Hirakata, Japan
Tel
072-858-8233
hirakoh.circ@gmail.com
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
国家公務員共済組合連合会枚方公済病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 10 | 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
59
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037544
