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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000023712 |
Receipt No. | R000027316 |
Scientific Title | Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/08/22 |
Basic information | ||
Public title | Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients | |
Acronym | Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients | |
Scientific Title | Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients | |
Scientific Title:Acronym | Clinical studies on the effect of neuromuscular electrical stimulation therapy for heart disease patients | |
Region |
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Condition | |||
Condition | Heart disease | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the mechanism of exercise tolerance improvement effect of skeletal muscle electrical stimulation to the heart disease patients |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The 6-Min Walk Distance |
Key secondary outcomes | Pleiotropic effects on body function |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Pseudo-randomization |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 1)Cardiac rehabilitation program
2)Electrical muscle stimulation |
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Interventions/Control_2 | 1)Cardiac rehabilitation program | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients who were hospitalized for heart failure
2)65 years of age or older 3)Short Physical Performance Battery score 9 points or less |
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Key exclusion criteria | 1)Patients with pacemaker insertion
2)Dialysis patient 3)Patients with severe orthopedic diseases 4)Patient with walking disturbance 5)Patients who are ineligible by the principal investigator |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokushima Graduate School of Biomedical Sciences | ||||||
Division name | Department of Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 3-18-15 Kuramoto-cho, Tokushima-city, Tokushima | ||||||
TEL | 088-633-7851 | ||||||
syagi@tokushima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokushima University Hospital | ||||||
Division name | Departments of Rehabilitation | ||||||
Zip code | |||||||
Address | 2-50-1, Kuramoto-cho, Tokushima | ||||||
TEL | 088-633-9313 | ||||||
Homepage URL | |||||||
pt8@tokushima-u.ac.jp |
Sponsor | |
Institute | Tokushima University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Tokushima University Hospital |
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 | |
Address | |
Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027316 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |