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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035071
Receipt No. R000039733
Scientific Title The effect of skeletal muscle electrical stimulation therapy in patients with heart disease
Date of disclosure of the study information 2018/11/30
Last modified on 2018/11/29

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Basic information
Public title The effect of skeletal muscle electrical stimulation therapy in patients with heart disease
Acronym SMHT study
Scientific Title The effect of skeletal muscle electrical stimulation therapy in patients with heart disease
Scientific Title:Acronym SMHT study
Region
Japan

Condition
Condition heart disease
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider the effect of exsecise therapy with skeletal muscle electrical stimulation vs exsecise in patients with heart disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Absolute value of knee extension muscle force
Key secondary outcomes Flexural strength, quadriceps muscle thickness, 6-minute walk test, amout of lower limb muscle, anaerobic threshold,peak oxygen uptake

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In the intervention group, skeletal muscle stimulation therapy and exercise therapy using Panasonic knee trainer (EU - JLM 50 S) are used in combination. Contents of exercise therapy will be carried out 2 minutes of aerobic exercise with an anaerobic metabolic threshold using Senoh cordless bike V after preparatory exercise for 10 minutes before exercise.More than 2 times a week, 5 months intervention.
Interventions/Control_2 The control group carries out ordinary exercise therapy.
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Heart disease patients who participate in outpatient exercise therapy more than twice a week
Key exclusion criteria Patients with visit frequency of 2 times / week or less, patients with advanced orthopedic disease and advanced paralysis and bicycle ergometer can not be performed
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Inokuma
Organization Gunma Prefectural Cardiovascular Center
Division name Division of Rehabilitation Medicine,
Zip code
Address 3-12, Kameizumi, Maebashi,Gunma,Japan
TEL 027-269-7455
Email inokuma-m@cvc.pref.gunma.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Inokuma
Organization Gunma Prefectural Cardiovascular Center
Division name Division of Rehabilitation Medicine,
Zip code
Address 3-12, Kameizumi, Maebashi,Gunma,Japan
TEL 027-269-7455
Homepage URL
Email inokuma-m@cvc.pref.gunma.jp

Sponsor
Institute Gunma Prefectural Cardiovascular Center
Division of Rehabilitation Medicine
Institute
Department

Funding Source
Organization Panasonic
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 30 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
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 12 Day
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
2018 Year 11 Month 29 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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