UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035071 |
|---|---|
| Receipt number | 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 | 2024/12/03 20:03:11 |
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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 | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine,
Zip code
3710004
Address
3-12, Kameizumi, Maebashi,Gunma,Japan
TEL
027-269-7455
inokuma-m@cvc.pref.gunma.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine,
Zip code
371-0004
Address
3-12, Kameizumi, Maebashi,Gunma,Japan
TEL
027-269-7455
Homepage URL
inokuma-m@cvc.pref.gunma.jp
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center
Division of Rehabilitation Medicine
Institute
Department
Personal name
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
Gunma Prefectural Cardiovascular Center
Address
3-12, Kameizumi, Maebashi,Gunma,Japan
Tel
027-269-7455
inokuma-m@cvc.pref.gunma.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
| 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
| Delay expected |
Results Delay Reason
Papers under review
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 | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Submitted to Journal of Cardiac Rehabilitation, acsept, published in Japanese Journal of Cardiac Rehabilitation, vol. 29, no. 3 & 4, p. 264-269.
Management information
Registered date
| 2018 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039733
