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 2023/12/04 18:05:18

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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

Email

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


Email

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

Email

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

Preinitiation

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

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.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