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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024443
Receipt No. R000027824
Scientific Title Effect of Belt electrode - Skeletal muscle Electrical Stimulation (B-SES) on physical performance in COPD patients
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/26

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Basic information
Public title Effect of Belt electrode - Skeletal muscle Electrical Stimulation (B-SES) on physical performance in COPD patients
Acronym Effect of Electrical Muscle Stimulation in COPD
Scientific Title Effect of Belt electrode - Skeletal muscle Electrical Stimulation (B-SES) on physical performance in COPD patients
Scientific Title:Acronym Effect of Electrical Muscle Stimulation in COPD
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the improvement of the physical function in COPD patients by home-based therapy program using an electric muscle stimulation (EMS) method called Belt electrode Skeletal muscle Electrical Stimulation (B-SES)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of the lower limb / knee extension muscle strength after 12 weeks of intervention
Key secondary outcomes Change in the physical function (handgrip strength, gait speed, 6 min walk test), quality of life (CAT-COPD Assesment Test), ADL (ADL-D score)and COPD grade (modified BORG scale, BODE index) after 12 weeks of intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The control group will carry out only exercise according to the instructions of a home-based exercise program for 24 weeks.
Interventions/Control_2 The intervention group will carry out sessions of Belt electrode Skeletal muscle Electrical Stimulation (B-SES) once every day for the first 12 weeks along with the same exercise in the control group for 24 weeks.
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed as COPD by a physician.
2. modified MRC Grade; 1 to 3
3. disease condition stable by standard treatment
4. regular outpatient
5. acquisition of written informed consent
Key exclusion criteria 1.Difficulties to walk due to musculoskeletal abnormality or neurological disease.
2.use of steroidal anti-inflammatory drugs in the past 6 weeks (oral prednisone more than 20mg/day)
3.currently on treatment of malignant disease, or cured but within 5-year disease free period
4.having completed pulmonary rehabilitation program within 6 months
5.implanted heart pacemaker
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Tsuboyama
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Sciences
Zip code
Address 53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto
TEL 075-751-3948
Email tsuboyama.tadao.4n@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Marcio Makoto Nishida
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Sciences
Zip code
Address 53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto
TEL 075-751-3935
Homepage URL
Email marcio.nishida@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization None
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
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
2016 Year 11 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2018 Year 07 Month 06 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027824

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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