UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024443 |
|---|---|
| Receipt number | 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 | 2020/10/20 14:04:42 |
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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 | Tadao |
| Middle name | |
| Last name | Tsuboyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
606-8501
Address
53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto
TEL
075-751-3948
tsuboyama.tadao.4n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Marcio |
| Middle name | Makoto |
| Last name | Nishida |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Sciences
Zip code
606-8501
Address
53 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto
TEL
075-751-3935
Homepage URL
marcio.nishida@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
Research Promotion Department of Kyoto University Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
Tel
075-751-4899
trans@kuhp.kyoto-u.ac.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
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://kyoto.bvits.com/rinri/Apply/finish.aspx?PROJECT_ID=2839
Publication of results
Unpublished
Result
URL related to results and publications
https://kyoto.bvits.com/rinri/Apply/finish.aspx?PROJECT_ID=2839
Number of participants that the trial has enrolled
6
Results
The planned study period has ended. During the course of the study, due to an injury to the core researcher, only 3 patients in the intervention group and 3 in the control group were enrolled and measured. The interim analysis showed no trend toward improvement in either the primary or secondary endpoints in the intervention group.
Results date posted
| 2020 | Year | 10 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
COPD patients with more than 65 years old age and with stable clinical symptoms not requiring supplementary oxygen.
Participant flow
Eligible subjects were enrolled in the study, and those who agreed to participate were randomly assigned to either control or intervention groups.
Adverse events
no adverse events
Outcome measures
Pre- and post-intervention changes in lower extremity muscle strength, changes in physical function (grip strength, walking speed, and 6-minutes　walking distance), and changes in quality of life and COPD status in the intervention group only.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 28 | Day |
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
| 2020 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027824
