UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034790 |
|---|---|
| Receipt number | R000039558 |
| Scientific Title | Verification of muscle strengthening effect of Neuromuscular electrical stimulation using wearable small electric stimulation device in patients with stable COPD: randomized controlled trials |
| Date of disclosure of the study information | 2018/11/07 |
| Last modified on | 2022/11/09 09:44:10 |
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Basic information
Public title
Verification of muscle strengthening effect of Neuromuscular electrical stimulation using wearable small electric stimulation device in patients with stable COPD: randomized controlled trials
Acronym
SIXPAD STUDY
Scientific Title
Verification of muscle strengthening effect of Neuromuscular electrical stimulation using wearable small electric stimulation device in patients with stable COPD: randomized controlled trials
Scientific Title:Acronym
SIXPAD STUDY
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed to clarify the effect of muscular strength training of myoelectric electric stimulation using wearable small electric stimulation device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is fat free mass index, and it is investigated before intervention 8 week and 6 months.
Key secondary outcomes
The secondary endpoint is fat free mass index, right upper limb muscle mass, left upper limb muscle mass, right lower limb muscle mass, left lower limb muscle mass, total muscle mass,% VC,% FEV1,FEV 1%,% FVC, step, METs, MVPA,6 minutes walking distance,WBI, grip, walking speed (m / sec), right upper limb circumference, left upper limb circumference, right circumference of right leg, left lower limb circumference, body weight,BMI, NRADL, CAT, m-MRC are investigated before intervention 8 weeks and 6 months.
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuromuscular electric stimulation is warmed up for 3 minutes, stimulation for 20 minutes (setting of electrical stimulation is a symmetrical biphasic rectangular pulse current of 20 Hz, the pulse width is 0.001 msec. The duty cycle is 3 seconds on at 20 Hz, 2 seconds off at 0 Hz in the first phase, 3 seconds on at 20 Hz at 2 Hz, 2 s off at 4 Hz in the second phase, 4 seconds on at 20 Hz, 2 seconds off at 4 Hz
in the third phase, 5 seconds on at 20 Hz, 2 seconds off at 4 Hz in the fourth phase) 3 times per week in a period of 8 weeks. / Ergometer (20 minutes at 40% exercise intensity of peak watt measured by CPX) was conducted three times per week for a period of 8 weeks. / Upper limb strength training (3 sets of arm curls with a 1 kg weight) was conducted three times a week for 8 weeks. / Lower limb strength training (5 sets of standing training 10 cm from the seat surface of 40 cm height) was conducted three times per week for a period of 8 weeks.
Interventions/Control_2
A ergometer (20 minutes at 40% exercise intensity of peak watt measured by CPX) was performed in eight weeks with three weekly runs. / Upper limb strength training (3 sets of arm curls with a 1 kg weight) was conducted three times a week for 8 weeks. / Lower limb strength training (5 sets of standing training 10 cm from the seat surface of 40 cm height) was conducted three times per week for a period of 8 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient who has visited a respiratory center with COPD and has been able to continue rehabilitation for 8 weeks in hospital or outpatient at the discretion of a doctor.
Diagnostic criteria for COPD are in accordance with 2017 GOLD.
Key exclusion criteria
Patients with central and peripheral neuropathy, progressive cancer, using cardiac pacemakers, contraindicated for cardiopulmonary exercise test
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Hataji |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory center
Zip code
515-8544
Address
1550 Tonomachi, Matsusaka City, Mie
TEL
0598-23-1515
pthiroyuki1988@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takemura |
Organization
Matsusaka Municipal Hospital
Division name
Department of Rehabilitation
Zip code
515-8544
Address
1550 Tonomachi, Matsusaka City, Mie
TEL
0598-23-1515
Homepage URL
pthiroyuki1988@gmail.com
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
No research funds are provided for the implementation of this research
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
Matsusaka Municipal Hospital
Address
1550 Tonomachi, Matsusaka City, Mie
Tel
0598-23-1515
mchkuraguchi@city-hosp.matsusaka.mie.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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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 | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039558
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