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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034790
Receipt No. R000039558
Official scientific title of the study 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 2018/11/01

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Basic information
Official scientific title of the study Verification of muscle strengthening effect of Neuromuscular electrical stimulation using wearable small electric stimulation device in patients with stable COPD: randomized controlled trials
Title of the study (Brief title) 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, most graph, peak oxygen uptake, anaerobic threshold point, 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, SGRQ, 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 Osamu Hataji
Organization Matsusaka Municipal Hospital
Division name Respiratory center
Address 1550 Tonomachi, Matsusaka City, Mie
TEL 0598-23-1515
Email pthiroyuki1988@gmail.com

Public contact
Name of contact person Hiroyuki Takemura
Organization Matsusaka Municipal Hospital
Division name Department of Rehabilitation
Address 1550 Tonomachi, Matsusaka City, Mie
TEL 0598-23-1515
Homepage URL
Email pthiroyuki1988@gmail.com

Sponsor
Institute Matsusaka Municipal Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 05 Day
Anticipated trial start date
2018 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039558

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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