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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040414
Receipt No. R000046116
Scientific Title A prospective, randomized controlled trial of neuromuscular electrical stimulation in patients with interstitial lung disease
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/15

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Basic information
Public title A prospective, randomized controlled trial of neuromuscular electrical stimulation in patients with interstitial lung disease
Acronym Neuromuscular electrical stimulation in ILD
Scientific Title A prospective, randomized controlled trial of neuromuscular electrical stimulation in patients with interstitial lung disease
Scientific Title:Acronym Neuromuscular electrical stimulation in ILD
Region
Japan

Condition
Condition interstitial lung disease (ILD)
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of neuromuscular electricalstimulation (NMES) on quadriceps muscle strength, dyspnea, exercise tolerance, activities of daily living (ADL) and health related quality of life (HRQL) in moderate to severe ILD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quadriceps muscle force
mMRC dyspnea scale
6-min walk distance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 intervention group: transcutaneous NMES of the bilateral quadriceps (five times a week, 30 minutes each session, for 12 continuous weeks)
Interventions/Control_2 control group: usual care
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients with moderate to severe ILD (MRC grade 3, 4, 5)
2. clinically stable for at least 4 weeks
Key exclusion criteria 1. severe orthopedic or neurological disorders
2. unstable cardiac disease
3. weak skin
4. malignancy
5. pregnant
6. inability to understand to use EMS equipment
7. inability to complete questionnaires
Target sample size 54

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Email mstshnd@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Masatoshi
Middle name
Last name Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email mstshnd@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Clinical Research Review Board in Nagasaki University
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7905
Email gaibushikin@ml.nagasaki-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
2020 Year 05 Month 15 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 10 Day
Last follow-up date
2022 Year 12 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
2020 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046116

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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