UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040414 |
|---|---|
| Receipt number | 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 | 2023/11/02 07:07:48 |
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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
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
mstshnd@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
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
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046116
