UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, randomized controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with interstitial lung disease
Acronym	Electrical muscle stimulation in ILD
Scientific Title	A prospective, randomized controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with interstitial lung disease
Scientific Title:Acronym	Electrical muscle 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 electrical muscle stimulation (EMS) 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	isometric quadriceps force MRC dyspnea scale 6-min walk distance
Key secondary outcomes	ADL score St. George's Respiratory Questionnaire (SGRQ)

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 Maneuver
Interventions/Control_1	intervention group: transcutaneous EMS 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	40

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

Public contact
Name of contact person	1st name Middle name Last name Masatoshi Hanada
Organization	Nagasaki University Hospital
Division name	Rehabilitation Medicine
Zip code
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 14 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	2010 Year 07 Month 08 Day
Date of IRB	2010 Year 04 Month 02 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry	2012 Year 09 Month 01 Day
Date trial data considered complete	2012 Year 09 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 08 Month 14 Day
Last modified on	2019 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004869