UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study on evaluation of physical activity, cardiac function, and autonomic nervous function of patients with muscle diseases using wearable devices
Acronym	Evaluation of physical and biological activities of patients with muscle diseases using wearable devices
Scientific Title	A pilot study on evaluation of physical activity, cardiac function, and autonomic nervous function of patients with muscle diseases using wearable devices
Scientific Title:Acronym	Evaluation of physical and biological activities of patients with muscle diseases using wearable devices
Region	Japan

Condition
Condition	Duchenne and Becker muscular dystrophy
Classification by specialty	Neurology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to collect information useful for the natural history and timing of intervention, to determine the efficacy of the therapeutic agents or investigational drug, and to examine its safety of long-term measurement of physical activity, cardiac function, and autonomic nervous function, in patients with muscular dystrophy using a wearable device multifunctional wireless Holter recorder.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	physical activity data
Key secondary outcomes	ECG data and autonomic nervous activity (heart rate variability HRV) data

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	A wearable device will be attached to walkable pediatric or adult patients (10 patients) to measure 3-axis acceleration data, electrocardiographic data, and surface temperature data. Continuous measurement (1 course) for 3 days per patient, and 2 courses will be carried out.
Interventions/Control_2
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	5 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	1) Patients diagnosed with Duchenne or Becker muscular dystrophy (with or without genetic diagnosis) 2) Patients who can walk (350 m or more after walking for 6 minutes) 3) Patients who do not develop heart failure and respiratory failure (including not wearing a ventilator) 4) Patients who can visit the research institution on a regular basis 5) Patients who have obtained consent for this study, or patients who have obtained the consent of a substitute if they do not have the ability to consent.
Key exclusion criteria	1) Patients not diagnosed with Duchenne or Becker muscular dystrophy 2) If you cannot walk (less than 350m after walking for 6 minutes) 3) Patients with both heart failure and respiratory failure 4) Patients who have difficulty visiting the research institution on a regular basis 5) Patients who do not consent to this study
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akinori Middle name Last name Nakamura
Organization	National Hospital Organization Matsumoto Medical Center
Division name	Department of Clinical Research
Zip code	399-8701
Address	2-20-30 Muraimachi-minam, Matsumoto, Nagano
TEL	0263-58-4567
Email	anakamu@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Akinori Middle name Last name Nakamura
Organization	National Hospital Organization Matsumoto Medical Center
Division name	Department of Clinical Research
Zip code	399-8701
Address	2-20-30 Muraimachi-minam, Matsumoto, Nagano
TEL	0263-58-4567
Homepage URL	https://mmccenta.jp/sinryoka/rinshokenkyubu/
Email	anakamu@shinshu-u.ac.jp

Sponsor
Institute	National Hospital Organization Matsumoto Medical Center
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Hospital Organization Matsumoto Medical Center
Address	2-20-30 Muraimachi-minam, Matsumoto, Nagano
Tel	0263-58-4567
Email	takagi.yoshiyuki.fv@mail.hosp.go.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	国立病院機構大阪刀根山医療センター（大阪府）、国立病院機構鈴鹿病院（三重県）、兵庫医科大学病院（兵庫県）、日本筋ジストロフィー協会（東京都）、武田薬品工業株式会社（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 19 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	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 10 Day
Date of IRB	2020 Year 09 Month 23 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2022 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	2020 Year 10 Month 16 Day
Last modified on	2021 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048093