UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042135 |
|---|---|
| Receipt number | R000048093 |
| Scientific Title | A pilot study on evaluation of physical activity, cardiac function, and autonomic nervous function of patients with muscle diseases using wearable devices |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2021/04/18 16:24:59 |
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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
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/
anakamu@shinshu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Matsumoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048093
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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