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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040036
Receipt No. R000045647
Scientific Title The relationship between occupational therapy participation and frailty in patients with cardiac implantable electrical device
Date of disclosure of the study information 2020/04/02
Last modified on 2020/04/02

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Basic information
Public title The relationship between occupational performance and frailty in patients with cardiac implantable electrical device
Acronym Occupational performance and frailty in patients with cardiac implantable electrical device
Scientific Title The relationship between occupational therapy participation and frailty in patients with cardiac implantable electrical device
Scientific Title:Acronym Occupational therapy participation and frailty in patients with cardiac implantable electrical device
Region
Japan

Condition
Condition Patients with cardiac implantable electrical device
Classification by specialty
Cardiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between occupational performance, frailty (physical, cognitive and social) and health related QOL in patients with cardiac implantable electrical device.
Basic objectives2 Others
Basic objectives -Others Occupational self assessment Version 2.1
EuroQol-5
Short Physical Performance Battery
Lubben Social Network Scale
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frailty
Key secondary outcomes Occupational performance
Health related QOL

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with pacemaker, Implantable Cardioverter Defibrillator, Cardiac
Resynchronization Therapy devices and generator replacement.
2. Patients aged 50 years or older at the time of participation in this study.
3. Peoples who had informed consent to this study.
Key exclusion criteria 1. Peoples who it is difficult to understand that question paper and contents of physical function assessment.
2. Peoples who has been certified as requiring long-term care.
3. Peoples who necessary ADL assistance.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Takeda
Organization Saitama Medical University International medical Center
Division name Rehabilitation center
Zip code 350-1298
Address Yamane, Hidaka-City, Saitama-Pref, Japan
TEL 042-984-4367
Email t_takeda@saitama-med.ac.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Takeda
Organization Saitama Medical University International medical Center
Division name Rehabilitation center
Zip code 350-1298
Address Yamane, Hidaka-City, Saitama-Pref, Japan
TEL 042-984-4367
Homepage URL
Email t_takeda@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama Medical University International medical Center
Address Yamane, Hidaka-City, Saitama-Pref, Japan
Tel 042-984-4523
Email chikens@saitama-med.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 04 Month 02 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 Open public recruiting
Date of protocol fixation
2019 Year 12 Month 03 Day
Date of IRB
2019 Year 12 Month 23 Day
Anticipated trial start date
2020 Year 04 Month 02 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the relationship between occupational performance, frailty (physical, cognitive and social) and health related QOL in patients with cardiac implantable electrical device.

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045647

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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