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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006374
Receipt No. R000007043
Scientific Title Relationship between physical activity and psychosocial factors in patients with implantable cardioverter-defibrillator (ICD) or implantable cardioverter-defibrillator with biventricular pacing capability (CRT-D).
Date of disclosure of the study information 2011/09/22
Last modified on 2013/10/12

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Basic information
Public title Relationship between physical activity and psychosocial factors in patients with implantable cardioverter-defibrillator (ICD) or implantable cardioverter-defibrillator with biventricular pacing capability (CRT-D).
Acronym Relationship between physical activity and psychosocial factors in patients with implantable cardioverter-defibrillator (ICD) or implantable cardioverter-defibrillator with biventricular pacing capability (CRT-D).
Scientific Title Relationship between physical activity and psychosocial factors in patients with implantable cardioverter-defibrillator (ICD) or implantable cardioverter-defibrillator with biventricular pacing capability (CRT-D).
Scientific Title:Acronym Relationship between physical activity and psychosocial factors in patients with implantable cardioverter-defibrillator (ICD) or implantable cardioverter-defibrillator with biventricular pacing capability (CRT-D).
Region
Japan

Condition
Condition ventricular arrhythmias
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the relationship between physical activity in daily life in the presence or absence of ventricular arrhythmias treated with ICD/CRT-D, and to evaluate the relationship between physical activity and psychosocial factors.
Basic objectives2 Others
Basic objectives -Others Ventricular arrhythmias with treatment, physical activity, psychosocial factors assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ICD/CRT-D therapy
Amount of physical exertion in daily life recorded by pedometer with accelerometer
SAS, SF-36, STAI, SDS
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients go to Mito Saiseikai General Hospital regularly for check of ICD or go to department of cardiovascular medicine, and written informed consent to the study.
Key exclusion criteria Who were hospitalized during the study period, who worsened symptoms in some diseases, who were deemed unsuitable by the attending physician to participate in this study, severe dementia, who had a possibility of pregnancy and pregnancy.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mori Nobuyoshi
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal Medicine and Rehabilitation Science
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7353
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal Medicine and Rehabilitation Science
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7353
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 22 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
2011 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information case-control study

Management information
Registered date
2011 Year 09 Month 20 Day
Last modified on
2013 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007043

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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