UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006374 |
|---|---|
| Receipt number | 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 18:29:39 |
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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
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
Sponsor or person
Institute
Department of Internal Medicine and Rehabilitation Science, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007043
