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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005072
Receipt No. R000006035
Scientific Title Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study
Date of disclosure of the study information 2011/03/01
Last modified on 2017/02/17

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Basic information
Public title Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study
Acronym Effects of chair exercises in elderly patients with cardiac diseases
Scientific Title Effects of chair exercises on physical function and mental health in elderly patients with cardiac diseases-A pilot study
Scientific Title:Acronym Effects of chair exercises in elderly patients with cardiac diseases
Region
Japan

Condition
Condition Elderly patients with cardiac diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and the efficacy of a chair exercise program we developed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Six-minute walk distance
Key secondary outcomes Grip strength, capacity for sense of balance, state of depression, heart rate variability, plasma brain natriuretic peptide level, serum LDL cholesterol level, serum HDL cholesterol level, and blood HbA1c level.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Chair exercises
Interventions/Control_2 Ordinary care
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients older than or equal to 65 years old who receive regular outpatient treatment at the Department of Cardiovascular Medicine, Kyoto University Hospital.
Key exclusion criteria Unstable hemodynamic status (uncontrolled hypertension, uncontrolled arrhythmia, uncontrolled congestion)
Severe aortic valve disease
Active inflammatory disease
Terminal cancer
Chronic renal failure requiring hemodialysis
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Neiko Ozasa
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Japan
TEL +81757514255
Email nei126@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Neiko Ozasa
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Kyoto, Japan
TEL +81757514255
Homepage URL
Email nei126@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization The Nakatomi Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 03 Month 01 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 Preinitiation
Date of protocol fixation
2011 Year 02 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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

Management information
Registered date
2011 Year 02 Month 13 Day
Last modified on
2017 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006035

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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