UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Phase II cardic rehabilitation on cardio-renal function and physio-psychological function in elderly cardiac patients over 75 years old
Acronym	Effects of Phase II cardic rehabilitation on cardio-renal function and other functions in elderly cardiac patients
Scientific Title	Effects of Phase II cardic rehabilitation on cardio-renal function and physio-psychological function in elderly cardiac patients over 75 years old
Scientific Title:Acronym	Effects of Phase II cardic rehabilitation on cardio-renal function and other functions in elderly cardiac patients
Region	Japan

Condition
Condition	cardiac diseases
Classification by specialty	Cardiology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate the effects of outpatient phase II cardiac rehabilitation on cardio-renal function and physical-psychological function in the elderly patients with cardiac diseases over 75 years old
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical fitness renal function
Key secondary outcomes	Hospital Anxiety and Depression Scale Patient Health Questionnaire-9:PHQ-9

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	0ver 75 years old cardiac rehabilitation participation
Interventions/Control_2	0ver 75 years old cardiac rehabilitation no-participation
Interventions/Control_3	less than 75 years old cardiac rehabilitation participation
Interventions/Control_4	less than 75 years old cardiac rehabilitation no-participation
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	110 years-old >
Gender	Male and Female
Key inclusion criteria	1)cardiac patients admitted in Ota Nishinouchi Hospital 2)with informed consent
Key exclusion criteria	1)hemodyalisis 2)Activity of daily living is not independent 3)apparant dementia
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kohzuki
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8574
Address	1-1, Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-7351
Email	kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yuichiro Middle name Last name Sasamoto
Organization	Tohoku University
Division name	Graduate School of Medicine
Zip code	980-8574
Address	1-1, Seiryo-cho, Aoba-ku, Sendai
TEL	090-9032-4202
Homepage URL
Email	ssmty@globe.ocn.jp

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

Funding Source
Organization	Department of Internal Medicine and Rehabilitation Science, Tohoku Univeristy Graduate School of Medicine
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	Ethics Committees of Tohoku University School of Medicine
Address	1-1, Seiryo-cho, Aoba-ku, Sendai
Tel	022-717-8006
Email	med-kenkyo@grp.tohoku.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	2016 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/circj/85/5/85_CJ-20-0970/_article/-char/en
Number of participants that the trial has enrolled	136
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	2016 Year 04 Month 14 Day
Date of IRB	2016 Year 03 Month 28 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2021 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	2016 Year 04 Month 29 Day
Last modified on	2021 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025269