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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027939
Receipt No. R000032003
Scientific Title Effect of eXercise and Oral Nutritional supplement on prevention of frailty in hypertensive patients with stroke or chronic kidney diseases
Date of disclosure of the study information 2017/07/01
Last modified on 2017/12/15

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Basic information
Public title Effect of eXercise and Oral Nutritional supplement on prevention of frailty in hypertensive patients with stroke or chronic kidney diseases
Acronym Effect of eXercise and Oral Nutritional supplement on prevention of frailty in hypertensive patients (EXON)
Scientific Title Effect of eXercise and Oral Nutritional supplement on prevention of frailty in hypertensive patients with stroke or chronic kidney diseases
Scientific Title:Acronym Effect of eXercise and Oral Nutritional supplement on prevention of frailty in hypertensive patients (EXON)
Region
Japan

Condition
Condition Hypertensive patients with stroke or chronic kidney disease
Classification by specialty
Medicine in general Cardiology Nephrology
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of exercise and oral nutritional supplement on body composition in hypertensive patients with stroke or chronic kidney disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in body composition and frailty
Key secondary outcomes 1) Blood pressure (outpatient measurement at hospital visits), home blood pressure
2) Renal function
3) Motor function

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 Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Exercise-only group
Exercise(stretching and resistance) 2 per week
Periods: 3 months
Interventions/Control_2 Exercise plus oral nutritional supplement group
Exercise(stretching and resistance) and consume nutritional supplement 2 per week
Periods: 3 months
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
40 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria at institutions participating in the study
(1) Patients diagnosed with hypertension, regardless of treatment with an antihypertensive drug
(2) Male or female patients at least 40 years old and less than 85 years old
(3) Patients with stroke or patients with chronic kidney disease (dipstick proteinuria 1+ and above or eGFR 30-60 ml/min/1.73m2)
(4) Patients who have consented in writing
Key exclusion criteria Patients who meet any of the following criteria are not included in the study subjects
(1) Patients with myocardial infarction, unstable angina, or a peripheral artery disease that has developed within the last 6 months
(2) Patients with acute-phase heart failure
(3) Patients being treated for malignant tumors
(4) Patients who have undergone a surgery within the last 6 months
(5) Patients who have allergies to milk or soy
(6) Patients with severe renal dysfunction (eGFR less than 30 ml/min/1.73m2)
(7) Other patients that an investigator finds inappropriate to be included in the study population
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Hasebe
Organization Asahikawa Medical University
Division name Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
Address 2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2442
Email haselove@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Nakagawa
Organization Asahikawa Medical University
Division name Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
Address 2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2442
Homepage URL
Email naka-nao@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 06 Month 26 Day
Last modified on
2017 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032003

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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