UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027939 |
|---|---|
| Receipt number | 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 | 2025/02/26 12:56:01 |
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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 | Naoyuki |
| Middle name | |
| Last name | Hasebe |
Organization
Asahikawa Medical University
Division name
Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2442
haselove@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Nakagawa |
Organization
Asahikawa Medical University
Division name
Division of Cardiology, Nephrology, Pulmonology and Neurology, Department of Internal Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2442
Homepage URL
naka-nao@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
Asahikawa Medical University
Address
2-1-1-1 Midorigaoka higashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2297
rs-kk.g@asahikawa-med.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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/nu16244264
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It took time to analyze and publish the paper.
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032003
