UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054977 |
|---|---|
| Receipt number | R000062820 |
| Scientific Title | Retrospective observational study of the efficacy threshold of exercise therapy on lipid profile in hyper LDL cholesterolemia |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/07/16 15:13:54 |
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Basic information
Public title
An Observational Study of the Lipid Profile of Exercise Therapy in Hyper LDL Cholesterolemia
Acronym
Observational Study of Hyper LDL Cholesterolemia in Exercise Therapy
Scientific Title
Retrospective observational study of the efficacy threshold of exercise therapy on lipid profile in hyper LDL cholesterolemia
Scientific Title:Acronym
Retrospective observational study of exercise therapy in hyper LDL cholesterolemia
Region
| Japan |
Condition
Condition
hyper LDL cholesterolemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect statistics on the amount of exercise and weight loss outcomes such as lipid profile/body fat percentage/abdominal circumference at the fitness center to validate the effectiveness threshold of exercise therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise intensity
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Aged 18 years and older
-Patients diagnosed with hyperlDL cholesterolemia (LDL>140 (formula F))
-Patients who have been attending the fitness center continuously for at least 1 month
Key exclusion criteria
Patients who have discontinued exercise therapy at a fitness center within one month
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL
0789361101
maru-tkb@umin.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Ishimaru |
Organization
Akashi Medical Center
Division name
Department of General Internal Medicine
Zip code
6740063
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL
0789361101
Homepage URL
maru-tkb@umin.ac.jp
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Akashi Medical Center
Address
743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel
0789361101
maru-tkb@umin.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
| 2024 | Year | 07 | Month | 16 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Race, age, gender, height, weight, BMI, abdominal circumference, body fat percentage, blood pressure, pulse and blood test data (LDL-C, HDL-C, TG, HbA1c) will be investigated in the electronic medical record. In addition, exercise date and time, exercise duration, and exercise intensity (METs) will be collected from fitness center information.
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
