UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053790 |
|---|---|
| Receipt number | R000061375 |
| Scientific Title | the effects of local exercise for peripheral circulation measured by the microscope |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/09/05 21:40:27 |
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Basic information
Public title
the effects of local exercise for peripheral circulation measured by the microscope
Acronym
the effects of local exercise for peripheral circulation
Scientific Title
the effects of local exercise for peripheral circulation measured by the microscope
Scientific Title:Acronym
the effects of local exercise for peripheral circulation
Region
| Japan |
Condition
Condition
community dwelling elderly
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Nephrology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of local exercise for peripheral circulation measured by the microscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Capillary diameter, capillary blood velocity
Key secondary outcomes
Association between ABI, CAVI, blood pressure, body composition, bone density, physical activities and capillary indexes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The participant performs a 1-minute arm curl (expansion and contraction of the elbow) in 13RPE and measures a capillary index. Before participants performed a 1-minute arm curl, they are measured ABI,CAVI,blood pressure,body composition,bone density, physical activities. The turn of the examination is carried out at random.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
community dwelling elderly who have no regular exercise habits with a hypertensive symptom
Key exclusion criteria
Cardiac patients of the acute phase within 7 days, Unstable angina and other medical conditions who situated no under controlled
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Miura |
Organization
Tsukuba University of Technology
Division name
Division of Health Sciences
Zip code
305-8521
Address
4-12-7,Kasuga,Ibaraki,305-8521
TEL
0298589552
m.miura@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Miura |
Organization
Tsukuba University of Technology
Division name
Division of Heath Sciences
Zip code
305-8521
Address
4-12-7,Kasuga,Ibaraki,305-8521
TEL
0298589552
Homepage URL
m.miura@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
MISA MIURA
Funding Source
Organization
Tsukuba University of Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Tsukuba University of Technology
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4-12-7,Kasuga,Ibaraki,305-8521
Tel
0298589552
m.miura@k.tsukuba-tech.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
筑波技術大学保健科学部
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11122561
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11122561
Number of participants that the trial has enrolled
20
Results
There were 20 participants with a mean (SD) age of 67.1 (5.8) years. The capillary flow rate significantly changed, and the capillary density significantly changed, which included a significant increase in the non-exercising limb. Significant correlations were observed between the nailfold capillary diameter and body fat mass, the capillary diameter and physical activity, and the capillary density and bone mineral density.
Results date posted
| 2024 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 10 | Day |
Baseline Characteristics
Inclusion criteria are as follows:
Community-dwelling elderly individuals aged 60 or older who do not have a regular exercise habit
Individuals who meet the criteria for hypertension at the time of measurement
Individuals who have been informed about the study and have given their consent to participate
Exclusion criteria are as follows:
Patients with a systolic blood pressure of 180 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher
Individuals requiring acute treatment for acute coronary syndrome, unstable angina, or other conditions
Individuals deemed ineligible for the study by the investigator for other reasons and those with contraindications to exercise therapy as outlined in the American College of Sports Medicine's "Guidelines for Exercise Testing and Prescription" (9th edition)
Participant flow
This study enrolled community-dwelling elderly individuals with hypertension who attended public facilities in Tsukuba City, Japan, between December 2022 and January 2024 (Figure 1). Of the 23 eligible participants, 20 provided informed consent.
Adverse events
All participants completed the experiments without any difficulty or side effects.
Outcome measures
We measured the acute effects of reperfusion on nailfold density, flow, and diameters. Secondary outcomes included the correlations between microvascular parameters and other health-related indicators.
Plan to share IPD
Data is provided within the manuscript or suplemental files.
IPD sharing Plan description
Data is provided within the manuscript or suplemental files. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11122561/
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061375
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/09/06 | 研究計画書＿マイクロスコープ.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/09/06 | submit datum20240417.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/09/06 | submit datum20240417.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/61375
