UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052203 |
|---|---|
| Receipt number | R000059575 |
| Scientific Title | Effects of increased physical activity on physical function and cardiovascular disease risk in middle-aged and older adults |
| Date of disclosure of the study information | 2023/09/13 |
| Last modified on | 2023/09/13 20:56:37 |
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Basic information
Public title
Effects of increased physical activity on physical function and cardiovascular disease risk in middle-aged and older adults
Acronym
Effects of increased physical activity on physical function and cardiovascular disease risk in middle-aged and older adults
Scientific Title
Effects of increased physical activity on physical function and cardiovascular disease risk in middle-aged and older adults
Scientific Title:Acronym
Effects of increased physical activity on physical function and cardiovascular disease risk in middle-aged and older adults
Region
| Japan |
Condition
Condition
middle-aged and older adults
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of physical activity on physical function and cardiovascular disease risk in middle-aged and older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of 12-week increased physical activity on physical function (muscle strength and function and endurance capacity) and cardiovascular disease risk in middle-aged and older adults.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Non-intervention control
Interventions/Control_2
Continuous medium-intensity physical activity in addition to daily life
Interventions/Control_3
Increases physical activity in addition to daily life
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who do not meet the exclusion criteria
Key exclusion criteria
1) Patients with obesity due to adrenal diseases
2) Patients with cardiovascular diseases
3) Patients with hepatic dysfunction
4) Patients with renal dysfunction (serum creatinine level: 3.0mg/dl or higher)
5) Patients with antidiabetic drugs, Ca channel blockers, beta blockers, and drugs that affect heart rate
6) Patients with limited exercise therapy
7) Subjects who can not swallow supplement
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | none |
| Last name | Iemitsu |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL
0775613760
iemitsu@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Motoyuki |
| Middle name | none |
| Last name | Iemitsu |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL
0775994131
Homepage URL
iemitsu@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
0775613412
b-rinri@st.ritsumei.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
| 2023 | Year | 09 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | 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
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059575
