UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034111 |
|---|---|
| Receipt number | R000038838 |
| Scientific Title | Exercise training for improvement of locomotive syndrome and arterial stiffness |
| Date of disclosure of the study information | 2018/09/13 |
| Last modified on | 2023/03/28 14:54:17 |
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Basic information
Public title
Exercise training for improvement of locomotive syndrome and arterial stiffness
Acronym
Exercise against locomotive syndrome and arterial stiffness
Scientific Title
Exercise training for improvement of locomotive syndrome and arterial stiffness
Scientific Title:Acronym
Exercise against locomotive syndrome and arterial stiffness
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a six-week training program that involves both resistance and aerobic exercises on locomotive function and arterial stiffness in middle-aged and older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Before and after the six-week intervention]
- Locomotive function
- Arterial stiffness
Key secondary outcomes
[Before and after the six-week intervention]
- Body mass/composition
- Waist circumference
- Peak oxygen uptake
- Blood chemistry parameters (e.g., glucose and lipids)
- Circulating factors (e.g., cytokines)
- Blood pressure at rest
- Acute response of blood pressure to exercise
- Maximum muscular strength
- Flexibility
[Two weeks before the intervention and during the six-week intervention]
- Physical activity energy expenditure (intensity and time)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
An intervention group: a six-week exercise program that includes a 10 min warm-up session followed by a 30 min resistance exercise and 30 min aerobic exercise session and concludes with a 5 min cool-down session. A day a week under the supervision of exercise instructors and three days a week without the supervision. The resistance exercise session basically consists of bodyweight workouts, and the intensity and repetition are gradually and individually increased according to the participant's fitness. The aerobic exercise session is mainly composed of a walking program that targets 60-75% of the participant's age-predicted maximal heart rate.
Interventions/Control_2
A control group: maintenance of usual lifestyle.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-
Key exclusion criteria
- A history of cardiovascular disease
- Currently taking medication for hypertension
- Currently smoking
- Currently exercising (at high intensity) at least two days a week
- Difficulties in exercise
- Current participation or intention to participate in other clinical trials
- Considered ineligible judged by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Otsuki |
Organization
Ryutsu Keizai University
Division name
Faculty of Health and Sport Sciences
Zip code
301-8555
Address
120 Ryugasaki, Ibaraki, Japan
TEL
0297-60-1933
otsuki-takeshi@rku.ac.jp
Public contact
Name of contact person
| 1st name | Asako |
| Middle name | |
| Last name | Zempo |
Organization
Ryutsu Keizai University
Division name
Faculty of Health and Sport Sciences
Zip code
301-8555
Address
120 Ryugasaki, Ibaraki, Japan
TEL
0297-60-1966
Homepage URL
zempo@rku.ac.jp
Sponsor or person
Institute
Ryutsu Keizai University
Institute
Department
Personal name
Funding Source
Organization
Ryutsu Keizai University
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
The Research Ethics Committee of Ryutsu Keizai University
Address
120 Ryugasaki, Ibaraki, Japan
Tel
0297-64-0001
soumu@rku.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
| 2018 | 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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038838
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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