UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027711 |
|---|---|
| Receipt number | R000031744 |
| Scientific Title | Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2022/01/20 11:20:26 |
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Basic information
Public title
Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Acronym
Exercise and arterial functions in obesity
Scientific Title
Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Scientific Title:Acronym
Exercise and arterial functions in obesity
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
[Before and after the 12-week intervention]
- Arterial functions (central hemodynamics)
Key secondary outcomes
[Before and after the 12-week intervention]
- Insulin sensitivity
- Glucose tolerance
- Amino acids metabolism
- Intramyocellular lipids
- Extramyocellular lipids
- Visceral fat area
- Subcutaneous fat area
- Body mass/composition
- Bone strength
- Circulating factors (e.g., cytokines)
- Male sexual function
- Peak oxygen uptake
- Cognitive function
- Sedentary behavior
- Urinary biomarkers
[Baseline and week 11-12]
- Physical activity
- Sleep habits
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: aerobic exercise training (moderate intensity, 40-60 min per session, 3 sessions per week, 12 weeks)
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
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
BMI range: 25.0-34.9 kg/m2
Key exclusion criteria
history of heart disease
history of stroke
Participation in an exercise program in the past year
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Maeda |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-8859
maeda@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kanae |
| Middle name | |
| Last name | Myoenzono |
Organization
University of Tsukuba
Division name
Doctoral Program in Sports Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-5990
Homepage URL
s1730400@s.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Ethics committee university of tsukuba
Address
Tennodai, 1-1-1, Tsukuba, Ibaraki
Tel
029-853-2571
hitorinnri@un.tsukuba.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
筑波大学総合研究棟D
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31392903/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31392903/
Number of participants that the trial has enrolled
21
Results
After the exercise intervention, weight, BMI, total body fat, abdominal visceral fat area, heart rate, and triglyceride were significantly decreased, and VO2peak was significantly elevated after the intervention. There were no significant differences in SBP, DBP, total cholesterol, HDL cholesterol, LDL cholesterol, and energy intake before and after the intervention. Moreover, there were no significant changes in baPWV,beta-stiffness index, and IMCL and EMCL contents after the exercise intervention.
Results date posted
| 2022 | Year | 01 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
21 overweight and obese men
This study included 2 current smokers, and 7 subjects were taking anti-hypertensive, anti-diabetic, or anti-hyperlipidemic medication.
Participant flow
all subjects participated aerobic exercise training program
Adverse events
Non
Outcome measures
Body weight
height
visceral fat
VO2peak
resting arterial blood pressure
resting HR
blood biochemistry
baPWV
beta-stiffness index
IMCL
EMCL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031744
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