UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018582 |
|---|---|
| Receipt number | R000021507 |
| Scientific Title | Effectiveness of attraction of facility in combined aerobic and resistance training circuit on health-related physical fitness and moderation in healthcare cost among community-dwelling people |
| Date of disclosure of the study information | 2015/08/28 |
| Last modified on | 2021/02/09 11:57:44 |
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Basic information
Public title
Effectiveness of attraction of facility in combined aerobic and resistance training circuit on health-related physical fitness and moderation in healthcare cost among community-dwelling people
Acronym
Effectiveness of combined aerobic and resistance training circuit
Scientific Title
Effectiveness of attraction of facility in combined aerobic and resistance training circuit on health-related physical fitness and moderation in healthcare cost among community-dwelling people
Scientific Title:Acronym
Effectiveness of combined aerobic and resistance training circuit
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Medicine in general | Cardiology | Surgery in general |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prevention of lifestyle-related diseases and moderation in healthcare cost
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
health-related physical fitness
blood pressure
blood glucose level
blood lipid
Key secondary outcomes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
combined aerobic and resistance training circuit
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
keep training once more a week at triennium
Key exclusion criteria
disorder of locomotory apparatus
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kato |
Organization
Tottori university
Division name
faculty of medicine
Zip code
683-8503
Address
Nishimachi86 Yonago Tottori
TEL
0857-31-5662
katokun@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kato |
Organization
Tottori University
Division name
faculty of medicine
Zip code
683-8503
Address
Nishimachi86 Yonago Tottori
TEL
0857-31-5662
Homepage URL
katokun@med.tottori-u.ac.jp
Sponsor or person
Institute
Totttori University
Institute
Department
Personal name
Funding Source
Organization
Curves Japan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Science in Sports and Exercise, Tottori University
Address
Yonago, 683-8503, Japan
Tel
0857-31-5662
katokun@tottori-u.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
鳥取県大山町保健センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
https://mol.medicalonline.jp/library/archive/search?jo=eb3yonai&ye=2020&vo=71&issue=1%2F3&UserID=160
Publication of results
Unpublished
Result
URL related to results and publications
https://mol.medicalonline.jp/library/archive/search?jo=eb3yonai&ye=2020&vo=71&issue=1%2F3&UserID=160
Number of participants that the trial has enrolled
80
Results
Subjects daily lifestyle habit, body composition, physical capacity, medical examination, and cost of medical care were examined closely each year. In the subjects, the physical function improved from training after a year and they maintained a high-level result from training for four years. The improved control of hypertension, hyperlipidemia and hyperglycemia were also observed. The cost of medical care of the subjects decreased an average of 11% over the four years period.
Results date posted
| 2021 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 20 | Day |
Baseline Characteristics
162 subjects recruited from the local community
Participant flow
80 subjects met the inclusion criteria.
Adverse events
nothing
Outcome measures
lifestyle habit, body composition, physical capacity, medical examination, and cost of medical care
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021507
