UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045228 |
|---|---|
| Receipt number | R000051665 |
| Scientific Title | A randomized controlled trial for verification of structured exercise programs in fitness clubs |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2023/09/16 09:56:37 |
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Basic information
Public title
A randomized controlled trial for verification of structured exercise programs in fitness clubs
Acronym
Verification of structured exercise programs in fitness clubs
Scientific Title
A randomized controlled trial for verification of structured exercise programs in fitness clubs
Scientific Title:Acronym
Verification of structured exercise programs in fitness clubs
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of implementing structured exercise programs in fitness clubs on health outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Body Mass Index
Key secondary outcomes
- VO2max; maximal oxygen uptake
- Waist circumference
- Muscle strength (leg strength, grip strength)
- Flexibility
- Systolic blood pressure, Diastolic blood pressure
- Glucose metabolism (Fasting blood glucose, HbA1c)
- Lipid metabolism (LDC-C, HDL-C, TG)
- Exercise frequency
- Amount of Physical activity
- Subjective happiness scale
- Self-efficacy for exercise
- Health-related QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of structured exercise programs in fitness clubs for 6 months
Interventions/Control_2
Implementation of regular health guidance
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Health checkup examinee
- Males and females aged 40 to 64 years old
- Person who classified as "Motivational Health Guidance program" or "Intensive Health Guidance program" as a result of the health checkup
- Informed consent
- Person for whom exercise is not contraindicated
Key exclusion criteria
- Person who used fitness clubs within 10 months before the start of this study
- Person who belong to the fitness clubs (to eliminate the possibility of influencing the study results)
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Sawada |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
042-947-6779
health@list.waseda.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Sawada |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
042-947-6779
Homepage URL
health@list.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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 Review Committee on Research with Human Subjects, Waseda University
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo, 169-8050, JAPAN
Tel
03-3203-4141
rinri@list.waseda.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
| 2021 | Year | 08 | Month | 25 | 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
455
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
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051665
