UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047490 |
|---|---|
| Receipt number | R000054155 |
| Scientific Title | A pilot study to clarify the effects of exercise therapy in medical fitness clubs |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2023/12/05 18:32:09 |
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Basic information
Public title
A pilot study to clarify the effects of exercise therapy in medical fitness clubs
Acronym
Verification of structured exercise programs in medical fitness clubs
Scientific Title
A pilot study to clarify the effects of exercise therapy in medical fitness clubs
Scientific Title:Acronym
Verification of structured exercise programs in medical fitness clubs
Region
| Japan |
Condition
Condition
lifestyle-related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of implementing exercise therapy in medical 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
Medical cost of lifestyle-related diseases
Key secondary outcomes
- Body Mass Index
- 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
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
Implementation of structured exercise programs in medical fitness clubs for 6 months
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Males and females aged 40 to 64 years old
- Person who is taking medicine for lifestyle-related diseases
- Informed consent
- Person who are recommended to perform exercise therapy by physician
Key exclusion criteria
- Person who used fitness clubs within 10 months before the start of this study
- Person who belong to the medical fitness clubs (to eliminate the possibility of influencing the study results)
Target sample size
30
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
| 2022 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
Results of a one-arm before-and-after comparison study showed no significant change in medical costs after a six-month intervention.
This study was unable to determine the impact of a 6-month "standard exercise program" on medical costs.
As for the other objective of this study, a feasibility study, it was confirmed that it is possible to obtain medical cost information from participants to exercise program intervention studies without major challenges.
Results date posted
| 2023 | Year | 04 | Month | 16 | Day |
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
| 2022 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 24 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 24 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054155
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