UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057905 |
|---|---|
| Receipt number | R000066192 |
| Scientific Title | Development of a Physical Fitness Maintenance and Improvement Program for Older Firefighters in the Sakado-Tsurugashima Fire Department: A Pre-Post Intervention Study |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/19 16:23:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a Physical Fitness Maintenance and Improvement Program for Older Firefighters in the Sakado-Tsurugashima Fire Department: A Pre-Post Intervention Study
Acronym
Intervention Effects of a Fitness Program for Older Firefighters in Sakado-Tsurugashima
Scientific Title
Development of a Physical Fitness Maintenance and Improvement Program for Older Firefighters in the Sakado-Tsurugashima Fire Department: A Pre-Post Intervention Study
Scientific Title:Acronym
Intervention Effects of a Fitness Program for Older Firefighters in Sakado-Tsurugashima
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a physical fitness maintenance and improvement program for older firefighters in the fire department union and to examine its effectiveness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness indicators (standing long jump, 20-meter shuttle run, and side-to-side jumps)
Key secondary outcomes
Physical fitness indicators: height, weight, BMI, sit-ups, grip strength, sit-and-reach, Thomas test, and straight leg raise (SLR) test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
To implement a physical fitness maintenance and improvement program for older employees.
Interventions/Control_2
Not implementing a physical fitness maintenance and improvement program for older employees
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Headquarters staff of the Sakado-Tsurugashima Fire Department Union
2)Individuals who are capable of undergoing and participating in physical and fitness assessments
3)Individuals who have received a thorough explanation of the study, fully understood its contents, and provided written informed consent of their own free will
Key exclusion criteria
1)If the participant requests to withdraw from the study
2)If the study is interrupted due to the participant personal circumstances
3)If an unexpected incident or accident occurs
4)If abnormal vital signs are observed prior to the self-exercise session, specifically systolic blood pressure 180 mmHg, diastolic blood pressure 110 mmHg, or heart rate 100 beats per minute
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kudo |
Organization
Nihon Institute of Medical Science
Division name
Physical Therapy Course , Department of Rehabilitation, Faculty of Health Sciences
Zip code
350-0435
Address
1276 Shimogawara, Moroyama-machi, Iruma-gun, Saitama
TEL
049-294-9000
kudo@nims.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kudo |
Organization
Nihon Institute of Medical Science
Division name
Physical Therapy Course , Department of Rehabilitation, Faculty of Health Sciences
Zip code
350-0435
Address
1276 Shimogawara, Moroyama-machi, Iruma-gun, Saitama
TEL
049-294-9000
Homepage URL
kudo@nims.ac.jp
Sponsor or person
Institute
Nihon Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Nihon Institute of Medical Science
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
Research and Ethics Committee, Nippon Institute of Medical Science
Address
1276 Shimogawara, Moroyama-machi, Iruma-gun, Saitama
Tel
049-294-9000
researchethics@nims.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
日本医療科学大学（埼玉県）、城西大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066192
