UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056660 |
|---|---|
| Receipt number | R000064752 |
| Scientific Title | Enhancing physical fitness in older adults: A six-month medium intensity training intervention yields significant improvements |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/08 10:19:31 |
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Basic information
Public title
Enhancing physical fitness in older adults: A six-month medium intensity training intervention yields significant improvements
Acronym
EPFIOA:ASMMITYSI
Scientific Title
Enhancing physical fitness in older adults: A six-month medium intensity training intervention yields significant improvements
Scientific Title:Acronym
EPFIOA:ASMMITYSI
Region
| Asia(except Japan) |
Condition
Condition
Older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study involved a total of 72 participants, comprising 33 women and 39 men, aged between 60 and 70 years
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The research was carried out over a six-month period, from May to November 2022.
The Senior Fitness Test (SFT) comprises six targeted tests, each designed to measure an essential aspect of physical fitness. These tests include the 30-second Chair Stand Test (CST) to assess lower body strength, the 30-second Arm Curl Test (ACT) to evaluate upper body strength, the Chair Sit-and-Reach Test (CSRT) for flexibility, the Back Scratch Test (BST) to measure upper body flexibility, the 8-Foot Up-and-Go Test (FUG) to assess agility and dynamic balance, and the 6-Minute Walk Test (6MWT) to gauge cardiovascular endurance. Each of these six tests within the SFT provides reliable and relevant data on the different dimensions of physical fitness in older adults, making it a valuable instrument for research on aging and physical fitness interventions
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
Self control
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
6 month 3 times a week
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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) the ability to communicate effectively; (2) a willingness to engage in the intervention program upon providing informed consent; and (3) the ability to ambulate without external assistance. Conversely, exclusion criteria included
Key exclusion criteria
(1) self-reported chronic diseases or mental health conditions, such as severe cardiovascular or pulmonary diseases, musculoskeletal disorders, or major depressive episodes; (2) sensory impairments, including significant visual or auditory deficits; (3) any recent fractures or surgeries involving the hip or vertebrae within the past two months; and (4) an inability to walk independently for distances exceeding 10 meters
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | RAHMAT |
| Middle name | HIDAYAT |
| Last name | ROHIM |
Organization
WUHAN SPORTS UNIVERSITY
Division name
Department of Physical Education and Sports Coach
Zip code
430079
Address
Luoyu Road, Hongshan, Wuhan, Hubei
TEL
08687196016
rahmamatt@gmail.com
Public contact
Name of contact person
| 1st name | RAHMAT |
| Middle name | HIDAYAT |
| Last name | ROHIM |
Organization
WUHAN SPORTS UNIVERSITY
Division name
Department of Physical Education and Sports Coach
Zip code
430079
Address
Luoyu Road, Hongshan, Wuhan, Hubei
TEL
08687196016
Homepage URL
rahmamatt@gmail.com
Sponsor or person
Institute
WUHAN SPORTS UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
WUHAN SPORTS UNIVERSITY
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
WUHAN SPORTS UNIVERSITY
Address
Luoyu Road, Hongshan, Wuhan, Hubei
Tel
+86-(027) 87196016
wsuadmission@outlook.com
Secondary IDs
Secondary IDs
NO
Study ID_1
0
Org. issuing International ID_1
0
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405
Publication of results
Unpublished
Result
URL related to results and publications
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405
Number of participants that the trial has enrolled
72
Results
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405776896635049&rtpof=true&sd=true
Results date posted
| 2025 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405776896635049&rtpof=true&sd=true
Participant flow
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405776896635049&rtpof=true&sd=true
Adverse events
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405776896635049&rtpof=true&sd=true
Outcome measures
https://docs.google.com/document/d/18RGrYGi2hERKZLVdoiH93NWeFMDbcClt/edit?usp=sharing&ouid=106889405776896635049&rtpof=true&sd=true
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | 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 | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064752
