UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057971 |
|---|---|
| Receipt number | R000066276 |
| Scientific Title | Effects of Dynamic Steadiness Squat Training on Force Steadiness and Physical Function in Older Adults |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/11/24 12:22:27 |
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Basic information
Public title
Can Slow and Smooth Squats Improve Strength and Movement in Older Adults?
Acronym
The SMILE Study: Steady Movement Improving Lower-body Efficacy in Older Adults
Scientific Title
Effects of Dynamic Steadiness Squat Training on Force Steadiness and Physical Function in Older Adults
Scientific Title:Acronym
SMILE (Steady Movement Improving Lower-body Efficacy) Study
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of a dynamic steadiness squat training program on functional ability and force steadiness in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Assessment of Force Steadiness During Squatting
Force steadiness during squatting will be assessed by measuring thigh angular velocity using an inertial sensor on the thigh. Variability in angular velocity will quantify force steadiness. Lower-limb muscle activity will also be assessed using surface electromyography (EMG).
Key secondary outcomes
2. Isometric Knee Extension and Flexion Strength Testing
Isometric knee extension and flexion strength will be measured with an isokinetic dynamometer. Muscle activity during testing will also be recorded via surface EMG.
3. Assessment of Lower-Limb Proprioception
Knee joint proprioception will be assessed by quantifying the difference between perceived and actual knee joint angles using an isokinetic dynamometer. This will evaluate changes in joint position sense.
4. Chair Rise Test
Participants will perform 10 repetitions of a sit-to-stand movement from a chair with a backrest, standing completely and sitting back down. The total time will be measured.
5. Stair Climb Test
Participants will ascend and descend a four-step flight of stairs as quickly and safely as possible, without handrails. The time from start to end will be recorded.
6. Single-Leg Stance with Eyes Open
Participants will stand barefoot on a force plate with hands on hips. While lifting the non-tested leg approximately 5 cm, the duration of balance maintained on the tested leg will be measured.
7. Timed Up and Go (TUG) Test
Participants will sit in a chair with armrests, then stand, walk 3 meters at a comfortable fast pace, turn, return, and sit down. The total time from standing up to re-seating will be recorded.
8. Force Steadiness During Isometric Contraction
Force steadiness will be measured during 12-second isometric contractions at 10% and 2.5% of maximal voluntary contraction (MVC). Lower limb muscle activity will also be assessed using surface EMG.
9. Force Steadiness During Concentric and Eccentric Contraction
Seated participants will have an inertial sensor on the lower leg to measure angular velocity during knee extension and flexion. Variability in angular velocity will quantify force steadiness. Lower limb muscle activity will also be evaluated using surface EMG.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In the Dynamic Steadiness Squat Training group, a small wireless accelerometer connected to a tablet will be attached to the lateral surface of the participant's thigh. The angular velocity of the thigh will be displayed on the tablet in real time. Participants will perform bodyweight squats while viewing the real-time angular velocity displacement of their thigh on the tablet screen. During the squats, participants will be instructed to complete the downward and upward phases in 5 seconds each, and to consciously keep the variability of their thigh's angular velocity within a specified range. At home, participants will perform the same squat training as smoothly as possible, with an emphasis on minimizing unnecessary fluctuations.
Interventions/Control_2
In the Conventional Squat Training group, participants will be instructed to perform slow-paced squats at home. Each training session will consist of 3 to 5 sets of 10 repetitions.
Interventions/Control_3
To compare intervention training for Intervention 1 and Intervention 2, habitually untrained males and females in their 20s and 30s will serve as a control group and will not undergo any training.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants
The study will target community-dwelling older adults (both men and women) who are able to walk independently for at least 10 meters.
Control3
This study targets males and females in their 20s and 30s who are not habitually performing strength training.
Key exclusion criteria
Participants will be excluded from the study if they meet any of the following conditions:
1. Engaged in resistance training or high-intensity exercise within the past year.
2. Unable to commit to a training schedule of three sessions per week for eight weeks.
3. Diagnosed by a physician with a neurological or cardiovascular disease.
4. Advised by a physician to restrict physical activity for any reason.
5. Deemed by the investigators to be unsuitable for participation in the study.
Control3
1. Individuals who have been medically advised to avoid exercise, or who have injuries/disabilities that hinder exercise.
2. Individuals who habitually engage in strength training.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Shimokochi |
Organization
Osaka University of Health and Sport Sciences
Division name
School of Sport Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennangun, Osaka, 590-0496, Japan
TEL
072-453-8903
yshimoko@ouhs.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Shimokochi |
Organization
Osaka University of Health and Sport Sciences
Division name
School of Sport Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennangun, Osaka, 590-0496, Japan
TEL
072-453-8903
Homepage URL
yshimoko@ouhs.ac.jp
Sponsor or person
Institute
Osaka University of Health and Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka University of Health and Sport Sciences
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
Osaka University of Health and Sport Sciences
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka, 590-0496, Japan
Tel
072-453-7022
y-taki@ouhs.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 17 | 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 | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066276
