UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060187 |
|---|---|
| Receipt number | R000068838 |
| Scientific Title | Effect of 12-Week Unstable Surfaces Resistance Training on Muscle Stiffness, Muscle Co-Activation, and Balance in Older Individuals |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/23 23:36:55 |
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Basic information
Public title
How 12 Weeks of Balance-Based Resistance Training Affects Muscle and Balance in Older Adults
Acronym
URT-Balance
Scientific Title
Effect of 12-Week Unstable Surfaces Resistance Training on Muscle Stiffness, Muscle Co-Activation, and Balance in Older Individuals
Scientific Title:Acronym
Effect of 12-Week Unstable Surfaces Resistance Training on Muscle Stiffness, Muscle Co-Activation, and Balance in Older Individuals (URT-Balance)
Region
| Asia(except Japan) |
Condition
Condition
Age-related balance impairment and muscle dysfunction in older adults
Classification by specialty
| Geriatrics | Rehabilitation medicine | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the effects of a 12-week unstable surfaces resistance training (URT) program compared to stable resistance training (SRT) on muscle stiffness, muscle co-activation, and balance performance in older adults. This study aims to determine whether URT can improve neuromuscular efficiency, reduce joint pain, and enhance balance, thereby reducing fall risk and supporting functional independence in the elderly population.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change in static balance assessed by Balance Error Scoring System (BESS) at baseline and after 12 weeks.
2. Change in dynamic balance assessed by Y-Balance Test (YBT) at baseline and after 12 weeks.
Key secondary outcomes
1. Change in muscle stiffness (quadriceps and hamstrings), measured by shear wave elastography (SWE) at baseline and after 12 weeks.
2. Change in knee pain intensity, measured using Visual Analogue Scale (VAS) at baseline and after 12 weeks.
3.Change in lower-limb muscle co-activation during squat movements (squat-down, stand-up, and transition phases), measured by surface EMG at baseline and after 12 weeks of intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Unstable Resistance Training (URT): Participants performed lower-limb instability resistance training for 12 weeks (3 sessions per week). Each session included warm-up, main training, and cool-down. The training involved exercises like squats, lunges, and step-ups performed on unstable surfaces (e.g., balance pads). The intensity and duration were progressively increased and matched with the control group.
Interventions/Control_2
Standard Resistance Training (SRT): Participants performed traditional lower-limb resistance training for 12 weeks (3 sessions per week). Exercises included bodyweight or resistance band squats, lunges, and step-ups on stable surfaces. The intensity and total training volume were matched to the URT group to ensure comparability.
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
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged between 65 and 75 years.
Able to walk independently on level ground and up/down stairs with normal joint function (flexion and extension).
No history of hip, knee, or ankle pain, surgery, or trauma in the last six months.
Willing to voluntarily participate and sign the informed consent form.
Key exclusion criteria
Presence of any severe neuromusculoskeletal injuries or diseases.
Diagnosed with serious cardiovascular, cerebrovascular diseases, or mental disorders.
Inability to perform or cooperate with the required physical tasks.
Known allergy to surface electrodes.
Any other severe medical conditions or reasons that may prevent completion of the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ping |
| Middle name | |
| Last name | Liu |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Universiti Malaya, 50603 Kuala Lumpur, Malaysia
TEL
+8613639443653
liu2578794@gmail.com
Public contact
Name of contact person
| 1st name | Ping |
| Middle name | |
| Last name | Liu |
Organization
Universiti Malaya
Division name
Faculty of Sports and Exercise Science
Zip code
50603
Address
Universiti Malaya, 50603 Kuala Lumpur, Malaysia
TEL
+8613639443653
Homepage URL
liu2578794@gmail.com
Sponsor or person
Institute
None.
Institute
Department
Personal name
Ping Liu
Funding Source
Organization
None.
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
Ethics Committee, Qufu Normal University
Address
No. 57 Jingxuan West Road, Qufu City, Shandong, China
Tel
+8613639443653
yangyuewei@163.com
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 | 12 | Month | 23 | 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
50
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | 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 | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068838
