UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060197 |
|---|---|
| Receipt number | R000068852 |
| Scientific Title | Comparative Effects of 12-Week Resistance Training on Unstable and Stable Surfaces on Muscle Stiffness, Muscle Co-activation, and Balance in Older Patients with Knee Osteoarthritis |
| Date of disclosure of the study information | 2025/12/24 |
| Last modified on | 2025/12/24 22:45:17 |
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Basic information
Public title
Comparative Effects of 12-Week Resistance Training on Muscle Stiffness, Co-activation, and Balance in Older Adults with Knee Osteoarthritis
Acronym
URT vs. SRT in KOA
Scientific Title
Comparative Effects of 12-Week Resistance Training on Unstable and Stable Surfaces on Muscle Stiffness, Muscle Co-activation, and Balance in Older Patients with Knee Osteoarthritis
Scientific Title:Acronym
Comparative Effects of 12-Week Resistance Training on Unstable and Stable Surfaces on Muscle Stiffness, Muscle Co-activation, and Balance in Older Patients with Knee Osteoarthritis
Region
| Asia(except Japan) |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of a 12-week resistance training program on unstable versus stable surfaces on muscle stiffness, muscle co-activation, and balance in older adults with knee osteoarthritis. The objective is to determine which training condition is more effective in improving musculoskeletal function and postural control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle stiffness of the quadriceps and hamstring muscles measured using shear wave elastography at baseline and after 12 weeks of intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Participants in the URT group will undergo a 12 week resistance training program performed on unstable surfaces (e.g., BOSU balls or balance pads). Training will be conducted 3 times per week, each session lasting approximately 45 to 60 minutes, and includes exercises like squats, lunges, and leg extensions. Exercise intensity will progressively increase over. time. Sessions will be supervised by trained physiotherapists.
Interventions/Control_2
Participants in the SRT group will undergo the same 12-week resistance training protocol as the URT group, but on stable surfaces (e.g., gym floor or exercise mats). The frequency, duration, and exercise types are identical, but without surface instability. Sessions will also be supervised by trained physiotherapists.
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 | months-old | <= |
Age-upper limit
| 75 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged 60 years or older
Clinically diagnosed with knee osteoarthritis according to ACR criteria
Able to walk independently without assistive devices
Willing and able to participate in a 12-week resistance training program
Provided written informed consent
Key exclusion criteria
Presence of neurological disorders affecting motor function.
Severe cardiovascular or respiratory disease that contraindicates exercise.
Recent knee surgery or intra-articular injection within the past 6 months.
Participation in other structured exercise programs during the study period.
Cognitive impairment that affects ability to follow instructions.
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
shiyueyue666888@gmail.com
Sponsor or person
Institute
Qufu Normal University
Institute
Department
Personal name
Ping Liu
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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 Province
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 | 24 | 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 | 04 | 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 | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068852
