Muscle WeaknessNCT06565325
The Immediate Effect of Combined Terminal Knee Extension Exercise With Audible Cues
A study testing Exercise + Audible Cues and Exercise in people with Muscle Weakness, run by Mahidol University at 1 site in Thailand.
Trial summary
Typically, patients perform TKE by themselves after exercise prescription. The investigators thought that a lack of attention and preferred speed of patients might not provide the best outcome. Therefore, an increased effectiveness of TKE is interesting for physical therapy implication. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Exercise + Audible Cues and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 10 Feb 2024to 7 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged range between 18 and 30 years
- BMI of 18.5-25 kg/m2
- Male or female
- Lightly active or sedentary {Physical activity level (PAL= 1.4-1.69)}
Who cannot join
- History of serious injury or operation of lower back and lower extremities such as fracture
- Musculoskeletal problems of lower back and lower extremities in 6 months before the study
- Single-leg stance test < 43 seconds (26). and range of weight-bearing lunge test < 9.1 cm
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, Salaya, 73170
About this study
Official title: The Immediate Effect of Combined Terminal Knee Extension Exercise With Audible Cues on Vastus Medialis Muscle Motor Unit Behavior in Healthy Individuals
Typically, patients perform TKE by themselves after exercise prescription. The investigators thought that a lack of attention and preferred speed of patients might not provide the best outcome. Therefore, an increased effectiveness of TKE is interesting for physical therapy implication. Besides, adding sensory input which is audible cues or rhythm during exercise may enhance the efficacy of the exercise by increasing neuromuscular control and function.
Therefore, the study aimed to investigate the immediate effects of combined TKE with audible cues on motor unit behavior. The researchers expect that adding rhythm from the metronome will enhance neuromuscular control which may change motor unit behavior of VM muscle. The findings of the study may have helped explain the mechanism behind the acute effects of combined TKE with audible cues on VM function and their potential application in the field of physical therapy.
This study aims to investigate the immediate effect of combined TKE with audible cues on motor unit behavior in healthy participants and to investigate reliability of decomposition electromyography procedure during single leg squat.
Read the detailed description
A metronome will be used to provide rhythmic exercise. Participants will stand with their feet in line with their shoulders as starting position and straping at the knee. Exercise intensity is 60% of the 1RM weight. At the beginning of the exercise, participants will be asked to bend their knees following the pull of the resistance and exert force to straighten the knee (10 times/set and 3 sets). 180 seconds of resting will be allowed between sets.
- Conditions
- Muscle Weakness
- Being tested
- Exercise + Audible Cues, Exercise
- Keywords
- Terminal Knee Extension Exercise, Audible Cues, Therapeutic exercise, Muscle strength
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + Audible CuesBehavioural
Also called Metronome
Combined Terminal Knee Extension Exercise with Audible Cues
ExerciseBehavioural
Terminal Knee Extension Exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Terminal Knee Extension Exercise with Audible Cues Receives: Behavioral: Exercise + Audible Cues |
| Control group | Active comparator | Terminal Knee Extension Exercise without Audible Cues Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor unit firing rate
one parameter to explain the motor unit behavior of vastus medialis muscle
Measured: At the end of Cycle 1 (each cycle is 1 day)
Peak motor action potential
one parameter to explain the motor unit behavior of vastus medialis muscle
Measured: At the end of Cycle 1 (each cycle is 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Feb 2024
- Primary completion7 Feb 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups in the current study including exercise with and without audible cues.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komsak Sinsurin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565325
- Sponsor's protocol ID
- MU-CIRB 2024/021.0802
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suntornon P, Kiratisin P, Sinsurin K, Nitkotom S, Sonsukong A, Thong-On S, Watcharakeunkhan P, Sakunkaruna T. Exercise synchronized with audible cues preserves motor unit action potential: a randomized control trial study. BMC Sports Sci Med Rehabil. 2025 Dec 17;18(1):64. doi: 10.1186/s13102-025-01490-y.
PubMed 41402906
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Combined Terminal Knee Extension Exercise With Audible Cues on Vastus Medialis Muscle Motor Unit Behavior in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06565325
- Acronym / sponsor ID
- MU-CIRB 2024/021.0802
- Conditions
- Muscle Weakness
- Keywords
- Terminal Knee Extension Exercise, Audible Cues, Therapeutic exercise, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Typically, patients perform TKE by themselves after exercise prescription. The investigators thought that a lack of attention and preferred speed of patients might not provide the best outcome. Therefore, an increased effectiveness of TKE is interesting for physical therapy implication. Besides, adding sensory input which is audible cues or rhythm during exercise may enhance the efficacy of the exercise by increasing neuromuscular control and function.
Therefore, the study aimed to investigate the immediate effects of combined TKE with audible cues on motor unit behavior. The researchers expect that adding rhythm from the metronome will enhance neuromuscular control which may change motor unit behavior of VM muscle. The findings of the study may have helped explain the mechanism behind the acute effects of combined TKE with audible cues on VM function and their potential application in the field of physical therapy.
This study aims to investigate the immediate effect of combined TKE with audible cues on motor unit behavior in healthy participants and to investigate reliability of decomposition electromyography procedure during single leg squat.
Detailed description
A metronome will be used to provide rhythmic exercise. Participants will stand with their feet in line with their shoulders as starting position and straping at the knee. Exercise intensity is 60% of the 1RM weight. At the beginning of the exercise, participants will be asked to bend their knees following the pull of the resistance and exert force to straighten the knee (10 times/set and 3 sets). 180 seconds of resting will be allowed between sets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are 2 groups in the current study including exercise with and without audible cues.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Exercise + Audible CuesTerminal Knee Extension Exercise with Audible Cues |
| Control group | Active comparator | Behavioral: ExerciseTerminal Knee Extension Exercise without Audible Cues |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged range between 18 and 30 years
- BMI of 18.5-25 kg/m2
- Male or female
- Lightly active or sedentary {Physical activity level (PAL= 1.4-1.69)}
Key exclusion criteria (3 listed)
- History of serious injury or operation of lower back and lower extremities such as fracture
- Musculoskeletal problems of lower back and lower extremities in 6 months before the study
- Single-leg stance test < 43 seconds (26). and range of weight-bearing lunge test < 9.1 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise + Audible CuesAlso: MetronomeCombined Terminal Knee Extension Exercise with Audible Cues | Behavioural | Experimental group |
| ExerciseTerminal Knee Extension Exercise | Behavioural | Control group |
Primary outcome
Motor unit firing rate
Time frame: At the end of Cycle 1 (each cycle is 1 day)
one parameter to explain the motor unit behavior of vastus medialis muscle
Peak motor action potential
Time frame: At the end of Cycle 1 (each cycle is 1 day)
one parameter to explain the motor unit behavior of vastus medialis muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 41402906Suntornon P, Kiratisin P, Sinsurin K, Nitkotom S, Sonsukong A, Thong-On S, Watcharakeunkhan P, Sakunkaruna T. Exercise synchronized with audible cues preserves motor unit action potential: a randomized control trial study. BMC Sports Sci Med Rehabil. 2025 Dec 17;18(1):64. doi: 10.1186/s13102-025-01490-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + Audible Cues and Exercise in people with Muscle Weakness, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor unit firing rate (time frame: At the end of Cycle 1 (each cycle is 1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.