FatigueNCT04900922
Changes in Shoulder Kinematics Following an Isokinetic Fatigue Protocol in Tennis Players
An observational study of Fatigue, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
A typical tennis match can take 1 to 5 hours. Tennis serve can be divided into eight stages and three phases. Injuries usually happen in the cocking stage and acceleration phase of the serve, where it requires large shoulder range of motion and proper scapular motion, including sufficient scapular upper rotation… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- isokinetic dynamometer
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2021to 5 Mar 2022
- Phase
- Observational
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All of the subjects are healthy during the test to avoid the risk of injury.
Who may be able to join
- Healthy tennis players
- Age ranges from 20-45 years old
- Engaging in tennis for at least 1 year
- Routine training 3 times a week
- No history of cervical and/or shoulder injury in the past one year, or injury with VAS (visual analog pain scale) lower than 3 and without cervical-shoulder pain 7 days before testing
- No operation on the shoulder, no shoulder subluxation, labral tear, and rotator cuff tear.
- Neer's test, empty can test, and Hawkins Kennedy test are negative.
Who cannot join
- History of cervical and/or shoulder injury in the past one year, or injury with VAS (visual analog pain scale) bigger than 3 and with cervical-shoulder pain 7 days before testing
- Operation on the shoulder, history of shoulder subluxation, labral tear, and rotator cuff tear.
- One of the three test results is positive: Neer's test, empty can test, and Hawkins Kennedy test.
- Perform upper extremity resist training and tennis training 24 hours before testing.
Trial locations and contacts
1 site in 1 country.
About this study
A typical tennis match can take 1 to 5 hours. Tennis serve can be divided into eight stages and three phases. Injuries usually happen in the cocking stage and acceleration phase of the serve, where it requires large shoulder range of motion and proper scapular motion, including sufficient scapular upper rotation, external rotation, and posterior tilt to produce a powerful serve. Altered shoulder kinematics are associated with shoulder injuries in tennis players, including delayed shoulder horizontal adduction, and early external rotation. Due to the long duration and repetition of activity in a match, fatigue may happen and result in decreases in sensory input, passive range of motion, ball speed, and muscle strength. These changes may further lead to altered glenohumeral and scapular kinematics. However, previous studies mainly focused on the effects of fatigue on scapular kinematics in constrain movements and applied different fatigue protocols, which lead to inconsistent results. Tennis serve in cocking stage and the acceleration phase require high activation of shoulder external rotators and internal rotators, including infraspinatus, pectoralis major, subscapularis, latissimus dorsi and serratus anterior. However, to our knowledge, no study has investigated how fatigue of shoulder rotators influences shoulder kinematic as well as scapular kinematics during the late cocking stage and acceleration phase of tennis serve. Therefore, the investigators aim to investigate whether fatigue of shoulder rotator affects shoulder kinematics in healthy tennis players during the late cocking stage and acceleration phase of tennis serve.This is a single group, pretest-posttest measurement study. In a fatigue protocol, investigators use an isokinetic dynamometer to induce fatigue of shoulder rotators. Outcome measures will be tested before and after the fatigue protocol, including peak torque of shoulder rotators, humerothoracic kinematics, scapulothoracic kinematics, and median power frequency recorded by a surface electromyography. Peak torque of shoulder rotators will be measured with an isokinetic dynamometer. Surface electromyography will be used to measure peripheral muscle fatigue by maximum voluntary isometric contraction. Humerothoracic kinematics and scapulothoracic kinematics during a functional tennis serve and scaption will be collected with a motion capture system.
- Conditions
- Fatigue
- Being tested
- isokinetic dynamometer
- Keywords
- tennis player, shoulder kinematics, scapular kinematics, serving biomechanics, isokinetic dynamometer
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isokinetic dynamometerDevice
We will use an isokinetic dynamometer to conduct the concentric isokinetic fatigue protocol. The start position is shoulder abduction 90°, elbow flexion 90°and range of motion is set from 0 ° (internal rotation) to 90 ° (external rotation) under 120°/s. To calculate maximum torque of shoulder external and internal rotation, the subject will perform maximum isokinetic test 5 times before fatigue. Fatigue protocol include 10 sets, and each set include 32 repetitions with 30 seconds of rest between sets. The fatigue protocol will be stopped under three conditions: 1. the torque decreases 50% of maximum torque three times in one set or 2.rating of perceived exertion (RPE) abrove 15 and players can not perform the fatigue protocol or 3. finish the whole test.
| Study group | Role | What they receive |
|---|---|---|
| Healthy tennis players | Participants in this group need to perform arm elevation in the scapular plane three times and successful flat tennis serve three times before and after a fatigue protocol. Surface electromyography on infraspinatus, pectoralis major, anterior deltoid ,and latissimus dorsi will be used to detect muscle activity related to fatigue. Receives: Device: isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serve sequence pattern
Including the timing of shoulder horizontal adduction above 0 degree and the timing of shoulder external rotation above 90 degree during a tennis serve. Time would be normalized into 100 percentage and calculate the difference between shoulder horizontal adduction and external rotation described with percentage (%).
Measured: immediately after the intervention (fatigue protocol)
Scapular kinematics
Including anterior/posterior tilt, upward/downward rotation, and internal/external rotation during arm elevation in scapular plane at 30°, 60°, 90°, and 120°, and during late cocking stage of tennis serve and at the end of acceleration phase of the serve. Scapulothoracic kinematics will be calculated and will be described with degree (°).
Measured: immediately after the intervention (fatigue protocol)
Shoulder kinematics
Including shoulder external/internal rotation, horizontal adduction/abduction, elevation in the cocking stage of tennis serving and at the end of acceleration phase,will be calculated and will be described with degree (°).
Measured: immediately after the intervention (fatigue protocol)
Secondary outcomes (4)
Median frequency
The median frequency calculated from electromyographic data of infraspinatus, pectoralis major, anterior deltoid, and latissimus dorsi. The percentage change in median frequency will be calculated and will be described with percentage (%).
Measured: immediately after the intervention (fatigue protocol)
Shoulder internal and external rotation torque
The first three and the last three of shoulder rotation torque will be recorded and be described with Newton metre (Nm).
Measured: immediately after the intervention (fatigue protocol)
Relative fatigue ratio
Last three torque of shoulder external rotation and internal rotation will be divided by the first three torque of shoulder external rotation and internal rotation described with percentage (%).
Measured: immediately after the intervention (fatigue protocol)
ER/IR ratio
The torque of shoulder external rotation divided by the torque of shoulder internal rotation and will be described with ratio before and after fatigue protocol.
Measured: immediately after the intervention (fatigue protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start10 Nov 2021
- Primary completion5 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Jen Catholic University
- Responsible party
- Principal investigator, Yin-Liang Lin, National Yang Ming Chiao Tung University
- Investigators
- Yin-Liang Lin, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900922
- Sponsor's protocol ID
- C109047
- Status last verified
- Aug 2022
- First submitted
- 20 May 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Shoulder Kinematics Following an Isokinetic Fatigue Protocol in Tennis Players
- ClinicalTrials.gov ID
- NCT04900922
- Acronym / sponsor ID
- C109047
- Conditions
- Fatigue
- Keywords
- tennis player, shoulder kinematics, scapular kinematics, serving biomechanics, isokinetic dynamometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Fu Jen Catholic University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 25 May 2021 (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.
A typical tennis match can take 1 to 5 hours. Tennis serve can be divided into eight stages and three phases. Injuries usually happen in the cocking stage and acceleration phase of the serve, where it requires large shoulder range of motion and proper scapular motion, including sufficient scapular upper rotation, external rotation, and posterior tilt to produce a powerful serve. Altered shoulder kinematics are associated with shoulder injuries in tennis players, including delayed shoulder horizontal adduction, and early external rotation. Due to the long duration and repetition of activity in a match, fatigue may happen and result in decreases in sensory input, passive range of motion, ball speed, and muscle strength. These changes may further lead to altered glenohumeral and scapular kinematics. However, previous studies mainly focused on the effects of fatigue on scapular kinematics in constrain movements and applied different fatigue protocols, which lead to inconsistent results. Tennis serve in cocking stage and the acceleration phase require high activation of shoulder external rotators and internal rotators, including infraspinatus, pectoralis major, subscapularis, latissimus dorsi and serratus anterior. However, to our knowledge, no study has investigated how fatigue of shoulder rotators influences shoulder kinematic as well as scapular kinematics during the late cocking stage and acceleration phase of tennis serve. Therefore, the investigators aim to investigate whether fatigue of shoulder rotator affects shoulder kinematics in healthy tennis players during the late cocking stage and acceleration phase of tennis serve.This is a single group, pretest-posttest measurement study. In a fatigue protocol, investigators use an isokinetic dynamometer to induce fatigue of shoulder rotators. Outcome measures will be tested before and after the fatigue protocol, including peak torque of shoulder rotators, humerothoracic kinematics, scapulothoracic kinematics, and median power frequency recorded by a surface electromyography. Peak torque of shoulder rotators will be measured with an isokinetic dynamometer. Surface electromyography will be used to measure peripheral muscle fatigue by maximum voluntary isometric contraction. Humerothoracic kinematics and scapulothoracic kinematics during a functional tennis serve and scaption will be collected with a motion capture system.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy tennis players | – | Device: isokinetic dynamometerParticipants in this group need to perform arm elevation in the scapular plane three times and successful flat tennis serve three times before and after a fatigue protocol. Surface electromyography on infraspinatus, pectoralis major, anterior deltoid ,and latissimus dorsi will be used to detect muscle activity related to fatigue. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All of the subjects are healthy during the test to avoid the risk of injury.
Key inclusion criteria (7 listed)
- Healthy tennis players
- Age ranges from 20-45 years old
- Engaging in tennis for at least 1 year
- Routine training 3 times a week
- No history of cervical and/or shoulder injury in the past one year, or injury with VAS (visual analog pain scale) lower than 3 and without cervical-shoulder pain 7 days before testing
Key exclusion criteria (4 listed)
- History of cervical and/or shoulder injury in the past one year, or injury with VAS (visual analog pain scale) bigger than 3 and with cervical-shoulder pain 7 days before testing
- Operation on the shoulder, history of shoulder subluxation, labral tear, and rotator cuff tear.
- One of the three test results is positive: Neer's test, empty can test, and Hawkins Kennedy test.
- Perform upper extremity resist training and tennis training 24 hours before testing.
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 |
|---|---|---|
| isokinetic dynamometerWe will use an isokinetic dynamometer to conduct the concentric isokinetic fatigue protocol. The start position is shoulder abduction 90°, elbow flexion 90°and range of motion is set from 0 ° (internal rotation) to 90 ° (external rotation) under 120°/s. To calculate maximum torque of shoulder external and internal rotation, the subject will perform maximum isokinetic test 5 times before fatigue. Fatigue protocol include 10 sets, and each set include 32 repetitions with 30 seconds of rest between sets. The fatigue protocol will be stopped under three conditions: 1. the torque decreases 50% of maximum torque three times in one set or 2.rating of perceived exertion (RPE) abrove 15 and players can not perform the fatigue protocol or 3. finish the whole test. | Device | Healthy tennis players |
Primary outcome
Serve sequence pattern
Time frame: immediately after the intervention (fatigue protocol)
Including the timing of shoulder horizontal adduction above 0 degree and the timing of shoulder external rotation above 90 degree during a tennis serve. Time would be normalized into 100 percentage and calculate the difference between shoulder horizontal adduction and external rotation described with percentage (%).
Scapular kinematics
Time frame: immediately after the intervention (fatigue protocol)
Including anterior/posterior tilt, upward/downward rotation, and internal/external rotation during arm elevation in scapular plane at 30°, 60°, 90°, and 120°, and during late cocking stage of tennis serve and at the end of acceleration phase of the serve. Scapulothoracic kinematics will be calculated and will be described with degree (°).
Shoulder kinematics
Time frame: immediately after the intervention (fatigue protocol)
Including shoulder external/internal rotation, horizontal adduction/abduction, elevation in the cocking stage of tennis serving and at the end of acceleration phase,will be calculated and will be described with degree (°).
4 secondary outcomes
Median frequency
Time frame: immediately after the intervention (fatigue protocol)
Shoulder internal and external rotation torque
Time frame: immediately after the intervention (fatigue protocol)
Relative fatigue ratio
Time frame: immediately after the intervention (fatigue protocol)
ER/IR ratio
Time frame: immediately after the intervention (fatigue protocol)
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 6 Sep 2022.
- 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.
Yin-Liang Lin, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 7 inclusion and 4 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 6 Sep 2022. 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 Taiwan. 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?
Serve sequence pattern (time frame: immediately after the intervention (fatigue protocol)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2022.