Delayed-onset Muscle SorenessNCT03986242
Vibration Rolling, Non- Vibration Rolling,and Static Stretching for Delayed-onset Muscle Soreness
A study testing rolling, Vibration rolling and static stretching in people with Delayed-onset Muscle Soreness, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Delayed-onset muscle soreness (DOMS) is an acute micro-trauma or inflammatory response experienced in the most runners; and, it concurrently impairs athletic performance and may increase the risk of sports injury. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed-onset Muscle Soreness
- What is being tested?
- rolling, Vibration rolling and static stretching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2018to 6 Jun 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recruit runners of regular sports ages 20-40
Who cannot join
- Less than 3 athletes per week.
- Cardiovascular disease.
- History of asthma.
- Musculoskeletal injury within 6 months.
- Previous fracture surgery.
- Neurological symptoms.
Show all 10Show fewer
- Taking anti-inflammatory drugs.
- Taking high blood pressure and diabetes.
- Bad habits such as smoking, drinking.
- Not being able to cooperate with time detection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vibration Rolling, Non- Vibration Rolling,and Static Stretching for Delayed-onset Muscle Soreness on Physiological Changes and Recovery of Athletic Performance in Runners
Delayed-onset muscle soreness (DOMS) is an acute micro-trauma or inflammatory response experienced in the most runners; and, it concurrently impairs athletic performance and may increase the risk of sports injury. Alleviating the symptoms of DOMS strategies are various; however, the specific recovery way remains unconcluded. Furthermore, few studies have investigated the effects of vibrating roller on alleviating the symptoms of DOMS and understand the biochemical changes in response to recovery of athletic performance. Therefore, this study hypothesizes that vibration rolling (VR) could provide a self-myofascial release. Meanwhile, vibration exercise could transmit vibration to specific muscle groups to decrease inflammation in corresponding to reduce muscular pain. Therefore, it could offer positive effects including improvements of flexibility, muscle stiffness, visual analog scale (VAS) for pain, jump, and dynamic balance.
Read the detailed description
Background: Delayed-onset muscle soreness (DOMS) is an acute micro-trauma or inflammatory response experienced in the most runners; and, it concurrently impairs athletic performance and may increase risk of sports injury. Alleviating the symptoms of DOMS strategies are various; however, the specific recovery way remains unconcluded. Furthermore, few studies have investigated that the effects of vibrating roller on alleviating the symptoms of DOMS, and understand the biochemical changes in response to recovery of athletic performance. Therefore, this study hypothesizes that vibration rolling (VR) could provide self-myofascia release. Meanwhile, vibration exercise could tramsit vibration to speific muscle groups to decrease inflammation in corresponding to reduce muscular pain. Therefore, it could offer positve effects including improvements of flexability, muscle stiffness, visual analog scale (VAS) for pain, jmup, and dynmaic balance. Purpose: To investigate VR, non-vibration rolling (NVR), and static stretching for DOMS on physiological changes and recovery of athletic performance in runners. Methods: Thirty healthy and recreationally adult runners will be voluntarily recruited in the experiment. Participant will be induced DOMS on the treadmill exercise firstly. Next, participants will be matched up and randomly assigned to the VR group, NVR group or static stretching group treatment. Each participant will be instructed to 20-minutes treatment on bilateral muscles including gluteus, anterior, and posterior thighs as well as anterior, and posterior legs. All subjects will receive blood analysis (leukocyte, lymphocyte, creatine kinase, c-reactive protein, interleukin-6) and perform flexibility muscular stiffness, VAS for pain, counter movement jump, Y balance tests on lower limb before exercise and after 24hour and 48 hour interventions. Expected outcomes: VR could effectively alleviate the symptoms of DOMS including decreasing inflammatory biochemical values, decreasing muscular stiffness, reducing muscular pain, and increasing flexibility and jump ability as well as improving dynamic balance on lower limb. This data may provide in alleviating the symptoms of DOMS to healthy populations, athletes, and medical team members.
Key Words: Delayed-onset muscle soreness, vibration therapy, foam roller, stretching exercise, recovery, performance
- Conditions
- Delayed-onset Muscle Soreness
- Being tested
- rolling, Vibration rolling, static stretching
- Keywords
- Delayed-onset muscle soreness, vibration therapy, foam roller, stretching exercise, recovery, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rollingDevice
use non- vibration rolling and the total time is 20 minutes.
Vibration rollingDevice
use Vibration rolling the vibration frequency is 28 Hz, and the total time is 20 minutes.
static stretchingOther
static stretching and the total time is 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| static stretchin | Experimental | Static extremity muscles of the lower extremities, including: gluteal muscles (major muscle group: gluteus maximus), anterior thigh muscles (strand rectus, medial femoral muscle, lateral femoral muscle, medial femoral muscle), posterior thigh muscles (main muscle) Group: semimembranosus, semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). 4 groups per muscle group, 30 seconds/group Receives: Other: static stretching |
| non- vibration rolling | Experimental | Lower limb part. Such as: gluteal muscle (main muscle group: gluteus maximus), anterior thigh muscle group (straight rectus, medial femoral muscle, lateral femoral muscle, femoral intermediate muscle), posterior thigh muscle group (main muscle group: semimembranosus, Semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). Each leg of each pair performs 30 seconds/group for a total of 4 groups for a total time of 20 minutes. Receives: Device: rolling |
| Vibration rolling | Experimental | Lower limb part. Such as: gluteal muscle (main muscle group: gluteus maximus), anterior thigh muscle group (straight rectus, medial femoral muscle, lateral femoral muscle, femoral intermediate muscle), posterior thigh muscle group (main muscle group: semimembranosus, Semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). Each muscle group of each foot performs 30 seconds/group, a total of 4 groups, the vibration frequency is 28 Hz, and the total time is 20 minutes. Receives: Device: Vibration rolling |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Mainly used as an indicator of inflammation
Measured: Change from baseline at 3 days
Interleukin-6
Used as an indicator of inflammation
Measured: Change from baseline at 3 days
Secondary outcomes (5)
Flexibility
Sports performance by range of motion (unit=degree). Popliteal angle test to test the range of motion the hamstring. =>Amount of knee extension with hip flexed at 90º
Ely's test to test the range of motion the rectus femoris.
=>The therapist is standing next to the patient, at the side of the leg that will be tested.
One hand should be on the lower back, the other holding the leg at the heel. Passively flex the knee in a rapid fashion. The heel should touch the buttocks. Test both sides for comparison. The test is positive when the heel cannot touch the buttocks, the hip of the tested side rises up from the table, the patient feels pain or tingling in the back or legs.
Measured: Change from baseline at 3 days
Visual analog scale for pain
Measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
providing a range of scores from 0-10, the following cut points on the pain VAS have been recommended: no pain (0), mild pain(1-3), moderate pain (4-6), and severe pain (>6).
Measured: Change from baseline at 3 days
Counter movement jump
The countermovement jump (CMJ) is a simple, practical, valid, and very reliable measure of lower-body power.
As a consequence, it is no surprise that this has become a cornerstone test for many strength and conditioning coaches and sports scientists.
The CMJ has been shown to be the most reliable measure of lower-body power compared to other jump tests.
Use My jump 2 APP to measure jump height (unit=cent). <30 cm=the subject was fatigue, >30 cm=the subject was normal.
Measured: Change from baseline at 3 days
Y balance test
The YBT requires the athlete to balance on one leg whilst simultaneously reaching as far as possible with the other leg in three separate directions: anterior, posterolateral, and posteromedial.
Therefore, this test measures the athlete's strength, stability and balance in various directions.
The YBT composite score is calculated by summing the 3 reach directions and normalizing the results to the lower limb length, whereas asymmetry is the difference between right and left limb reach (1) - this is explained in greater detail in the scoring system section.
Measured: Change from baseline at 3 days
Muscle stiffness
Use Myoton PRO instrument to test the muscle stiffness. The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties.
Damped natural oscillation is induced by an exterior, low force quick-release mechanical impulse under constant pre-load.
The test muscle : Quadriceps, Hamstring, Gastrocnemius, Tibialis anterior muscle.
Measured: Change from baseline at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start23 Nov 2018
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed-onset Muscle SorenessStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Chia-Wen, Postgraduate, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986242
- Sponsor's protocol ID
- KMUHIRB-F(I)-20180006
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Rolling, Non- Vibration Rolling,and Static Stretching for Delayed-onset Muscle Soreness on Physiological Changes and Recovery of Athletic Performance in Runners
- ClinicalTrials.gov ID
- NCT03986242
- Acronym / sponsor ID
- KMUHIRB-F(I)-20180006
- Conditions
- Delayed-onset Muscle Soreness
- Keywords
- Delayed-onset muscle soreness, vibration therapy, foam roller, stretching exercise, recovery, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 14 Jun 2019 (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.
Delayed-onset muscle soreness (DOMS) is an acute micro-trauma or inflammatory response experienced in the most runners; and, it concurrently impairs athletic performance and may increase the risk of sports injury. Alleviating the symptoms of DOMS strategies are various; however, the specific recovery way remains unconcluded. Furthermore, few studies have investigated the effects of vibrating roller on alleviating the symptoms of DOMS and understand the biochemical changes in response to recovery of athletic performance. Therefore, this study hypothesizes that vibration rolling (VR) could provide a self-myofascial release. Meanwhile, vibration exercise could transmit vibration to specific muscle groups to decrease inflammation in corresponding to reduce muscular pain. Therefore, it could offer positive effects including improvements of flexibility, muscle stiffness, visual analog scale (VAS) for pain, jump, and dynamic balance.
Detailed description
Background: Delayed-onset muscle soreness (DOMS) is an acute micro-trauma or inflammatory response experienced in the most runners; and, it concurrently impairs athletic performance and may increase risk of sports injury. Alleviating the symptoms of DOMS strategies are various; however, the specific recovery way remains unconcluded. Furthermore, few studies have investigated that the effects of vibrating roller on alleviating the symptoms of DOMS, and understand the biochemical changes in response to recovery of athletic performance. Therefore, this study hypothesizes that vibration rolling (VR) could provide self-myofascia release. Meanwhile, vibration exercise could tramsit vibration to speific muscle groups to decrease inflammation in corresponding to reduce muscular pain. Therefore, it could offer positve effects including improvements of flexability, muscle stiffness, visual analog scale (VAS) for pain, jmup, and dynmaic balance. Purpose: To investigate VR, non-vibration rolling (NVR), and static stretching for DOMS on physiological changes and recovery of athletic performance in runners. Methods: Thirty healthy and recreationally adult runners will be voluntarily recruited in the experiment. Participant will be induced DOMS on the treadmill exercise firstly. Next, participants will be matched up and randomly assigned to the VR group, NVR group or static stretching group treatment. Each participant will be instructed to 20-minutes treatment on bilateral muscles including gluteus, anterior, and posterior thighs as well as anterior, and posterior legs. All subjects will receive blood analysis (leukocyte, lymphocyte, creatine kinase, c-reactive protein, interleukin-6) and perform flexibility muscular stiffness, VAS for pain, counter movement jump, Y balance tests on lower limb before exercise and after 24hour and 48 hour interventions. Expected outcomes: VR could effectively alleviate the symptoms of DOMS including decreasing inflammatory biochemical values, decreasing muscular stiffness, reducing muscular pain, and increasing flexibility and jump ability as well as improving dynamic balance on lower limb. This data may provide in alleviating the symptoms of DOMS to healthy populations, athletes, and medical team members.
Key Words: Delayed-onset muscle soreness, vibration therapy, foam roller, stretching exercise, recovery, performance
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| static stretchin | Experimental | Other: static stretchingStatic extremity muscles of the lower extremities, including: gluteal muscles (major muscle group: gluteus maximus), anterior thigh muscles (strand rectus, medial femoral muscle, lateral femoral muscle, medial femoral muscle), posterior thigh muscles (main muscle) Group: semimembranosus, semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). 4 groups per muscle group, 30 seconds/group |
| non- vibration rolling | Experimental | Device: rollingLower limb part. Such as: gluteal muscle (main muscle group: gluteus maximus), anterior thigh muscle group (straight rectus, medial femoral muscle, lateral femoral muscle, femoral intermediate muscle), posterior thigh muscle group (main muscle group: semimembranosus, Semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). Each leg of each pair performs 30 seconds/group for a total of 4 groups for a total time of 20 minutes. |
| Vibration rolling | Experimental | Device: Vibration rollingLower limb part. Such as: gluteal muscle (main muscle group: gluteus maximus), anterior thigh muscle group (straight rectus, medial femoral muscle, lateral femoral muscle, femoral intermediate muscle), posterior thigh muscle group (main muscle group: semimembranosus, Semitendinosus, biceps femoris), anterior muscles of the calf (anterior tibialis anterior muscle, extensor muscle), and posterior muscles of the calf (gastrocnemius, soleus muscle). Each muscle group of each foot performs 30 seconds/group, a total of 4 groups, the vibration frequency is 28 Hz, and the total time is 20 minutes. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recruit runners of regular sports ages 20-40
Key exclusion criteria (10 listed)
- Less than 3 athletes per week.
- Cardiovascular disease.
- History of asthma.
- Musculoskeletal injury within 6 months.
- Previous fracture surgery.
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 |
|---|---|---|
| rollinguse non- vibration rolling and the total time is 20 minutes. | Device | non- vibration rolling |
| Vibration rollinguse Vibration rolling the vibration frequency is 28 Hz, and the total time is 20 minutes. | Device | Vibration rolling |
| static stretchingstatic stretching and the total time is 20 minutes. | Other | static stretchin |
Primary outcome
C-reactive protein
Time frame: Change from baseline at 3 days
Mainly used as an indicator of inflammation
Interleukin-6
Time frame: Change from baseline at 3 days
Used as an indicator of inflammation
5 secondary outcomes
Flexibility
Time frame: Change from baseline at 3 days
Visual analog scale for pain
Time frame: Change from baseline at 3 days
Counter movement jump
Time frame: Change from baseline at 3 days
Y balance test
Time frame: Change from baseline at 3 days
Muscle stiffness
Time frame: Change from baseline at 3 days
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 2019.
- Individual participant dataSharing planned: No
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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.
Wu Chia-Wen, Postgraduate principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rolling, Vibration rolling and static stretching in people with Delayed-onset Muscle Soreness, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 1 inclusion and 10 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 2019. 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?
C-reactive protein (time frame: Change from baseline at 3 days). 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?
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 2019.