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Delayed Onset Muscle SorenessDOMSNCT06535321

Delayed Onset Muscle Soreness of Athletes

A study testing vibration training, Y-shaped kinesio taping and Combined vibration training and Y-shaped kinesio taping in people with Delayed Onset Muscle Soreness, run by Chengdu Sport University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study Design: This study was approved by the Human Experiment Ethics Committee of Chengdu Sport University (No: 2103). Based on previous research data, G-power software was used to calculate that at least 40 samples were needed. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Delayed Onset Muscle Soreness
What is being tested?
vibration training, Y-shaped kinesio taping and Combined vibration training and Y-shaped kinesio taping
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
No sites listed yet
Study dates
20 Aug 2024to 15 Sep 2024
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

  • Athletes who performed regular training, ranked in the top 3 in a provincial competition and trained at least 5days per week, with a minimum of 4 h each day.
  • This training encompassed, but was not limited to, strength training, endurance training, skill drills and competitive preparation.
  • This study was in line with the Declaration of Helsinki, and the participants were aware of the study intention and signed informed consent.

Who cannot join

  • Lower limb joint injury and systematic exercise training in the last week.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Effects of Vibration Training Combined With Kinesio Taping on Delayed Onset Muscle Soreness of Athletes' Knee Joints: A Randomised Controlled Trial

Study Design:

This study was approved by the Human Experiment Ethics Committee of Chengdu Sport University (No: 2103).

Read more

Based on previous research data, G-power software was used to calculate that at least 40 samples were needed.

Participants:

A total of 45 track and field athletes from Sichuan Province, China, were recruited during the off-season in 2024. They were randomly assigned to the vibration group, kinesio taping group, combined group, and control group.

All participants signed informed consent forms and adhered to the Declaration of Helsinki.

DOMS Modeling:

Following previous research, a delayed onset muscle soreness (DOMS) model for athletes\' knee joints was established through downhill running.

Detailed oxygen uptake tests were conducted on all participants one week before DOMS modeling, and records were made one week after DOMS modeling.

Intervention Measures:

The vibration group received vibration training immediately after DOMS modeling.

The kinesio taping group had Y-shaped kinesio taping applied 30 minutes before DOMS modeling.

The combined group received both vibration training and kinesio taping simultaneously.

Assessment Methods:

The degree of pain at the DOMS site for participants was evaluated using a Visual Analogue Scale (VAS).

The concentration of creatine kinase (CK) in the serum of participants was detected using an RT-9600 automatic biochemical analyzer, and serum interleukin-6 (IL-6) was detected by enzyme-linked immunosorbent assay (ELISA).

An IsoMed 2000 isokinetic tester was used to perform a 60°/s extension test on the participants\' knees.

Data Collection:

VAS scores, serum CK and IL-6 levels, and peak torque of knee extension were collected at different time points before and after DOMS modeling.

Read the detailed description

Materials and Methods Participants This study was approved by the Human Experiment Ethics Committee of Chengdu Sport University (No: 2103). We referred to our previous research on the effect of vibration training on DOMS in athletes1 and the research on the effect of kinesio taping on DOMS in athletes. Considering the experimental design of four groups and five measurements per group, about 5% of the samples were lost. The VAS scores, IL-6 levels and CK levels as indicators of DOMS exhibited high sensitivity and specificity. Using G-power software, the effect size of 0.3 was selected.1,12,14 Power was set at 0.8, and the significance level was set at 0.05. At least 40 samples were needed for calculation.

Track and field athletes from Sichuan Province, China, were recruited during the off-season in 2024. Eligibility criteria were as follows: athletes who performed regular training, ranked in the top 3 in a provincial competition and trained at least 5days per week, with a minimum of 4 h each day. This training encompassed, but was not limited to, strength training, endurance training, skill drills and competitive preparation. The study was in line with the Declaration of Helsinki, and the participants were aware of the study intention and signed informed consent. Exclusion criteria were as follows: lower limb joint injury and systematic exercise training in the last week. A total of 45 participants (male/female: 26/19) meeting the criteria were recruited, and no sample loss was observed throughout the experimental process. The participants were divided into the vibration group (n = 11), kinesio group (n =11), combined group (vibration training + kinesio taping, n = 12) and control group (n = 11) by digital random grouping. No statistically in age, height and body mass amongst groups were observed.

DOMS Modelling Referring to our previous experimental design for DOMS modelling of athletes' knee joints,1 we performed a detailed oxygen uptake test (Cortex Cardiopulmonary Function Test System, Model: Metalyzer 3B, Germany) on all participants at 1 week before DOMS modelling. A detailed record was made 1 week after DOMS modelling. Participants performed downhill running on a treadmill (ICON, Model: NETL28717, USA; gradient of -10°, 5 groups, 8 min/group, 2 min of flat walking between groups). According to the maximum oxygen uptake, exercise intensity was matched for each participant, ensuring that all participants included had similar aerobic capacity and could maintain similar intensity during downhill running to complete DOMS modelling. Participants wore a Polar watch (Finland, Model: M430) throughout the course to monitor their heart rate, ensuring that 80% of maximum heart rate was maintained during downhill running. If the heart rate was too low or too high, the treadmill speed was adjusted appropriately. Within 72 h after DOMS modelling, we followed up with the participants to ensure that they did not undergo other training activities or treatments. Pain is a significant indicator of DOMS. In this study, the success of DOMS modelling was determined by comparing the VAS scores of participants immediately after modelling with the baseline scores. We observed that the average VAS scores for knee joint pain increased from 0.11 (0.01-0.21) to 2.21 (0.54-3.53) amongst all participants. Thus, the participants experienced varying degrees of DOMS.

The following interventions were performed on each group in this study. For the vibration group, vibration training was performed immediately after DOMS modelling. For the kinesio group, Y-shaped kinesio taping was performed 30 min before DOMS modelling. After modelling, when the vibration platform is closed, all participants of the kinesio group and control group completed the same action as vibration training. For the combined group, the vibration group and kinesio group interventions were performed simultaneously.

Vibration Training On the basis of our previous experimental design and research results of vibration training intervention for athletes, a vibration training intervention with a frequency of 50 Hz, an amplitude of 3 mm and a duration of 10 min was selected.1 Using a Power Plate vibrating platform (Model: Power Plate pro5TM, USA), vibration training was performed on the participants of the vibration group and combined group who had completed DOMS modelling under the guidance of the experimenter. The participants performed a half squat (3 min) and a lunge pull (3.5 min on each side) on the vibrating platform.1 The kinesio group and control group participants performed the same number of sets and times as the vibration group and combined group participants when the vibrator was turned off. Vibration training was performed only once, immediately after DOMS molding.

Kinesio Taping Y-shaped kinesio taping was performed 30 min before DOMS modelling.14 The participants took a sitting position, keeping their knees bent at 90°. Professional physiotherapists used 5 cm × 5 m intramuscular adhesive tape (LP Support, USA, size: 5 cm × 5 m, colour: blue) to tape the bilateral vastus medialis, vastus lateralis and rectus femoris in a 'Y' shape (stretched to 125% of the original length).16 To avoid the detachment of the muscle tape, we re-taped the same operation at 24, 48 and 72 h. During DOMS modelling, most of the participants did not lose the muscle tape, but some participants lost part of the tape, which was re-taped immediately.

This study evaluated the VAS scores, serum CK and IL-6 levels and peak torque of knee extension (60 °/s) before DOMS modelling (baseline and at 24 h before DOMS modelling) and after vibration training (immediately), 24 h, 48 h and 72 h of the participants in the four groups.

VAS Testing The pain degree of the participants at the DOMS site was evaluated by VAS. The participants were asked to draw a vertical line on a 10 cm straight line (0 cm was painless, and 10 cm was the most painful, scored 0-10. The left and right knee joints were drawn once each, and the mean was processed.

Serum IL-6 and CK Testing Our previous methods provide further details.1 About 3 mL of venous blood was collected from the participants, and the CK concentration of the participants at five time points was detected by using an RT-9600 automatic biochemical analyser (kit provided by Shanghai Lanxing Biotechnology Co., Ltd.). Serum IL-6 was detected by enzyme-linked immunosorbent assay (kit provided by Shanghai Varan Biotechnology Co., Ltd.).

Isokinetic Knee Testing An IsoMed 2000 isokinetic tester from Germany was used to perform 60°/s (three times) extension test on the participants' knee. The participants were in a sitting position, and the trunk and hip joints were fixed with a wide binding. The knee joint extension mode was selected with the joint activity of 80°, and the analytical index was peak torque; the test data were averaged on the left and right sides.

Being tested
vibration training, Y-shaped kinesio taping, Combined vibration training and Y-shaped kinesio taping
Keywords
Delayed Onset Muscle Soreness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vibration trainingOther

    After modelling, when the vibration platform is closed, all participants of the control group completed the same action as vibration training.

  • vibration trainingOther

    For the vibration group, vibration training was performed immediately after DOMS modelling.

  • Y-shaped kinesio tapingOther

    For the kinesio group, Y-shaped kinesio taping was performed 30 min before DOMS modelling.

  • Combined vibration training and Y-shaped kinesio tapingOther

    For the combined group, the vibration group and kinesio group interventions were performed simultaneously.

Study groups in NCT06535321
Study groupRoleWhat they receive
ControlPlacebo comparatorAfter modelling, when the vibration platform is closed, all participants of the control group completed the same action as vibration training.
Receives: Other: vibration training
Vibration groupExperimentalFor the vibration group, vibration training was performed immediately after DOMS modelling.
Receives: Other: vibration training
Kinesio groupExperimentalFor the kinesio group, Y-shaped kinesio taping was performed 30 min before DOMS modelling.
Receives: Other: Y-shaped kinesio taping
Combined groupExperimentalFor the combined group, the vibration group and kinesio group interventions were performed simultaneously.
Receives: Other: vibration training; Other: Y-shaped kinesio taping; Other: Combined vibration training and Y-shaped kinesio taping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS Testing

    The pain degree of the participants at the DOMS site was evaluated by VAS. The participants were asked to draw a vertical line on a 10 cm straight line (0 cm was painless, and 10 cm was the most painful, scored 0-10. The left and right knee joints were drawn once each, and the mean was processed.

    Measured: 7 Days

  2. Serum IL-6 Testing

    About 3 mL of venous blood was collected from the participants, and the CK concentration of the participants at five time points was detected by using an RT-9600 automatic biochemical analyser (kit provided by Shanghai Lanxing Biotechnology Co., Ltd.).

    Measured: 7 Days

  3. CK Testing

    About 3 mL of venous blood was collected from the participants. Serum IL-6 was detected by enzyme-linked immunosorbent assay (kit provided by Shanghai Varan Biotechnology Co., Ltd.).

    Measured: 7 Days

  4. Isokinetic Knee Testing

    An IsoMed 2000 isokinetic tester from Germany was used to perform 60°/s (three times) extension test on the participants' knee. The participants were in a sitting position, and the trunk and hip joints were fixed with a wide binding. The knee joint extension mode was selected with the joint activity of 80°, and the analytical index was peak torque; the test data were averaged on the left and right sides.

    Measured: 7 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start20 Aug 2024 (estimated)
  3. Primary completion10 Sep 2024 (estimated)
  4. Study completion15 Sep 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535321
Sponsor's protocol ID
No: 2103
Other IDs
2024NSFSC0681
Acronym
DOMS
Status last verified
Jul 2024
First submitted
26 Jul 2024
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing vibration training, Y-shaped kinesio taping and Combined vibration training and Y-shaped kinesio taping in people with Delayed Onset Muscle Soreness, run by Chengdu Sport University.

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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shuwan Chang, Dr (+8618280314728, changshuwan1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Testing (time frame: 7 Days). The study lists 4 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 2 Aug 2024.

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