NCT06535321

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

21 days

First QC Date

July 26, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

Delayed Onset Muscle Soreness

Outcome Measures

Primary Outcomes (4)

  • 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.

    7 Days

  • 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.).

    7 Days

  • 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.).

    7 Days

  • 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.

    7 Days

Study Arms (4)

Control

PLACEBO COMPARATOR

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

Other: vibration training

Vibration group

EXPERIMENTAL

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

Other: vibration training

Kinesio group

EXPERIMENTAL

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

Other: Y-shaped kinesio taping

Combined group

EXPERIMENTAL

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

Other: vibration trainingOther: Y-shaped kinesio tapingOther: Combined vibration training and Y-shaped kinesio taping

Interventions

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

Control

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

Combined groupKinesio group

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

Combined group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Liang Cheng, Dr

    Chengdu Sport University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 2, 2024

Study Start

August 20, 2024

Primary Completion

September 10, 2024

Study Completion

September 15, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share