Effect of Deep Oscillation Treatment as a Method for Recovery in Soccer

February 22, 2018 updated by: University of Erlangen-Nürnberg Medical School

Effect of Deep Oscillation Treatment as a Method for Recovery After Fatiguing Soccer Training. A Randomized Cross-Over Study

The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. We investigate deep oscillation (DO) self treatment as a measure to promote regeneration, hypothesizing that DO leads to an accelerated recovery within the first 48h after fatiguing training with positive effect on the maximum strength, rated perceived exertion, creatinkinase (CK) values and DOMS compared to no treatment after an .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Recovery time between in association football (soccer) often is not long enough to completely restore. Insufficient recovery can result in a reduced performance and suboptimal development in the training process and a higher risk for injuries. The purpose of this study is to evaluate the effects of Deep Oscillation (DO) self-treatment on recovery after fatiguing soccer training. Deep Oscillation is a unique method which is characterized by an alternating electrostatic which results in a deep resonance vibration of patients tissue.

Methods: In a randomized crossover study design including 10 soccer players of the 5th german devision the following parameters will be evaluated directly before and 48h after an fatiguing soccer specific exercise: Maximum isokinetic strength of the leg and hip extensors and flexors (Con-Trex® Leg Press, Physiomed, Germany), rating of perceived exertion (RPE) during isokinetic testing (Borg scale 6-20) and creatine kinase (CK) serum levels. Delayed Onset Muscle Soreness (DOMS; visual analogue scale 1-10) will be recorded 24 and 48h post-exercise. At random half of the group will perform a DO self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. 4 weeks later in a cross-over design the same procedure will be conducted again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91052
        • Institute of Medical Physics, University Erlangen-Nurnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • active soccer player in of the 5th devision

Exclusion Criteria:

  • health problems
  • medication with impact on the endpoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deep Oscillation (DO) self treatment
DO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2). The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order.
Device: Deep Oscillation (DO)
DO self treatment with the device "mobile" (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2).The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order.
Other Names:
  • electrotherapy
  • electrostatic fields
No Intervention: No intervention, control
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isokinetic maximum leg strength
Time Frame: prae fatiguing exercise and 48hours post
Maximum isokinetic strength of the leg- extensors and flexors is tested using a ConTrex isokinetic leg press (Physiomed, Laipers-dorf, Germany).
prae fatiguing exercise and 48hours post

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rating of perceived exertion (RPE)
Time Frame: during isokinetic testing prae fatiguing exercise and 48hours post
Rating of perceived exertion (RPE) is obtained immediately after the maximum strength test, using Borg´s 20-point scale.
during isokinetic testing prae fatiguing exercise and 48hours post
Creatine kinase (CK)
Time Frame: prae fatiguing exercise and 48hours post
Creatine kinase (CK) level is analysed out of the serum using the Beckmann Coulter Inc. device (Brea, USA).
prae fatiguing exercise and 48hours post
Delayed Onset Muscle Soreness (DOMS)
Time Frame: 24hours and 48hours postexercise
Self reported Delayed Onset Muscle Soreness (DOMS) in the lower extremity on the day after the training and the day after using a visual analogue scale (VAS) from 1 (no muscle soreness) to 10 (maximum muscle soreness) .
24hours and 48hours postexercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMPDO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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