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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411278
Other study ID # IMPDO1
Secondary ID
Status Completed
Phase N/A
First received January 18, 2018
Last updated February 22, 2018
Start date December 12, 2017
Est. completion date February 22, 2018

Study information

Verified date February 2018
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 22, 2018
Est. primary completion date January 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- active soccer player in of the 5th devision

Exclusion Criteria:

- health problems

- medication with impact on the endpoints

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Institute of Medical Physics, University Erlangen-Nurnberg Erlangen Bavaria

Sponsors (1)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic maximum leg strength 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 Rating of perceived exertion (RPE) 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
Secondary Creatine kinase (CK) Creatine kinase (CK) level is analysed out of the serum using the Beckmann Coulter Inc. device (Brea, USA). prae fatiguing exercise and 48hours post
Secondary Delayed Onset Muscle Soreness (DOMS) 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
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