- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03411278
Effect of Deep Oscillation Treatment as a Method for Recovery in Soccer
Effect of Deep Oscillation Treatment as a Method for Recovery After Fatiguing Soccer Training. A Randomized Cross-Over Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bavaria
-
Erlangen, Bavaria, Germany, 91052
- Institute of Medical Physics, University Erlangen-Nurnberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- active soccer player in of the 5th devision
Exclusion Criteria:
- health problems
- medication with impact on the endpoints
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
No Intervention: No intervention, control
No intervention
|
What is the study measuring?
Primary Outcome Measures
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IMPDO1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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