- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417323
Effects of Compression Wear on Muscle Soreness (COMDOME)
July 4, 2018 updated by: University of Erlangen-Nürnberg Medical School
Effects of Compression Wear on Whole-body Electromyostimulation and Exercise-induced Muscle Soreness. A Randomized Controlled Trial.
The study address two main topics:
- The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced muscle soreness in young adults
- The repeated bout effect of one intense session of WB-EMS as determined by various regeneration parameters
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Using a cross-over design we applied 2 intense WB-EMS training sessions either with or without subsequent wearing of compression garments (long tights) for 5 days at baseline and after a washout period of 4 weeks.
Healthy young to middle aged athletes used compression garments immediately postexercise for 24 hours and further 12 h during the day.
Blood samples, questionnaires, resting metabolic rate and performance test were applied prior and 24, 48,72 and 96 h post-exercise consistently without wearing compression garments.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- 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
-
-
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Erlangen, Germany, 91052
- Institute of Medical Physics University of Erlangen-Nurnberg
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Erlangen, Germany, 91052
- Institute of Medical Physics, University of 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
Ages Eligible for Study
25 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy athletes with >5 years of experience in competition balls sports and corresponding discipline specific resistance exercise
Exclusion Criteria:
- diseases and medication affecting muscle metabolism
- contraindication for WB-EMS
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Compressive garment
Groups wear compression garment after WB-EMS induced muscle soreness
|
Participants in the treatment group wear compression garment after intense WB-EMS application for 24 h, and 12 h for day 2, 3, 4 post WB-EMS.
|
No Intervention: No compression garment
Groups wear no compression garment after WB-EMS induced muscle soreness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum isokinetic leg extensor strength
Time Frame: 5 days
|
Changes of isokinetic leg extensor strength during the intervention period
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived physical state
Time Frame: 5 days
|
Changes of perceived physical state as determined by the WKV-scale (Kleinert, 2001) during the intervention period
|
5 days
|
Resting metabolic rate
Time Frame: 5 days
|
Changes of resting metabolic rate during the intervention period
|
5 days
|
Myoglobin
Time Frame: 5 days
|
Changes of myoglobin-levels during the intervention period
|
5 days
|
Heart rate variability
Time Frame: 5 days
|
Changes of Heart rate variability during the intervention period
|
5 days
|
creatine-kinase (CK) concentration
Time Frame: 5 days
|
Changes of CK-levels during the intervention period
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Helmut Lötzerich, PhD, German Sport University, Cologne
- Principal Investigator: Wolfgang Kemmler, PhD, University of Erlangen-Nürnberg Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2017
Primary Completion (Actual)
February 22, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
January 24, 2018
First Posted (Actual)
January 31, 2018
Study Record Updates
Last Update Posted (Actual)
July 6, 2018
Last Update Submitted That Met QC Criteria
July 4, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Compression_DOMS_EMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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