search
Back to results

Effects of Compression Wear on Muscle Soreness (COMDOME)

Primary Purpose

Muscular Regeneration, Repeated Bout Effect of WB-EMS

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Compression
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Regeneration

Eligibility Criteria

25 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Medical Physics University of Erlangen-Nurnberg
  • Institute of Medical Physics, University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Compressive garment

No compression garment

Arm Description

Groups wear compression garment after WB-EMS induced muscle soreness

Groups wear no compression garment after WB-EMS induced muscle soreness

Outcomes

Primary Outcome Measures

Maximum isokinetic leg extensor strength
Changes of isokinetic leg extensor strength during the intervention period

Secondary Outcome Measures

Perceived physical state
Changes of perceived physical state as determined by the WKV-scale (Kleinert, 2001) during the intervention period
Resting metabolic rate
Changes of resting metabolic rate during the intervention period
Myoglobin
Changes of myoglobin-levels during the intervention period
Heart rate variability
Changes of Heart rate variability during the intervention period
creatine-kinase (CK) concentration
Changes of CK-levels during the intervention period

Full Information

First Posted
January 24, 2018
Last Updated
July 4, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Sport University, Cologne
search

1. Study Identification

Unique Protocol Identification Number
NCT03417323
Brief Title
Effects of Compression Wear on Muscle Soreness
Acronym
COMDOME
Official Title
Effects of Compression Wear on Whole-body Electromyostimulation and Exercise-induced Muscle Soreness. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
February 22, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Sport University, Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Regeneration, Repeated Bout Effect of WB-EMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compressive garment
Arm Type
Experimental
Arm Description
Groups wear compression garment after WB-EMS induced muscle soreness
Arm Title
No compression garment
Arm Type
No Intervention
Arm Description
Groups wear no compression garment after WB-EMS induced muscle soreness
Intervention Type
Other
Intervention Name(s)
Compression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum isokinetic leg extensor strength
Description
Changes of isokinetic leg extensor strength during the intervention period
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Perceived physical state
Description
Changes of perceived physical state as determined by the WKV-scale (Kleinert, 2001) during the intervention period
Time Frame
5 days
Title
Resting metabolic rate
Description
Changes of resting metabolic rate during the intervention period
Time Frame
5 days
Title
Myoglobin
Description
Changes of myoglobin-levels during the intervention period
Time Frame
5 days
Title
Heart rate variability
Description
Changes of Heart rate variability during the intervention period
Time Frame
5 days
Title
creatine-kinase (CK) concentration
Description
Changes of CK-levels during the intervention period
Time Frame
5 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Lötzerich, PhD
Organizational Affiliation
German Sport University, Cologne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wolfgang Kemmler, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Physics University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Institute of Medical Physics, University of Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26498468
Citation
Kemmler W, Teschler M, Bebenek M, von Stengel S. [(Very) high Creatinkinase concentration after exertional whole-body electromyostimulation application: health risks and longitudinal adaptations]. Wien Med Wochenschr. 2015 Nov;165(21-22):427-35. doi: 10.1007/s10354-015-0394-1. Epub 2015 Oct 26. German.
Results Reference
background
Links:
URL
http://www.imp.uni-erlangen.de/
Description
Institution homepage

Learn more about this trial

Effects of Compression Wear on Muscle Soreness

We'll reach out to this number within 24 hrs