Muscular RegenerationCOMDOMENCT03417323
Effects of Compression Wear on Muscle Soreness
A study testing Compression in people with Muscular Regeneration and Repeated Bout Effect of WB-EMS, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
The study address two main topics: 1. The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced muscle soreness in young adults 2. The repeated bout effect of one intense session of WB-EMS as determined by various regeneration parameters Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Muscular Regeneration, Repeated Bout Effect of WB-EMS
- What is being tested?
- Compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesGermany
- Study dates
- 10 Dec 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- healthy athletes with >5 years of experience in competition balls sports and corresponding discipline specific resistance exercise
Who cannot join
- diseases and medication affecting muscle metabolism
- contraindication for WB-EMS
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: 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
Read the 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.
- Being tested
- Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompressionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Compressive garment | Experimental | Groups wear compression garment after WB-EMS induced muscle soreness Receives: Other: Compression |
| No compression garment | No intervention | Groups wear no compression garment after WB-EMS induced muscle soreness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum isokinetic leg extensor strength
Changes of isokinetic leg extensor strength during the intervention period
Measured: 5 days
Secondary outcomes (5)
Perceived physical state
Changes of perceived physical state as determined by the WKV-scale (Kleinert, 2001) during the intervention period
Measured: 5 days
Resting metabolic rate
Changes of resting metabolic rate during the intervention period
Measured: 5 days
Myoglobin
Changes of myoglobin-levels during the intervention period
Measured: 5 days
Heart rate variability
Changes of Heart rate variability during the intervention period
Measured: 5 days
creatine-kinase (CK) concentration
Changes of CK-levels during the intervention period
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start10 Dec 2017
- Primary completion22 Feb 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscular RegenerationStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne
- Responsible party
- Sponsor
- Investigators
- Helmut Lötzerich, PhD, Study chair, German Sport University, CologneWolfgang Kemmler, PhD, Principal investigator, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417323
- Sponsor's protocol ID
- Compression_DOMS_EMS
- Acronym
- COMDOME
- Status last verified
- Jul 2018
- First submitted
- 24 Jan 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26498468
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Compression Wear on Whole-body Electromyostimulation and Exercise-induced Muscle Soreness. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03417323
- Acronym / sponsor ID
- COMDOME / Compression_DOMS_EMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- German Sport University, Cologne
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive garment | Experimental | Other: CompressionGroups wear compression garment after WB-EMS induced muscle soreness |
| No compression garment | No intervention | –Groups wear no compression garment after WB-EMS induced muscle soreness |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy athletes with >5 years of experience in competition balls sports and corresponding discipline specific resistance exercise
Key exclusion criteria (2 listed)
- diseases and medication affecting muscle metabolism
- contraindication for WB-EMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CompressionParticipants 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. | Other | Compressive garment |
Primary outcome
Maximum isokinetic leg extensor strength
Time frame: 5 days
Changes of isokinetic leg extensor strength during the intervention period
5 secondary outcomes
Perceived physical state
Time frame: 5 days
Resting metabolic rate
Time frame: 5 days
Myoglobin
Time frame: 5 days
Heart rate variability
Time frame: 5 days
creatine-kinase (CK) concentration
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 26498468Kemmler 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.
- Institution homepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Lötzerich, PhD study chair
German Sport University, Cologne
Wolfgang Kemmler, PhD principal investigator
University of Erlangen-Nürnberg Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression in people with Muscular Regeneration and Repeated Bout Effect of WB-EMS, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum isokinetic leg extensor strength (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.