Effects of whole-body pulsed electromagnetic field therapy (type BEMER) on peripheral and central oxygenation at rest and on recovery after exhaustion on a cycle ergometer in recreational endurance athletes
Organizational Data
- DRKS-ID:
- DRKS00034835
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2024-12-20
- Last update in DRKS:
- 2025-02-10
- Registration type:
- Prospective
Acronym/abbreviation of the study
BEMER
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
To ensure continuous high physical and cognitive performance, a balance between stress and recovery must be established (Kellmann, 2001). One promising passive recovery strategy is low-frequency pulsed magnetic field (PEMF) therapy (Markov, 2007). PEMF whole-body mats provide more homogeneous exposure and are used to treat various orthopedic and neurologic conditions (Fischer et al., 2005; Sutbeyaz et al., 2006). However, studies confirming the acute or chronic effects of whole-body PEMF therapy are lacking (Hug & Röösli, 2012), especially with regard to sports and recovery. To date, Jeon et al. (2015) and Rasmussen et al. (2012), for example, have investigated the effects of PEMF therapy on perceived muscle discomfort, Grote et al. (2007) on the autonomic nervous system and well-being, while Tamulevicius et al. (2021) have examined its influence on sleep quality in healthy athletic populations. The results of these studies are contradictory. Therefore, a comprehensive understanding of the underlying physiological effects of PEMF stimulation remains incomplete. Accordingly, the first aim of this study is to investigate whether there is a change in microvascular function and heart rate variability (HRV) at rest before and after 8 minutes of whole-body PEMF stimulation (BEMER type). The microvascular function will be measured using muscular near-infrared spectroscopy in healthy recreational endurance athletes. The second aim is to examine the influence of 8 minutes of PEMF stimulation (BEMER type) on muscular recovery after an exhaustive step protocol on a cycle ergometer in recreational endurance athletes. To gain a more comprehensive understanding of exhaustion from the cycling protocol and passive recovery from PEMF application, several other secondary outcomes will also be recorded. First, blood lactate concentration will be measured as an established marker of passive and active recovery methods to better understand metabolic processes (Dupont et al., 2003; Mota et al., 2017). Secondly, lower limb fatigue and recovery is assessed by Abalakov jumps (Rodríguez-Rosell et al., 2017). Since it is known that physical exhaustion has an influence on cognition and, conversely, cognitive performance has an influence on physical performance, stress and recovery in this study will also be assessed via cognitive tests (executive functions) and via the change in oxygen supply in the prefrontal cortex (Robertson & Marino, 2016). Finally, perceived fatigue and recovery are assessed using 'the Short Recovery and Stress Scale' (German Version: Kurzfragebogen für Erholung und Belastung – KEB) (Kellmann & Kölling, 2020).
Health condition or problem studied
- Free text:
- Passive regeneration method in recreational endurance athletes
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Application of the pulsed electromagnetic field therapy whole-body mat once at rest (day 1) and once as a passive regeneration measure after exertion (day 2) for 8 minutes each.
- Arm 2:
- Control group with the placebo whole-body mat
Endpoints
- Primary outcome:
- - Change in muscular oxy- and deoxyhaemoglobin concentration - Heart rate variability
- Secondary outcome:
- - Executive functions - Change in prefrontal cortex oxy- and deoxyhaemoglobin concentration - Blood lactate concentration - Heart rate - Blood pressure - Skinfold thickness - Jumping height - 'The Short Recovery and Stress Scale' (German Version: Kurzfragebogen für Erholung und Belastung)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Participant draws group affiliation from envelope before starting measurement
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Universität Hamburg Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2025-01-06
- Actual study start date:
- 2025-01-06
- Planned study completion date:
- 2025-08-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 20 Years
- Maximum Age:
- 39 Years
- Additional Inclusion Criteria:
- - At least 3 Watt per kilogram body weight (men) and 2,5 Watt per kilogram body weight (women) on the cycling ergometer (Berrisch-Rahmel et al., 2020) - 30-34 years old: Watt = 3 * body weight (kg) * (130-age)/100 (men) and Watt = 2,5 * body weight (kg) * (124-0,8 * age)/100 (women) (Berrisch-Rahmel et al., 2020)
Exclusion Criteria
- cardiovascular, neurological or orthopedic diseases - acute orthopaedic injuries - relevant visual impairments - significant skin pigmentation - pregnancy
Addresses
Primary Sponsor
- Address:
- Institut für Sport- und Bewegungsmedizin, Universität HamburgTurmweg 220148 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Hamburg, Institute of Human Movement Science, Department of Sports and Exercise MedicineDr. rer. medic. Kim-Charline BroscheidTurmweg 220148 HamburgGermany
- Telephone:
- +4915772160579
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universität Hamburg, Institute of Human Movement Science, Department of Sports and Exercise MedicineDr. rer. medic. Kim-Charline BroscheidTurmweg 220148 HamburgGermany
- Telephone:
- +4915772160579
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universität Hamburg, Institute of Human Movement Science, Department of Sports and Exercise MedicineDr. rer. medic. Kim-Charline BroscheidTurmweg 220148 HamburgGermany
- Telephone:
- +4915772160579
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- BEMER Int. AGAustrasse 159495 TriesenLiechtenstein
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Local Ethics Committee, Faculty of Psychology and Movement Science, University of HamburgVon-Melle-Park 520146 HamburgGermany
- Telephone:
- +49 0000000
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.pb.uni-hamburg.de/en/ueber-die-fakultaet/institutsgremien/lokale-ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2024-07-01
- Ethics committee number:
- 2024_034
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-11-26
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- After completion of all measurements, all mentioned data are anonymized and stored on the MicroFocus drive on a server in the data center of the University of Hamburg for a period of 10 years. Accordingly, all of the individual participant data collected during the trial can be shared after deidentification. The same applies to all other study documents such as the study protocol, the statistics and the declaration of consent.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry