- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07299669
Effects of BEMER Electromagnetic Field Intervention on Sleep, Readiness to Play and Injuries in Elite Athletes (BEMER-sport)
The Effect of Bio-electromagnetic-energy-regulation Therapy (BEMER) on Sleep, Readiness to Play and Injuries in Elite Athletes - a Triple Blinded Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Contrary to common assumptions, athletes often experience insufficient sleep, particularly in the context of competitive events. Furthermore, a significant proportion of athletes report poor sleep quality, potentially linked to frequent travel, intense training, suboptimal training times and inadequate caloric intake. Female athletes are especially susceptible, facing additional challenges such as role conflicts, gender discrimination, body image concerns, increased risk of eating disturbances, and negative impact from menstruation, all of which may hinder restitution. A promising intervention to enhance and facilitate restitution involves the use of low frequency pulsed electromagnetic field (PEMF) therapy, which has demonstrated the potential to increase blood flow, particularly in micro vessels, and is as such assumed to increase micro-circulation, among other in the skeleton muscles. The effectiveness of PEMF therapy in athletes has so far not been investigated using a randomized controlled design.
In this study, a triple blind (participants, researchers and statistician) randomized controlled trial will be undertaken, with female athletes (N=60) from national (Norway) football teams being randomly designed to receive either a placebo mattress or a PEMF-mattress based on a 1:1 ratio, using stratified randomization by team. During a baseline assessment period of 4 weeks, 3 primary outcomes (radar assessed total sleep time and sleep efficiency), and readiness to play (composite measure of daily self-report of fatigue, sleep quality, muscle soreness, stress and mood) will be recorded at a daily basis. These 3 outcomes will be analyzed also specifically for the day/night following matches (as secondary outcomes). Other secondary outcomes comprise the amount (duration) of slow wave sleep/deep, assessed with the sleep radar technology, the severity of injuries, and the rate of perceived exertion (RPE) following training and matches.
The participants (N=60) will following the 4-week baseline registration commence a 10 week intervention phase involving daily use of the mattress for 2 (morning and evening) x 8 minutes. The system has 3 levels of PEMF-intensity (low, medium, high). The first four weeks the low intensity will be used, the next two the medium intensity will be used, thereafter (last four weeks) the high intensity will be used. This intervention period will be accompanied by reassessment of the primary and secondary outcomes during the last 4 weeks of the 10-week intervention period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bergen, Norway
- Bergensregionen
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Oslo, Norway
- Osloregionen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum 18 years of age
- Female elite football player in Norway
- Playing on team willing to part-take in the study
Exclusion Criteria:
• None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BEMER electromagnetic-energy-regulation therapy
BEMER electromagnetic mattress; week 1-4 at low lever, week 5-6 medium level and week 7-10 high level
|
The BEMER is bio-electric-magnetics-energy-regulation therapy uses a specific waveform of pulsed electromagnetic field (PEMF) to improve microcirculation by 30%.
In the present study the bio-electric-magnetics-energy-regulation therapy will be provided through mattresses
Other Names:
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Sham Comparator: Sham-mattress
Mattress and interface panel similar to the experimental intervention, but without any electromagnetic output signals
|
Sham mattress with no electromagnetic output
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total sleep time
Time Frame: Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
|
Total sleep time in the main sleep episode assessed with the sleep radar Somnofy, expressed as minutes per day.
High total sleep time is regarded as a more positive outcome than a lower total sleep time.
|
Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
|
|
Sleep efficiency
Time Frame: Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
Percentage of time in bed following shut-eye (lights out) to rising from bed where the participant did sleep - assessed with the sleep radar Somnofy during the main sleep period.
The measure comprises the percentage of time being asleep, and higher values (percentage) are regarded as a better outcome than lower values (percentage).
|
Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
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Readiness to play
Time Frame: Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
Daily morning self-report on an adapted version of the Hooper Index (Hooper, Mackinnon, Howard, Gordon, & Bachmann, 1995), comprising four items assessing fatigue, sleep quality, muscle soreness, and stress.
Each item is rated on a 7-point scale ranging from 1 to 7 (where 7 is the worst state and 1 is the best state).
A composite daily score ranging from 4 to 28 is calculated - lower scores are associated with the best outcomes.
|
Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total sleep time the day following matches
Time Frame: Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention exclusively on the nights after matches.
|
Total sleep time in the main sleep episode assessed with the sleep radar Somnofy the day following matches, expressed as minutes per day.
High total sleep time is regarded as a more positive outcome than a lower total sleep time.
|
Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention exclusively on the nights after matches.
|
|
Sleep efficiency the day following matches
Time Frame: Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention exclusively the night following matches.
|
Percentage of time in bed following shut-eye (lights out) to rising from bed where the participant did sleep assessed with the sleep radar Somnofy during the main sleep period - the day following matches.
The measure comprises the percentage of time being asleep, and higher values (percentage) are regarded as a better outcome than lower values (percentage).
|
Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention exclusively the night following matches.
|
|
Deep sleep duration
Time Frame: Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
Deep sleep duration assessed with the sleep radar Somnofy during the main sleep period, expressed in minutes.
Higher values are regarded as better outcomes than lower values
|
Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention
|
|
Rate of perceived exertion
Time Frame: Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
|
Rate of Perceived Exertion (RPE) following training and matches as measured by a single item based on the Borg CR-10 scale (Borg, 1990).
The response alternatives ranges from 0 (no exertion) to 10 (maximal exertion).
Lower values are regarded as better outcomes than higher values.
|
Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
|
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Readiness to play the day after matches
Time Frame: Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention, exclusively on the day after matches.
|
Daily morning self-report on an adapted version of the Hooper Index (Hooper, Mackinnon, Howard, Gordon, & Bachmann, 1995), comprising four items assessing fatigue, sleep quality, muscle soreness, and stress.
Each item is rated on a 7-point scale ranging from 1 to 7 (where 7 is the worst state and 1 is the best state).
A composite daily score ranging from 4 to 28 is calculated - lower scores are associated with the best outcomes.
|
Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention, exclusively on the day after matches.
|
|
Health problems
Time Frame: Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
|
Health problems are assessed with the Oslo Sports Trauma Research Center Questionnaire on Health Problems-2.
The questionnaire has four items (degree of health problem impact on: 1) participation in training, 2) modification of training, 3) performance, and 4) pain).
All items have four response alternatives and each is scored 0-8-17-25.
A composite score ranging from 0-100 is calculated - higher numbers reflect higher health problem severity.
The instrument will be administered once per week.
|
Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ståle Pallesen, PhD, University of Bergen
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeSCN 25/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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