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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total sleep time
研究概览
简要总结
Elite athletes (female football players) will be randomized to 1 of 2 conditions, comprising a BEMER electromagnet field mattress and a sham-mattress. The mattress is to be used in bed for 8 minutes each morning, and for 8 minutes each evening, for 10 weeks. The system has 3 intensity levels - low, medium, and high. The low level will be used for the 4 first weeks, the medium level for the following 2 weeks, and the high level for the last 4 weeks. Those in the sham conditions have a display and mattress looking identical, and follow the same procedure as those in BEMER electromagnet field mattress condition. The primary outcome comprises total sleep time and sleep efficacy assessed with a sleep radar as well as readiness to play (composite measure of daily self-report of fatigue, sleep quality, muscle soreness, stress and mood). Secondary outcomes comprise duration of deep sleep also assessed with the sleep radar, injury severity, and rate of perceived exertion following training and matches. Baseline registrations are conducted for 4 weeks prior to the intervention and outcomes are registered during the last 4 weeks of the intervention.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Minimum 18 years of age
- •Female elite football player in Norway
- •Playing on team willing to part-take in the study
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: BEMER electromagnetic-energy-regulation therapy (Device)
Sham-mattress
Mattress and interface panel similar to the experimental intervention, but without any electromagnetic output signals
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Total sleep time
时间窗: 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.
Sleep efficiency
时间窗: 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).
Readiness to play
时间窗: 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.
次要结局
- Total sleep time the day following matches(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(Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention exclusively the night following matches.)
- Readiness to play the day after matches(Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention, exclusively on the day after matches.)
- Deep sleep duration(Change from baseline (4 weeks before intervention) to the last 4 weeks of the intervention)
- Health problems(Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.)
- Rate of perceived exertion(Change from baseline (4 weeks before interventions) to the last 4 weeks of the intervention.)
研究者
Ståle Pallesen
Professor
University of Bergen