The Effect of High Intensity Interval Exercise and Myofunctional Therapy on Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) is a sleep disorder which is caused because of collapse of airway or inappropriate tongue position. As OSA becomes severe, the physical and psychological aspect might be influenced due to insomnia. In addition, many evidences revealed that OSA is related to cardiovascular disorder. Apnea-hypopnea index (AHI) and epworth sleepiness scale (ESS) are common parameters to evaluate the severity of OSA. Recently, body and tongue fat have certain relation with OSA, and the higher the fat, the more possible to get OSA. To find the treatments for OSA, myotherapy has been proved to improve AHI and ESS. The treat mechanism is speculated that increasing muscle tone around oral and oropharyngeal and decreasing tongue fat. High intensity interval training (HIIT) might be effective to OSA, for it could lower down the total body fat. Furthermore, HIIT is a time-efficient program which can increase exercise adherence. Last, less articles discussed about the effect of supervised verse unsupervised treatment and the effect of mix-model treatment. The purpose of the study is investigating the comparison between supervised HIIT plus myotherapy and unsupervised home exercise plus myotherapy. Method: 40 patients who meets the inclusion criteria will be recruited in this article during 2022/01 to 2022/12. Then, they will be randomly assigned into HIIT plus myotherapy group and home exercise plus myotherapy group. The treatment process will last for 8 weeks. All the outcomes such as AHI,ESS and body fat will be completed before and after 8 weeks treatment. The Wilcox signed test was adopted to analyze the treatment before and after the treatment sessions (time effect). The Mann-Whitney U was applied for the difference before and after treatment between two groups (group effect), and the baseline of two groups was also analyzed by this method. The significant level was set as p value< 0.05. Hypothesis: It is speculated that HIIT plus myotherapy might revealed better outcomes on AHI, ESS, and body fat.

Detailed Description
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introduction Obstructive sleep apnea (OSA) is a sleep disorder that is characterized by apneas and hypopneas during sleep due to repetitive collapse of the upper airway. The prevalence is 3-7% in men and 2-5% in women. Daytime sleepiness and insomnia are associated with both decreased physical activity and increased obesity, increased OSA severity is also associated with decreased physical activity, resulting in a vicious cycle. Accumulating evidence shows that OSA is associated with multiple cardiovascular disorders, such as hypertension, type 2 diabetes mellitus and coronary artery disease. The treatment of OSA may reduce the risk of these cardiovascular disorders. The apnea-hypopnea index (AHI) has been widely used to quantify the level of OSA by the number of apnea episodes per hour. Based on the definition of American Academy of Sleep Medicine (AASM) and an article about epidemiology of OSA, AHI range from 5 15 is defined as mild OSA, and AHI 15 30 is defined as moderate OSA. AHI over 30 can be regarded as severe OSA. Epworth sleepiness scale (ESS) is a questionnaire to measure subject general level of daytime sleepiness. OSA patients often revealed higher score which refers to higher possibility to get sleep disorder. Recently, some articles showed that body and tongue fat deposition have certain relation with OSA, the higher the fat, the more possible to get OSA. Body fat can be quantified through waist and neck circumference. In order to solve OSA, myotherapy (MT) might be an effective method. MT is composed of isotonic and isometric exercise related to oral, oropharyngeal, and respiratory exercise. Based on previous review and meta-analysis, MT can decrease not only AHI score, but also ESS score. It means that MT is beneficial to release the symptom of sudden apnea and hypopneas through decreasing the amount of fatty deposition of the tongue and increasing oral and oropharyngeal muscle tone. Recent article also supports that weight and fat loss of soft tissue of tongue is important for treat OSA[12]. Some articles also mentioned that the snoring situation during sleep time has declined. That is, the sleep interruption to people sleeping beside the OSA patient are alleviated. In addition, the sleep and life quality can be ameliorated by myotherapy. Inconsistent evidence also manifested that oxygen saturation has been improved after myotherapy. In short, MT can be regarded as optimal alternative therapy to mild to moderate OSA patient. Exercise training is an effective intervention in reducing the severity of OSA and improving symptoms of sleepiness and quality of life. According to previous systematic review and meta-analysis, exercise such as aerobic exercise and resistance exercise has been proved effective on improving AHI, ESS. However, these articles didn't focus on body fat that is highly associated with OSA. According to recent article, decreasing body fat is essential to deal with OSA. Hence, high intensity interval training (HIIT) has been proved its same effect on lower down body fat as moderate intensity continuous training (MICT). HIIT also shows greater effectiveness compared with (MICT) on cardiovascular and metabolic function in both healthy populations and populations with cardiovascular disease. In addition, HIIT has the additional benefit of being a time-efficient program which can increase exercise adherence and the participants were more likely to intend to continue. Previous two studies show that HIIT could improve the severity of OSA in both obese adults and obese children, but it still needs evidence to prove the effectiveness among different aspects. According to recent literature review, there is no standard physical therapy model for OSA. Furthermore, less articles discussed about the effect of supervised verse unsupervised treatment and the effect of mix-model treatment. Hence, the purpose of the study is investigating the comparison between supervised HIIT plus myotherapy and unsupervised home exercise plus myotherapy. It is hypothesized that HIIT plus myotherapy might revealed better outcomes on AHI, ESS, and body fat. Method Procedure The subjects included in this study were randomized assigned to experimental group and control group. The randomization orders were decided by computer, and all the contents were concealed into a dark color envelop. Before first treatment, the envelops were opened to determine which treatment protocol were adopted. The treatment of experimental group was composed of myotherapy and resistance exercise plus high intensity interval training (HIIT). The treatment of control group was composed of general stretch exercise plus myotherapy. Subsequently, initial measurement was conducted including BMI, Body fat, waist and neck circumstanced, apnea hypopnea index (AHI), Epworth Sleepiness Scale (ESS), oxygen desaturation index (ODI) and body fat. Then, the treatment protocols were both executed for 30 minutes, sixteen times in two months. After completing the treatment process, the final measurement was conducted as the initial treatment. All the outcomes were collected and analyzed by statistically method. Treatment Experimental group is composed of myotherapy and high intensity interval training (HIIT) plus resistance exercise. Myotherapy was based on the studies by Lequeux et al. and Cláudia et al. Subjects were instructed to perform tongue slide, tongue force, tongue press, tongue reach, swallowing exercise, smiling exercise, jaw press exercise, chewing exercise, breathing exercise and buccinator exercise. Exercise training would be implemented in the form of high-intensity interval training and resistance exercise. High-intensity interval training intensity of the target heart rate (THR) was calculated as follows: THR = (HRmax - HRrest) × 80-90%Intensity + HRrest. The HIIT program included four 3-min bouts at high-intensity (80-90%HRR), separated by 3-min of active recovery and total for 4 cycles of 24-min HIIT intervention. The HIIT exercise options were running on a treadmill. Polar heart rate monitors were used to monitor exercise intensity. Subsequently, the 20-min resistance exercise program was conducted using a theraband. The different colors of band indicate different levels of resistance. The four limbs were mainly exercised with yellow, red, green and blue colored elastic bands. In this regard, the theraband was color-coded in the following order of increasing resistance: blue, green, blue and dark. Each subject began the program using the blue theraband. As the subjects performed the ability to complete 15 repetitions without difficulty, the intensity of the thraband was progressed. The volume of the resistance was 10 repetitions per set, and 3 set in a training session. Exercises included shoulder press, shoulder lateral raise, biceps curl, butterfly, seat row, leg press(squat), calf raise, latissmus pulldown, abdominal curl and bridge. Five minutes of stretching exercises was conducted as a warm-up and cool down period before and after training sessions. The physiotherapist with abundant experience related to myotherapy and high intensity interval training (HIIT) plus resistance exercise supervised all the treatment process to confirm the quality of execution. This exercise was performed 12 15 repetition depends on patient's condition. Statistical analysis The primary variable of the study were body fat, neck and waist circumstance, AHI, ODI and ESS. The secondary variable of the study were body weight and BMI. Descriptive statistics for the categorical variable were documented as frequency counts and percentages. The continuous variables were reported as mean + SD, if they were normal distribution, or they were recorded as median and range. The Wilcox signed test was adopted to analyze the treatment before and after the treatment sessions (time effect). The Mann-Whitney U was applied for the difference before and after treatment between two groups (group effect), and the baseline of two groups was also analyzed by this method. The significant level was set as p value< 0.05. All the statistical data analysis was performed by SPSS version 22.

Official Title
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The Effect of High Intensity Interval Exercise and Myofunctional Therapy on Obstructive Sleep Apnea: a Randomized Clinical Controlled Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: high intensity interval training plus myotherapy
* Other: home exercise plus myotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis as OSA by ENT AHI 5 30 (mild to moderate OSA) BMI >24 Body fat male>20% female>30% age from 20 80 Exclusion Criteria: Rest BP < 160/100 Unstable cardiopulmonary disease CPAP use mandibular advancement Cancer BMI > 40 unable to speak Chinese or English

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: intervention group: Myotherapy+High intensity interval training Control group: Myotherapy + general home exercise
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high intensity interval training plus myotherapy<br>Subjects were instructed to perform tongue slide, tongue force, tongue press, tongue reach, swallowing exercise, smiling exercise, jaw press exercise, chewing exercise, breathing exercise and buccinator exercise.These myofunctional exercise were performed 10 repetitions for a set, 2 sets in a treatment session depends on patient's condition. Between each session, subjects were allowed to rest at least 1 minutes. Exercise training would be implemented in the form of high-intensity interval training and resistance exercise. High-intensity interval training intensity of the target heart rate (THR) was calculated as follows: THR = (HRmax - HRrest) × 80-90%Intensity + HRrest[26]. The HIIT program included four 3-min bouts at high-intensity (80-90%HRR), separated by 3-min of active recovery and total for 4 cycles of 24-min HIIT intervention. The HIIT exercise options were running on a treadmill. | Other: high intensity interval training plus myotherapy<br>* High intensity interval training (HIIT) has been proved its same effect on lower down body fat as moderate intensity continuous training (MICT). In addition, HIIT has the additional benefit of being a time-efficient program which can increase exercise adherence and the participants were more likely to intend to continue. Previous two studies show that HIIT could improve the severity of OSA in both obese adults and obese children. Myotherapy: MT is composed of isotonic and isometric exercise related to oral, oropharyngeal, and respiratory exercise. Based on previous review and meta-analysis, MT can decrease not only AHI score, but also ESS score. It means that MT is beneficial to release the symptom of sudden apnea and hypopneas.<br>|
| Active Comparator: home exercise training plus myotherapy<br>Subjects were instructed to perform tongue slide, tongue force, tongue press, tongue reach, swallowing exercise, smiling exercise, jaw press exercise, chewing exercise, breathing exercise and buccinator exercise.These myofunctional exercise were performed 10 repetitions for a set, 2 sets in a treatment session depends on patient's condition. Home exercise is composed of ambulation training outside or inside. Three phase including warm up, training phase, and cool down. The intensity of training phase is decided by rating of perceived exertion (RPE) range from 11 15. 2 5 training times a week will involved according to patients' preference. | Other: home exercise plus myotherapy<br>* Home exercise: ambulation by patients themselves Myotherapy: MT is composed of isotonic and isometric exercise related to oral, oropharyngeal, and respiratory exercise. Based on previous review and meta-analysis, MT can decrease not only AHI score, but also ESS score. It means that MT is beneficial to release the symptom of sudden apnea and hypopneas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index (AHI) | The severity of sleep apnea was evaluated by an apnea-hypopnea index (AHI; number of apneas and hypopneas per hour of sleep) according to the data of polysomnography (PSG) in sleep center of TYGH. The average number of desaturation episodes per hour | Change from baseline Apnea-hypopnea index for 2 month | 
| Epworth Sleepiness Scale (ESS) | The excessive daytime sleepiness was measured by Epworth Sleepiness Scale (ESS) | Change from baseline Epworth Sleepiness Scale for 2 month | 
| body fat | Total body fat was evaluated by the weight scale that is correction by Inbody machine with high validity | Change from baseline body fat for 2 month | 
| waist and neck circumstance | he waist and neck circumstance were measured by measuring tape | change from baseline waist and neck circumstance for 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen desaturation index (ODI) | The ODI is measured by an oximeter, which is a device typically placed on the fingertip that shines a red light on the skin and can estimate the amount of oxygen in the peripheral blood. Desaturation episodes are generally described as a decrease in the mean oxygen saturation of ≥4% (over the last 120 seconds) that lasts for at least 10 seconds. The ODI was graded into three groups: mild (5-14), moderate (15-29), and severe (≥30) OSA. Patients with an ODI<5 were graded as having no oxygen disturbance | change from baseline oxygen desaturation index for 2 month | 
| BMI | Total body fat was evaluated by the weight scale that is correction by Inbody machine with high validity. The parameters such as BMI and body fat mass were measured by this test. | change from baseline BMI for 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Myotherapy, High intensity interval training