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

NCT05311280 | Unknown DMC

• 1 other identifier: TYGH109058
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Myotherapy; High intensity interval training

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• oxygen desaturation index (ODI)

  change from baseline oxygen desaturation index for 2 month

• BMI

  change from baseline BMI for 2 month

Study Arms (2)

high intensity interval training plus myotherapy

EXPERIMENTAL

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

home exercise training plus myotherapy

ACTIVE COMPARATOR

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

Interventions

high intensity interval training plus myotherapy OTHER

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.

high intensity interval training plus myotherapy

home exercise plus myotherapy OTHER

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.

home exercise training plus myotherapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis as OSA by ENT
• AHI 5\~30 (mild to moderate OSA)
• BMI \>24
• Body fat male\>20% female\>30%
• age from 20\~80

You may not qualify if:

• Rest BP \< 160/100
• Unstable cardiopulmonary disease
• CPAP use
• mandibular advancement
• Cancer
• BMI \> 40
• unable to speak Chinese or English

Sponsors & Collaborators

• Taoyuan General Hospital: lead

Study Sites (1)

Taoyaun General Hospital, Ministry of Wealth and Health

Taoyuan District, Taoyuan Dist., 330, Taiwan

Location

Related Publications (25)

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  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: intervention group: Myotherapy+High intensity interval training Control group: Myotherapy + general home exercise

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: April 5, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

TW (1)