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To observe comprehensive physical therapy program for OSAHS patients
This study proposes to conduct a randomized controlled trial ,using an APP and wearable devices to provide comprehensive physical therapy and monitoring for people with moderate to severe OSAHS,to assess the effectiveness and adherence of different physiotherapy programs for patients with moderate-to-severe OSAHS by observing the improvement of sleep apnea hypoventilation index (AHI), nocturnal minimum oxygen saturation (Low SpO2), mean oxygen saturation (Mean SpO2), and other health outcomes in the study population. It is expected to explore a clinical treatment pathway suitable for patients with moderate-to-severe OSAHS through mobile app and comprehensive physical therapy, improve the treatment adherence of OSAHS patients, enhance the level of health management services in hospitals, and obtain more physical health and health economic benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Subjects in the control group will receive usual care(On-site healthy lifestyle promotion) | |
| Physical therapy group | Experimental | Subjects in the physical therapy group will receive myofunctional therapy and inspiratory muscle training |
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| Combined Exercise Group | Experimental | Subjects in the combined exercise group will receive myofunctional therapy ,inspiratory muscle training and aerobic training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofunctional Therapy | Behavioral | Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea-hypopnea index(AHI) | The home sleep apnea test (HSAT) device was used to detect the AHI of OSAHS patients, and the AHI was defined as the average number of apneas or hypoventilation per hour during sleep. According to the guidelines and related literature grouping,AHI ≥ 5 times/h was diagnosed as OSAHS, 5 times/h ≤ AHI < 15 times/h as mild OSAHS, and AHI ≥ 15 times/h as moderate to severe OSAHS. Our study observe the changes in apnea-hypopnea index from baseline to 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum oxygen saturation at night(Low SpO2) | The home sleep apnea test (HSAT) device was used to detect the Low SpO2 of OSAHS patients. Our study observe the changes in Low SpO2 from baseline to 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen uptake | Our study observe the changes in cardiorespiratory function from baseline to 3 months.In this program, a cycling graded incremental exercise program (Ramp program) was used, peak oxygen uptake was monitored. | 3 months |
| Sleep quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Wu | Contact | 010-88398069 | wuyifan1127@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xue Feng | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
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| Inspiratory Muscle Training | Behavioral | Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure. |
|
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| Aerobic Exercise | Behavioral | Exercise intensity :40%-60% HRmax , 3-5 days/week |
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Changes in sleep quality from baseline to 3 months. The sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) .The scoring criteria are: 0-5 for very good sleep quality, 6-10 for okay sleep quality, 11-15 for average sleep quality, and 16-21 for very poor sleep quality, with higher total scores indicating poorer sleep quality;
| 3 months |
| Body composition | Changes in body composition analysis from baseline to 3 months.Using bioelectrical impedance analysis to monitor body weight,weight and height will be combined to report BMI in kg/m^2. | 3 months |
| Quality of life score | Changes in quality of life from baseline to 3 months.Quality of life was assessed using the short form 36 questionnaire (SF-36).The score is 0-100, with higher scores indicating higher quality of patient survival. | 3 months |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020247 | Myofunctional Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D003813 | Dentistry |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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