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The purpose of this study is to evaluate the feasibility and effects of a 12-week high-intensity progressive Inspiratory Muscle Training (IMT) program in individuals with Class III obesity (BMI ≥ 40 kg/m²) and obstructive sleep apnea (OSA). Using a single-case experimental design (SCED) with multiple baselines, the study will investigate whether this respiratory intervention can reduce the severity of sleep apnea, as measured by the Apnea-Hypopnea Index (AHI), and improve inspiratory muscle strength and sleep quality. Participants will perform daily training sessions using a resistive loading device (POWERbreathe), with intensity progressing from 40% to 90% of their maximum inspiratory pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: High-Intensity IMT | Experimental | Participants will undergo a progressive high-intensity Inspiratory Muscle Training (IMT) program using a resistive loading device (POWERbreathe). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Progressive Inspiratory Muscle Training (IMT) | Device | "The intervention consists of 12 weeks of inspiratory muscle training performed 5 days per week. Each session includes 30 breaths through a resistive loading device (POWERbreathe). The training intensity starts at 40% of the Maximum Inspiratory Pressure (MIP) and progressively increases to 90% of MIP. Training load is adjusted weekly based on new MIP measurements to ensure high-intensity stimulus. Compliance and adverse events will be monitored through a training diary." |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III) | Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Inspiratory Pressure (MIP) | Assessment of inspiratory muscle strength using a digital pressure manometer. | Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks). |
| Epworth Sleepiness Scale (ESS) score |
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Inclusion Criteria: -Adults (≥18 years).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karina Abreu, MSc | Contact | +55 (48) 998230417 | fisioterapeutakarina.abreu@gmail.com | |
| Darlan Laurício Matte, PhD | Contact | +55 48 3364 8696 | darlan.matte@udesc.br |
| Name | Affiliation | Role |
|---|---|---|
| Darlan Laurício Matte, PhD | Santa Catarina State University (UDESC) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Catarina State University - CEFID (Center of Health and Sport Sciences) | Florianópolis | Santa Catarina | 88080-350 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | GRANVILE, A. A. B. B.; BORGES, A. C. L.; RUAS, G. EFEITOS DO TREINAMENTO DE ALTA E BAIXA INTENSIDADE NA MUSCULATURA INSPIRATÓRIA EM INDIVÍDUOS OBESOS MÓRBIDOS: ESTUDO RANDOMIZADO CONTROLADO. Revista Brasileira de Obesidade, Nutrição e Emagrecimento, p. 469-478, dez. 2017. | ||
| 36419804 | Background | Dar JA, Mujaddadi A, Moiz JA. Effects of inspiratory muscle training in patients with obstructive sleep apnoea syndrome: a systematic review and meta-analysis. Sleep Sci. 2022 Oct-Dec;15(4):480-489. doi: 10.5935/1984-0063.20220081. |
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This study utilizes a prospective, non-concurrent multiple-baseline single-case experimental design (SCED) with stability-based phase transition. The protocol is divided into Phase A (Baseline) and Phase B (Intervention), where the start of the high-intensity inspiratory muscle training is determined by the stability of the primary outcomes during the baseline period.
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|
Validated questionnaire to assess the level of daytime sleepiness. Scores range from 0 to 24, where higher scores indicate greater sleepiness.
| Baseline and Post-Intervention (12th week). |
| Pittsburgh Sleep Quality Index (PSQI) global score | Questionnaire to assess sleep quality over a one-month period. Scores range from 0 to 21; higher scores indicate poorer sleep quality. | Baseline and Post-Intervention (12th week). |
| International Physical Activity Questionnaire (IPAQ) - Short Form | Assessment of physical activity level. It classifies participants as sedentary, irregularly active, active, or very active based on metabolic equivalent task (MET-min/week). | Baseline and Post-Intervention (12th week). |
| Borg Rating of Perceived Exertion (RPE) | Scale ranging from 6 to 20 used to monitor the intensity of the respiratory effort during the IMT sessions. | Daily during the 12 weeks of intervention (Phase B). |
| Quebec Sleep Questionnaire (QSQ) | A disease-specific quality of life questionnaire for obstructive sleep apnea. It consists of 32 items divided into five domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions. Each item is scored on a 7-point Likert scale, where higher scores indicate better quality of life. | Baseline (Phase A) and Post-Intervention (12th week of Phase B). |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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