Inspiratory Muscle Training, Obesity, Class III, Sleep Apnea, Obstructive
Conditions
Keywords
Class III obesity, Inspiratory muscle training, Obstructive sleep apnea, Single-case experimental design
Brief summary
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.
Interventions
DEVICEHigh-Intensity Progressive Inspiratory Muscle Training (IMT)
"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."
Sponsors
University of the State of Santa Catarina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Adults (≥18 years). * Of both genders. * Class III obesity (BMI \> 40 kg/m²). * Diagnosis of OSA. * Without neurological conditions that would prevent them from responding to the study assessments.
Exclusion criteria
* Systemic diseases (pulmonary, cardiac or renal). * Are using medications that may affect muscle performance. * Are currently using CPAP therapy. * Conditions that could compromise adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week). | Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Inspiratory Pressure (MIP) | Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks). | Assessment of inspiratory muscle strength using a digital pressure manometer. |
| Epworth Sleepiness Scale (ESS) score | Baseline and Post-Intervention (12th week). | Validated questionnaire to assess the level of daytime sleepiness. Scores range from 0 to 24, where higher scores indicate greater sleepiness. |
| Pittsburgh Sleep Quality Index (PSQI) global score | Baseline and Post-Intervention (12th week). | Questionnaire to assess sleep quality over a one-month period. Scores range from 0 to 21; higher scores indicate poorer sleep quality. |
| International Physical Activity Questionnaire (IPAQ) - Short Form | Baseline and Post-Intervention (12th week). | Assessment of physical activity level. It classifies participants as sedentary, irregularly active, active, or very active based on metabolic equivalent task (MET-min/week). |
| Borg Rating of Perceived Exertion (RPE) | Daily during the 12 weeks of intervention (Phase B). | Scale ranging from 6 to 20 used to monitor the intensity of the respiratory effort during the IMT sessions. |
| Quebec Sleep Questionnaire (QSQ) | Baseline (Phase A) and Post-Intervention (12th week of Phase B). | 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. |
Countries
Brazil
Contacts
CONTACTKarina Abreu, MSc
CONTACTDarlan Laurício Matte, PhD
STUDY_CHAIRDarlan Laurício Matte, PhD
Santa Catarina State University (UDESC)
Outcome results
None listed