High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Intensity Progressive Inspiratory Muscle Training (IMT).
- Who it may be relevant to
- Registry conditions: Obesity, Class III, Sleep Apnea, Obstructive, Inspiratory Muscle Training. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea: Study Protocol for a Prospective Nonconcurrent Multiple-Baseline Single-Case Experimental Design With Stability-Based Phase Transition
Overview
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
- Device High-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."
Primary outcome measures
- Apnea-Hypopnea Index (AHI) [Time frame: Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).]
Secondary outcome measures (6)
- Maximum Inspiratory Pressure (MIP) [Time frame: Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks).]
- Epworth Sleepiness Scale (ESS) score [Time frame: Baseline and Post-Intervention (12th week).]
- Pittsburgh Sleep Quality Index (PSQI) global score [Time frame: Baseline and Post-Intervention (12th week).]
- International Physical Activity Questionnaire (IPAQ) - Short Form [Time frame: Baseline and Post-Intervention (12th week).]
- Borg Rating of Perceived Exertion (RPE) [Time frame: Daily during the 12 weeks of intervention (Phase B).]
- Quebec Sleep Questionnaire (QSQ) [Time frame: Baseline (Phase A) and Post-Intervention (12th week of Phase B).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Santa Catarina State University - CEFID (Center of Health and Sport Sciences) — Florianópolis
Publications
- 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.
- 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. PMID 36419804
Identifiers
NCT: NCT07469280 · CAAE86299625.1.0000.0118