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The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program.
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. The gold standard treatment for OSA is the use of Positive Airway Pressure, but due to the low adherence to this resource, the multidisciplinary approach for the treatment of OSA is becoming the best therapeutic option. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
Aims:The primary objective of this study is to identify the effects of IMT on the severity of OSA in indivuals after stroke participating in a rehabilitation program. The secondary objectives are to identify effects of IMT on sleep quality and daytime sleepiness and analyze the correlation between severity of OSA and functional independence, inspiratory endurance and pressure.
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Experimental Group: Inspiratory Muscle Training + rehabilitation program |
|
| Control Group | Other | Control Group: rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training | Other | The Experimental Group will perform IMT which includes training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. They will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA. |
| Measure | Description | Time Frame |
|---|---|---|
| OSA severity | OSA severity measured using the Apnea/Hypopnea Index (AHI) | 5 weeks (immediately post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| inspiratory muscle endurance | inspiratory muscle endurance measured through the incremental endurance test | 5 weeks (immediately post intervention) |
| inspiratory muscular strength | inspiratory muscular strength measured through inspiratory pressures |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lorena de Oliveira Vaz | Salvador | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37103682 | Derived | de Oliveira Vaz L, Galvao AP, Nunes DLM, de Almeida JC, de Fatima Garcia Diniz J, Oliveira-Filho J. Effects of inspiratory muscle training on the severity of obstructive sleep apnea in individuals after stroke: a protocol for a randomized controlled trial. Sleep Breath. 2023 Dec;27(6):2257-2263. doi: 10.1007/s11325-023-02825-0. Epub 2023 Apr 27. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Control | Other | The control group will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA. |
|
| 5 weeks (immediately post intervention) |
| sleep quality | sleep quality measered through Pittisburgh Sleep Quality Index | 1 month post intervention |
| daytime sleepiness | daytime sleepiness measered through Epworth Sleepiness Scale | 1 month post intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |