Clinical trial NCT03190850: Effect of Inspiratory Muscle Training
Official title: Effect of Inspiratory Muscle Training in Sleep Apnea of Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Sleep Apnea
Elderly
Inspiratory training
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of inspiratory muscle training on sleep apnea in the elderly. The patients screened will be randomized and allocated into two groups, intervention and control. In the intervention group, the patients will perform the exercises with the inspiratory muscular training apparatus called Powerbreathe with progressive load, according to its inspiratory muscular force. The control group will perform the same exercises, with the same apparatus, but without load.

Detailed description: At the beginning of the study the patients will be evaluated initially with polysomnography. Patients who meet the inclusion criteria and sign the consent form will be evaluated with the following exams before and after inspiratory muscle training: manovacuometry, spirometry, diaphragmatic ultrasound and an anthropometric evaluation. After inspiratory muscle training, all patients will also perform polysomnography again to check for apnea-hypopnea index change.The patients screened will be randomized and allocated into two groups, intervention and control. In the intervention group, the patients will perform the exercises with the inspiratory muscular training apparatus called Powerbreathe with progressive load, according to its inspiratory muscular force. The control group will perform the same exercises, with the same apparatus, but without load.Patients in the intervention group will perform inspiratory muscle training as follows: in the first and second weeks, the patients will be instructed to perform the breathing exercises three times a week, performing four sets of six repetitions with one minute rest, with load of 50% of the maximum inspiratory pressure that will be preset in the Powerbreathe device by the study collaborators. At the end of the second week, they will perform reassessment of inspiratory pressures (MIP) and maximal expiratory pressure, with a 75% load adjustment of the PIM in the Powerbreathe device, and the patients being instructed to perform the same series and repetitions with frequency of exercise in five times in the week in the third and fourth week. At the end of the fourth week, they will perform a reassessment of the inspiratory pressures (MIP) and maximal expiratory pressures, with a 75% load adjustment of the MIP in the Powerbreathe device and the patients being instructed to perform the same series and repetitions with frequency of exercise in five times in the week on the fifth and sixth week. At the end of the sixth week, they will perform a reassessment of inspiratory pressures (MIP) and maximal expiratory pressure, with a 80% load adjustment of the MIP in the Powerbreathe device and the patients being instructed to perform the same series and repetitions with frequency of exercise in seven times in the week in the seventh and eighth week. The no-load (control) inspiratory muscle training group will perform the same series, repetitions and frequency of breathing exercises and reassessments of the intervention group, but there will be no load adjustment on the Powerbreathe appliances of this group.

Eligibility criteria: Inclusion Criteria:

* Age between 65 and 80 years
* Both genders
* Not be treating apnea with AHI between 10 and 30
* Do not tolerate or not have access to CPAP with any AHI
* To consent to participate in the research

Exclusion Criteria:

* Treatment for sleep apnea
* Severe chronic illness
* IAH greater than 35
* Uncontrolled arterial hypertension
* Acute myocardial infarction
* Recent upper airway trauma
* High performance athletes
* Medications with effect on the central nervous system

Primary outcomes:
measure: Effect of inspiratory exercise on apnea-hypopnea index in elderly patients with sleep apnea.
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of inspiratory training on maximal inspiratory and expiratory pressures
timeFrame: 8 weeks
measure: Effect of inspiratory muscle training on diaphragm thickness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: PhD of Graduate Program in Medical Sciences
name: Denis Martinez
role: STUDY_DIRECTOR
References: