Effect of Inspiratory Muscle Training

NCT ID: NCT03190850

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-05
• Study Completion Date: 2018-05-10

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Intervention: Exercises wih load Device: "Powerbreathe"

Group Type: EXPERIMENTAL

Intervention

Intervention Type: OTHER

The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength

Control

Control: Exercises without load

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

The device in which the breathing exercises will be performed will not be adjusted with progressive loading.

Interventions

Intervention

The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength

Intervention Type: OTHER

Control

The device in which the breathing exercises will be performed will not be adjusted with progressive loading.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Martinez

Role: STUDY_DIRECTOR

PhD of Graduate Program in Medical Sciences

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Denis Martinez

Role: CONTACT

dm@ufrgs.br

Facility Contacts

Márcia K Fischer

Role: primary

mkraidef@gmail.com

+55(51)998587769

Other Identifiers

150276

Identifier Type: -

Identifier Source: org_study_id