Effect of Inspiratory Muscle Training (MARITSA)

Effect of Inspiratory Muscle Training in Sleep Apnea of Elderly

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Other: Intervention; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Márcia K Fischer; Phone Number: +55(51)998587769; Email: mkraidef@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention: Exercises wih load Device: "Powerbreathe"	Other: Intervention; The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength
Placebo Comparator: Control; Control: Exercises without load	Other: Control; The device in which the breathing exercises will be performed will not be adjusted with progressive loading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of inspiratory exercise on apnea-hypopnea index in elderly patients with sleep apnea.	Impact of inspiratory muscle training on apnea-hypopnea index in elderly patients with sleep apnea. The measurement will be taken before and after the training. The measurement is apnea-hypopnea index through polysomnograph	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of inspiratory training on maximal inspiratory and expiratory pressures	Impact of training muscle inspiratory on muscle strength inspiratory and expiratory measured through manovacuometry. The measurement will be taken before and after the training	8 weeks
Effect of inspiratory muscle training on diaphragm thickness	Impact of training muscle inspiratory on diaphragm thickness measured through diaphragmatic ultrasound. The measurement will be taken before and after the training.	8 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Denis Martinez, PhD of Graduate Program in Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2016
• Primary Completion (Anticipated): March 9, 2018
• Study Completion (Anticipated): May 10, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Elderly; Sleep Apnea; Inspiratory training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Apnea
• Other Study ID Numbers: 150276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No