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Effect of Inspiratory Muscle Training (MARITSA)

Primary Purpose

Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Elderly, Inspiratory training

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Intervention: Exercises wih load Device: "Powerbreathe"

Control: Exercises without load

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 23, 2017
Last Updated
June 15, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03190850
Brief Title
Effect of Inspiratory Muscle Training
Acronym
MARITSA
Official Title
Effect of Inspiratory Muscle Training in Sleep Apnea of Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
March 9, 2018 (Anticipated)
Study Completion Date
May 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep Apnea, Elderly, Inspiratory training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator will not know the final result of the tests performed until the end of the study
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention: Exercises wih load Device: "Powerbreathe"
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control: Exercises without load
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The device in which the breathing exercises will be performed will not be adjusted with progressive loading.
Primary Outcome Measure Information:
Title
Effect of inspiratory exercise on apnea-hypopnea index in elderly patients with sleep apnea.
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Effect of inspiratory training on maximal inspiratory and expiratory pressures
Description
Impact of training muscle inspiratory on muscle strength inspiratory and expiratory measured through manovacuometry. The measurement will be taken before and after the training
Time Frame
8 weeks
Title
Effect of inspiratory muscle training on diaphragm thickness
Description
Impact of training muscle inspiratory on diaphragm thickness measured through diaphragmatic ultrasound. The measurement will be taken before and after the training.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Martinez
Email
dm@ufrgs.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Martinez
Organizational Affiliation
PhD of Graduate Program in Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Márcia K Fischer
Phone
+55(51)998587769
Email
mkraidef@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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