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Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea?

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ClinicalTrials.gov Identifier: NCT02584205
Recruitment Status : Unknown
Verified October 2015 by Adília Karoline Ferreira Souza, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Adília Karoline Ferreira Souza, Universidade Federal de Pernambuco

Brief Summary:
Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles. Therefore, the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA. A pilot study will be conducted to calculate the sample. Individuals of both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by polysomnography) will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study deals with a test-clinical randomized double-blind.The intervention groups held inspiratory muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will be submitted to a simulated training with load less than 10% of MIP (insufficient charge to train the muscles), during the same period as the intervention group. The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the training period, the groups will be reassessed by the evaluation tests of functional capacity (ADL- Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung function (spirometry) and then compared. Expected results: The interventional groups will improve their functional capacity.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Powerbreathe Not Applicable

Detailed Description:
Introduction: Obstructive sleep apnea (OSA) is a chronic, progressive and disabling disease and can affect functional capacity due to the weakness of the respiratory muscles. The inspiratory muscle training (IMT) has improved exercise tolerance in other cardiopulmonary diseases such as chronic obstructive pulmonary disease and heart failure. Objectives: Therefore, the objective of this study is to evaluate the effect of inspiratory muscle training on functional capacity in patients with OSA. Patients and Methods: A pilot study will be conducted to calculate the sample. Individuals of both genders, diagnosed with obstructive sleep apnea moderate or severe (measured by polysomnography) will be invited and the data collected in the Sleep Laboratory of the Pronto-Socorro Cardiológico de Pernambuco (PROCAPE), located in Recife- PE- BRAZIL. The study deals with a test-clinical randomized double-blind to be held in four groups: A) Patients with OSA and Obesity - intervention, B) Patients with OSA and Obesity - control, C) Patients with OSA eutrophic - intervention , D) Patients with OSA eutrophic - control. The intervention groups held inspiratory muscle training (IMT) and the load is equivalent to 40% of maximal inspiratory pressure (MIP). The evaluations will be performed once a week during twelve weeks. Control groups will be submitted to a simulated training with load less than 10% of MIP (insufficient charge to train the muscles), during the same period as the intervention group. The guidelines for the training and weekly evaluations will be performed by the responsible for the researcher physiotherapist in Cardiopulmonary Physical Therapy Laboratory (LACAP- UFPE). After the training period, the groups will be reassessed by the evaluation tests of functional capacity (ADL-Glittre Test and Ergospirometry), inspiratory muscle strength (manometer) and lung function (spirometry) and then compared. Expected results: The interventional groups will improve their functional capacity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea? Randomized Clinical Trial
Study Start Date : April 2015
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Powerbreathe
We will use the powerbreathe Classic light resistance in this intervention (inspiratory muscle training). Both groups will receive the equipment, but the intervention group will do the training with a load 40% of the maximum inspiratory pressure.
Device: Powerbreathe
In this intervention we will use an equipment called "powerbreathe classic light". It provides us to choose resistance levels with an adjustable load setting range: 1 to 9 and it's ideal for beginners. In this research we will use it on the intervention group to improve the strength of inspiratory muscle training and evaluate the results in the functional capacity of the subjects with obstructive sleep apnea.

Placebo Comparator: Control
This group will also receive the equipment (powerbreathe classic light) but will do the "training" with a load less than 10% of the maximum inspiratory pressure (insufficient charge to train the muscles).
Device: Powerbreathe
In this intervention we will use an equipment called "powerbreathe classic light". It provides us to choose resistance levels with an adjustable load setting range: 1 to 9 and it's ideal for beginners. In this research we will use it on the intervention group to improve the strength of inspiratory muscle training and evaluate the results in the functional capacity of the subjects with obstructive sleep apnea.




Primary Outcome Measures :
  1. Change in maximal oxygen uptake after inspiratory muscle training [ Time Frame: twelve weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with OSA (moderate or severe) diagnosed by polysomnography;
  • Age between 40 and 65;
  • Who are qualified to perform the stress tests to assess functional capacity;
  • Individuals with BMI ≥ 18 ≤ 39.9 kg / m2.

Exclusion Criteria:

  • Patients who are making use of non-invasive ventilation;
  • Patients who report on your medical history, orthopedic problems, neurological or cardiovascular or respiratory disease which may cause limitation of functional capacity;
  • Patients with BMI> 40 kg / m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584205


Contacts
Contact: Adília KF Souza, Mastering 55 81 9564 8415 adiliakaroline@hotmail.com
Contact: Adilia KF Souza, Mastering 55 83 9671 8345 adiliakfsfisio@gmail.com

Locations
Brazil
Adília Karoline Ferreira Souza Recruiting
Recife, Pernambuco, Brazil
Contact: Adília KF Souza, Mastering    55 81 9564 8415    adiliakaroline@hotmail.com   
Contact: Adília KF Souza, Mastering    55 83 9671 8345    adiliakfsfisio@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Principal Investigator: Adília KF Souza, Mastering UFPE

Responsible Party: Adília Karoline Ferreira Souza, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02584205     History of Changes
Other Study ID Numbers: 36660314.8.0000.5208
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Adília Karoline Ferreira Souza, Universidade Federal de Pernambuco:
inspiratory muscle training
obstructive sleep apnea
functional capacity

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes