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

Primary Purpose

Sleep Apnea, Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Powerbreathe
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring inspiratory muscle training, obstructive sleep apnea, functional capacity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adília Karoline Ferreira SouzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Powerbreathe

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in maximal oxygen uptake after inspiratory muscle training

Secondary Outcome Measures

Full Information

First Posted
April 8, 2015
Last Updated
October 20, 2015
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02584205
Brief Title
Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea?
Official Title
Does Inspiratory Muscle Training Improve Functional Capacity in Subjects With Obstructive Sleep Apnea? Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
inspiratory muscle training, obstructive sleep apnea, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Powerbreathe
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Powerbreathe
Intervention Description
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 Measure Information:
Title
Change in maximal oxygen uptake after inspiratory muscle training
Time Frame
twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adília KF Souza, Mastering
Phone
55 81 9564 8415
Email
adiliakaroline@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adilia KF Souza, Mastering
Phone
55 83 9671 8345
Email
adiliakfsfisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adília KF Souza, Mastering
Organizational Affiliation
UFPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adília Karoline Ferreira Souza
City
Recife
State/Province
Pernambuco
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adília KF Souza, Mastering
Phone
55 81 9564 8415
Email
adiliakaroline@hotmail.com
First Name & Middle Initial & Last Name & Degree
Adília KF Souza, Mastering
Phone
55 83 9671 8345
Email
adiliakfsfisio@gmail.com

12. IPD Sharing Statement

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

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