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

NCT02584205 | Unknown DMC

• 1 other identifier: 36660314.8.0000.5208
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

inspiratory muscle training; obstructive sleep apnea; functional capacity

Outcome Measures

Primary Outcomes (1)

• Change in maximal oxygen uptake after inspiratory muscle training

  twelve weeks

Study Arms (2)

Powerbreathe

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Powerbreathe DEVICE

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.

Control; Powerbreathe

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Adília Karoline Ferreira Souza

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Adília KF Souza, Mastering

  UFPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adília KF Souza, Mastering

CONTACT

55 81 9564 8415; adiliakaroline@hotmail.com

Adilia KF Souza, Mastering

CONTACT

55 83 9671 8345; adiliakfsfisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: October 22, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

BR (1)