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Validation and Reproducibility of the Six-minute Step Test in Individuals With Obstructive Sleep Apnea Treated With CPAP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334331
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Matheus Gustavo Silva Magalhães, Universidade Federal de Pernambuco

Brief Summary:
Introduction: The Obstructive Sleep Apnea (OSA) is characterized by obstructed superior airway during sleeping period promoting intermittent hypoxia-reoxygenation events. These events cause consequences such as cardiorespiratory and peripheric muscle structure alterations, which can cause reduction of the exercise tolerance. In this sense the continuous positive airway pressure (CPAP) is important to decrease the repercussions of the illness and cooperate to maintain the exercise functional capacity. To measure this capacity, one good option is the six-minute step test (6MST), that is low cost and submaximal, in addition to being adaptable and portable. However, there are doubts if it´s really capable to determinate the functional capacity of exercise of individuals with OSA treated with CPAP. Objective: Evaluate the validity and reproducibility of 6MST to determine the functional capacity of exercise in individual with OSA treated with CPAP and develop a model of a reference equation for the performance of the test in this population. Material and methods: This is an observational, prospective and cross-sectional study, in which will be evaluated 132 volunteers (66 men and 66 women), with age between 18 and 65 years, diagnosed with OSA of moderate and severe degree, treated with CPAP for a minimum of three months, recruited of the ambulatory of pneumology of Otávio de Freitas Hospital. Initially will be collected personal and anthropometric information, answered to sleep questioners, quality of sleep and physical exercise, also respiratory muscle strength and lung function. The realization of the tests to evaluate the functional capacity of exercise will be done in two days with a maximum of seven days between the tests. In each day, the volunteers will do two 6MST and two six-minute walk test (6MWT), which order will be determined by randomization. Expected Results: It is expected that the 6MST to be showed as reproducible and capable to quantify the functional capability of exercise in individuals with OSA treated with CPAP.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Other: Six-minute step test Other: Six-minute walk test

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation and Reproducibility of the Six-minute Step Test in Individuals With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure (CPAP)
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea


Intervention Details:
  • Other: Six-minute step test
    Volunteers will be instructed to go up and down one step for six minutes
  • Other: Six-minute walk test
    Volunteers will walk the longest distance possible by performing turns in a 30 meter corridor for six minutes


Primary Outcome Measures :
  1. Number of steps [ Time Frame: Two days ]
    Number of steps climbed on the six-minute step test

  2. Walked distance [ Time Frame: Two days ]
    Distance walked on six-minute walk test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals adults with obstructive sleep apnea treated with CPAP
Criteria

Inclusion Criteria:

  • Individuals with age between 18 and 65 years;
  • Obstructive Sleep Apnea on moderate and severe degree (diagnosed by polysomnography);
  • BMI bigger then 18 and less than 35 kg/m2;
  • Treatment with CPAP at least three months, with use of the equipment for a time interval superior of 4h/night during five days per week.

Exclusion Criteria:

  • Individuals with comorbidities such as uncontrolled hypertension and diabetes, orthopedic and neurologic alterations, respiratory disorders such as COPD and asthma, or any cardiovascular and respiratory which won't permit the realization of the tests.

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): NCT03334331


Locations
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Brazil
Hospital Otávio de Freitas
Recife, Pernambuco, Brazil, 50920-460
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Responsible Party: Matheus Gustavo Silva Magalhães, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03334331    
Other Study ID Numbers: 66301817.3.0000.5208
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases