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CompletedNCT03334331Updated Feb 15, 2019

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

An observational study in Obstructive Sleep Apnea, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Universidade Federal de Pernambuco · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
48
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals adults with obstructive sleep apnea treated with CPAP

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

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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • OtherSix-minute step test

    Volunteers will be instructed to go up and down one step for six minutes

  • OtherSix-minute walk test

    Volunteers will walk the longest distance possible by performing turns in a 30 meter corridor for six minutes

05

What researchers measure

Primary outcomes

  1. Number of steps

    Number of steps climbed on the six-minute step test

    Time frame: Two days

  2. Walked distance

    Distance walked on six-minute walk test

    Time frame: Two days

06

Study locations

1 site
  • Hospital Otávio de Freitas
    Recife, Pernambuco 50920-460, Brazil
07

Registry details

Key details

Study ID
NCT03334331
Lead sponsor
Universidade Federal de Pernambuco
Responsible party
Matheus Gustavo Silva Magalhães (Principal Investigator, Universidade Federal de Pernambuco) — Principal investigator
First posted
Nov 7, 2017
Start date
Dec 4, 2017
Primary completion
May 21, 2018
Completion
Dec 7, 2018
Last update
Feb 15, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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