跳至主要内容
临床试验/NCT03334331
NCT03334331已完成不适用

Validation and Reproducibility of the Six-minute Step Test in Individuals With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure (CPAP)

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Number of steps

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Number of steps

时间窗: Two days

Number of steps climbed on the six-minute step test

Walked distance

时间窗: Two days

Distance walked on six-minute walk test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matheus Gustavo Silva Magalhães

Principal Investigator

Universidade Federal de Pernambuco

研究点 (1)

Loading locations...

相似试验

尚未招募
3 期
Ayurveda Management Of Acute Excerbation Of Tamaka Shwasa(Bronchial Asthma) in Childre
CTRI/2023/08/056084SDM College of ayurveda and hospital Hassan
终止
2 期
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)Adult Growth Hormone Deficiency (AGHD)
NCT02719990Versartis Inc.36
已完成
4 期
An Observational study to check safety and effectiveness of CASIRIVIMAB/ IMDEVIMAB treatment of mild/moderate covid 19 patients in India
CTRI/2021/06/034375Roche Products India Pvt Ltd200
进行中(未招募)
1 期
Open-label Rollover Study to Assess Long-Term Safety in Subjects with Metastatic Cancers that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan.Metastatic Solid TumorsMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2019-004868-22-BEGilead Sciences Inc200
进行中(未招募)
1 期
Open-label Rollover Study to Assess Long-Term Safety in Subjects with Metastatic Cancers that are Benefiting from Continuation of Therapy with Sacituzumab Govitecan.Metastatic Solid TumorsMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2019-004868-22-FRImmunomedics, Inc.200