跳至主要内容
临床试验/NCT04120428
NCT04120428Unknown不适用

Effects of a 24-week Aquatic Exercise Training Program on Obstructive Sleep Apnea Severity in Elderly Women

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
Apnea-Hypopnea Index

研究概览

简要总结

Obstructive sleep apnea syndrome (OSAS) is defined as a total cessation of upper airway flow for at least 10 seconds. OSAS is considered under diagnosed and it is assessed by a full-night sleep polysomnography. Continuous positive airway pressure (CPAP) is considered the first line treatment to OSAS, however physical exercise has emerged as an adjunct and/or alternative strategy to CPAP in OSAS patients.

详细描述

Obstructive sleep apnea syndrome (OSAS), which comprises repeated episodes of total cessation of upper airway flow during sleep, is an underdiagnosed diasease and is closely related to major physiological desadjustments that compromises the systemic health of the human organism, including triggering death events; It is not surprising, therefore, that the prevalence of OSAS in adults and elderly varies widely.

Continuous positive airway pressure (CPAP) is the instrument used as first-line treatment for OSAS because it has significant responses in attenuating the severity of the syndrome, however, the design and logistical operation of the use of this instrument compromise the adherence to OSAS treatment .

In this sense, strategies such as regular exercise practice have promising initial results for the treatment of OSAS, despite the gaps that still exist due to the scarcity of studies completed in this area. To this end, it should be noted that studies evaluating the effects of exercise on the severity of OSAS deal mostly with adults / middle-aged adults in aerobic and / or resistance exercise practices performed in a terrestrial environment with alternation only of the ergometer used. Studies on physical exercise and OSAS in the elderly present marked scarcity and only one randomized clinical trial administered to elderly men was found.

The prescription of physical exercise for the elderly requires some precautions and precautions arising from the maladjustments that senescence promotes and that compromise the functionality of organic systems. These misfits include, among other things, the attenuation of lean mass with consequent reduction in muscle strength and dynamic balance; Such damages trigger, in the elderly, fall events that, linked to the reduction of bone mineral density due to aging, not infrequently lead to the physical and functional disability of the elderly.

Physical exercise performed in the aquatic environment, therefore, emerges as a safe and effective alternative in promoting physical and functional improvements for various populations due to the physical principles of water that promote buoyancy, reduction of joint stress, subjective perception of pain and exercise fatigue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Elderly women (60 years old or aged)
  • •Apparently healthy
  • •High risk to develop OSAS
  • •Diagnosed with moderate to severe OSAS
  • •No treated to OSAS with CPAP
  • •No use of any hypnotic medicine before or during the study

排除标准

  • •Cardiovascular, pulmonary or metabolic uncontrolled diseases
  • •Inability to perform the experimental protocol or keep the usual daily life
  • •Morbid obesity by body mass index

研究组 & 干预措施

Experimental protocol

Experimental

24-week aquatic exercise training program

干预措施: Aquatic exercise training program (Other)

Control protocol

No Intervention

Maintain lifestyle routine as usual

结局指标

主要结局

Apnea-Hypopnea Index

时间窗: Full-night sleep assessment: up to 8 hours

Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam

次要结局

  • Self-related sleep quality(Face to face interview for 8 minutes)
  • Daytime excessive somnolence(Face to face interview for 3 minutes)
  • Self-related quality of life(Face to face interview for 6 minutes)
  • Depressive symptoms(Face to face interview for 2 minutes)
  • Oxygen consumption(Laboratory exam for 8-12 minutes)

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Teixeira Barbosa

Master degree

Federal University of Paraíba

研究点 (1)

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