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临床试验/NCT04562857
NCT04562857已完成不适用

Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study

Cairo University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年1月1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
19
试验地点
2
主要终点
Sleep fragmentation index (in %) (the more means worse)

研究概览

简要总结

Background: There are still many gaps in research concerning the effect of different physical training modalities on sleep deprivation in the population with different types of sleep apnea. Aims: The purpose of this study was to examine the effect of moderate-intensity interval training (MITT) on patients with different types of sleep apnea.

详细描述

Methods: 15 Participants aged 45-65 years were randomized into two groups: obstructive sleep apnea group (OSA), and central sleep apnea group (CSA). The training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph together with the Pittsburg sleep quality index (PSQI) was used in sleep quality assessment. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one-minute intervals. The participants kept the device for a period of 96 hours, filled PSQI, and did 6MWT before the first and last training sessions.

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
Single (Care Provider)

入排标准

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

入选标准

  • Patients who have AF confirmed by ECG
  • Their ages range from 45 and 65 years of age
  • Medically stable patients.
  • Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
  • Patients who have OSA or CSA confirmed by polysomnography

排除标准

  • Any patient was known to have any unstable medical condition;or with any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise, was excluded from the study.

结局指标

主要结局

Sleep fragmentation index (in %) (the more means worse)

时间窗: 10 weeks

Index of the level of the sleep continuity (from the actigraph)

cutpoints

时间窗: 10 weeks

numbers displayed on the actigraph to give a picture about activity level

Total sleep time (in hours)

时间窗: 10 weeks

Total time actually slept (from the actigraph)

Sleep quality scores (0 is best, 3 is worst)

时间窗: 10 weeks

data about sleep from Pittsburgh sleep quality index questionnaire

sleep latency (in min)

时间窗: 10 weeks

time spent in bed before falling asleep (from the actigraph)

次要结局

  • six minute walking distance (in meters)(10 weeks)

研究者

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

Hady Atef Labib

Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Cairo University

研究点 (2)

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