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临床试验/NCT03673397
NCT03673397已完成不适用

The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression: a Randomized Controlled Trial

Oberwaid AG2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年9月24日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this trial is to investigate the effects of a single bout of aerobic exercise on sleep in patients with depression.

详细描述

PRIMARY OBJECTIVE:

The primary objective of this study is to evaluate whether a single bout of aerobic exercise improves sleep efficiency more than a control condition in patients with depression.

SECONDARY OBJECTIVES:

Secondary objectives are to assess the effects of a single bout of aerobic exercise on 1) sleep continuity, 2) sleep architecture, 3) pre-sleep arousal, 4) subjective sleep quality, 5) daytime sleepiness, 6) nocturnal blood pressure, 7) heart rate variability, and 8) the frequency and severity of adverse events.

DESIGN:

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 (Outcomes Assessor)

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

  • •Inpatient psychosomatic rehabilitation in the clinic OBERWAID, St.Gallen, Switzerland
  • •Age: ≥18 and ≤65 years old
  • •Primary diagnosis of depression (F32, F33) without psychotic episode according to International Statistical Classification of Diseases, 10th edition

排除标准

  • •Regular use of hypnotic agents (patients were included if no hypnotic agents were taken 2 weeks prior to study participation)
  • •Factors precluding exercise testing or training
  • •Use of beta-blockers (with the exception of Carvedilol & Nebivolol)
  • •Use of opioids
  • •History of epilepsy
  • •Restless legs syndrome defined by ≥7 points on the restless legs syndrome screening questionnaire (RLSSQ)
  • •Moderate or severe sleep apnea defined by an oxygen desaturation index (ODI) ≥15 in the first polysomnography.
  • •Morbid adiposity with BMI >40

结局指标

主要结局

Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography

时间窗: Baseline (night 1) and follow-up (night 2)

Calculated as (total sleep time / total recording time) \* 100. Higher values represent a better outcome. A one-way ANCOVA will be computed with baseline sleep efficiency (%) and minimization factors as covariates, intervention as the independent variable, and follow-up sleep efficiency (%) as the dependent variable.

次要结局

  • Change from baseline in number of awakenings at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in sleep onset latency (minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in nocturnal autonomic modulation at follow up(Baseline (night 1) and follow-up (night 2))
  • Difference in adverse events between exercise and control group(Immediately after termination of exercise intervention or control condition and after awakening from follow-up (night 2))
  • Change from baseline in stage 1 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in stage 3 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in non-rapid eye movement sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in stage shift index at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in wake after sleep onset (minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in light sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in rapid eye movement sleep-latency (minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in subjective sleep quality at follow-up assessed by self-rated questionnaire 'revised Schlaffragebogen A'(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in stage 2 sleep (% of total sleep time and minutes) at follow-up assessed by polysomnography(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in pre-sleep autonomic modulation at follow-up(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in post-sleep autonomic modulation at follow-up(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in nocturnal mean arterial pressure at follow-up assessed by pulse transit time (ECG, modified lead II; fingertip photoplethysmogram, single initial calibration measurement)(Baseline (night 1) and follow-up (night 2))
  • Change from baseline in subjective pre-sleep arousal at follow-up assessed by self-rated questionnaire 'Pre-Sleep Arousal Scale'(Baseline (night 1) and follow-up (night 2))
  • State sleepiness assessed by self-rated questionnaire 'Stanford Sleepiness Scale' (SSS)(Day 5 (i.e. day after night 2): at 08:00 am, 12 noon, 04:00 pm, and 08:00 pm)

研究者

发起方
Oberwaid AG
申办方类型
Other
责任方
Sponsor

研究点 (2)

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