Influence of Regular Physical Activity on Sleep and Anxiety in Patients With Chronic Obstructive Pulmonary Disease and Idiopathic Lung Fibrosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in sleep quality - sleepiness
研究概览
简要总结
The study looked at whether regular physical activity can influence sleep duration, sleep quality and/or anxiety in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).
The link between exercise and sleep has already been observed in the literature, but the impact of exercise on sleep is poorly understood. The question is how important is the influence of regular physical activity on sleep, anxiety and depression in patients with COPD or IPF.
详细描述
Patients will be selected in two ways:
- Intervention group: patients with COPD or idiopathic fibrosis following rehabilitation program in our center, who meet the inclusion criteria will be invited to participate in the survey and answer the questionnaires during the first week and again eight weeks after the start of the rehabilitation program.
- Control group: patients with COPD or idiopathic fibrosis who do not perform any regular physical activity will be invited to participate in the survey and answer the questionnaires.
The questionnaires are validated and the time allowed for completion is 45 minutes. The questionnaires will assess sleep quality, anxiety and symptoms of depression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD.
- •Patients with Idiopathic Pulmonary Fibrosis.
- •Patients who can read and write in French.
- •Patients who agree to participate in research and sign the informed consent form.
- •Patients who participated of our rehabilitation program or Patients who do not do any regular exercise activity.
排除标准
- •Regular use of Continuous Positive Airway Pressure devices (CPAP)
结局指标
主要结局
Changes in sleep quality - sleepiness
时间窗: 2 minutes
Sleep quality will be assessed by the questionnaire "Epworth Sleepiness Scale". A score between 0-5 indicates "lower normal daytime sleeping"; between 6-10 "higher normal daytime sleepiness; 11-12 "mil excessive daytime sleepiness"; 13-15 "moderate excessive daytime sleepiness" and 16-24 "severe excessive daytime sleepiness".
Changes in sleep quality - insomnia
时间窗: 2 minutes
Sleep quality will be assessed by the questionnaire "Insomnia Severity Index ". A scale is used to rank each item, where "0" means "no problem", "1 - mild problem", "2 - moderate" "3 - severe" and "4 very severe problem". The total score is interpreted as absence of insomnia (0-7); sub-threshold insomnia (8-14); Moderate insomnia (15-21); and severe insomnia (22-28).
Changes in sleep quality - Sleep Agenda
时间窗: 4 minutes per day
Sleep quality will be assessed by the questionnaire "Sleep Agenda". The sleep agenda is a subjective method of sleep evaluation which demand the patient to fill the agenda at two times of the day: at 9 in the morning to describe what happened at night and 9 in the evening to report what happened in the day for a minimum of three weeks. The patient need to specify the quality of his night, if it was "very good", "good", "average", "bad" and "very bad" and specify, also, if he took any medications or if something happened may have interfered with his sleep.
Changes in sleep quality - "Morningness" or "eveningness" types
时间窗: 2 minutes
Sleep quality will be assessed by the questionnaire "Morningness - Eveningness Questionnaire ". Scores between 42 and 58 indicate "neural types", scores of 59 and above indicate "morning types" and scores of 41 and below indicates "evening types".
次要结局
- Changes in back pain symptoms and disability(2 minutes)
- Changes in depression symptoms(2 minutes)
- Changes in back pain symptoms(2 minutes)
- Changes in anxiety symptoms(3 minutes)