Impact of Social Distancing During the COVID-19 Pandemic on Non-infected People With Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Physical activity in daily life
研究概览
简要总结
Social distancing during the COVID-19 pandemic could lead to clinical and functional deterioration of people living with chronic respiratory diseases (CRD). As they are considered risk group for COVID-19, it is not recommended that they leave their house and have interaction with people outside. Thus, most of them have not been attend Pulmonary Rehabilitation sections since the beginning of pandemic, neither exercising outdoor, experiencing drastic restrictions in their activities of daily living.
It is well known that low level of physical activity in daily life (PADL) in this population is related to poor prognosis, including higher chance of hospitalization due to exacerbation and mortality. Therefore, the aim of this study is to evaluate the short- and mid-term impact of the COVID-19 pandemic on the clinical, physical and functional conditions and the PADL level of people living with CRD (chronic obstructive pulmonary disease, asthma and interstitial lung diseases).
Participants will be assessed during the social isolation period and they will be reassessed immediately after release from social isolation. Thus, the subjects will be followed-up during 12 months to record symptoms, functional status, quality of life, exacerbations and hospitalizations.
The researchers' hypothesis is that those patients will present very low level of PADL in association to sedentarism, poor functional status, more symptoms of dyspnoea, anxiety and depression, poor sleep quality and, consequently, will present more episodes of acute exacerbation of the disease and more hospital admission during the study protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic obstructive pulmonary disease, asthma or interstitial lung disease;
- •Absence of any severe and/or unstable cardiac disease;
- •Absence of any orthopedic or neuromuscular condition that limits physical activity in daily life.
排除标准
- •Desire to leave the study at any time;
- •Infection with SARS-CoV-2 during the study protocol.
结局指标
主要结局
Physical activity in daily life
时间窗: 24 months
The totality of voluntary movement produced by skeletal muscles during everyday functioning will be assess by an activity monitor (ActiGraph) which will provide data of number of steps per day, and time spent in postures and activities of different intensities.
Patient's perception of physical activity in daily life
时间窗: 24 months
The questionnaire PROactive Physical Activity in COPD, that measures the patients' percpetion of physical activities performed in daily living, will be used to complement the evaluation of physical activity level. It is composed by 12 items that evaluate difficulty in performing activities in daily life. Each item scores from 0 to 4; the total score is provided by summing all items and higher scores indicate higher physical activity level.
次要结局
- Dyspnoea sensation in daily living(24 months)
- Hospitalization(24 months)
- Functional status(24 months)
- Acute exacerbation(24 months)
- Health-related Quality of life(24 months)
- Sleep quality(24 months)
- Anxiety and depression(24 months)
研究者
Nídia A Hernandes
Principal Investigator
Universidade Estadual de Londrina