Dysfunctional Breathing in Patients with Post COVID-19 Condition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Breathing pattern by Respiratory Movement Measuring Instrument (RMMI) and Health-related Quality of Life (EQ-5D-5L)
研究概览
简要总结
The goal of this observational study with a cross-sectional design is to investigate what signs, symptoms and assessment which can describe and explain dysfunctional breathing in patients with post COVID-19 condition. The main question aims to answer which measurements can identify and asses dysfunctional breathing in patients with post COVID-19 condition?
Participants for this study will be recruited from the ReCov cohort will be evaluated with diffrent measurments and questionnaires.
详细描述
The overall aim with the proposed research project is to describe and investigate the underlying mechanisms of dysfunctional breathing and the experience of living with dysfunctional breathing in patients with post-COVID-19 conditions. In addition, validate and evaluate which methods measure dysfunctional breathing regarding content validity, conceptual validity, test-retest reliability, and sensitivity to change for patients with post-COVID-19 conditions. Furthermore, to develop and evaluate an individually adapted intervention with the aim of normalizing the breathing pattern. In the next step, to evaluate the effects of an individually adapted intervention on physical and psychological function and health-related quality of life (HRQoL) in patients with post-COVID-19 conditions, as well as to describe the patients' experiences of rehabilitation.
Methods and planned studies This project is a part of a larger multi-disciplinary and multi-professional study, ReCOV, that takes a holistic perspective on the consequences of the disease. ReCOV is a three-armed project including patients, next of kin and staff (23). Patients have been followed up at the out-patient clinic for patients with PCC at Karolinska University Hospital (K).
The longitudinal observational study is about physical and psychological recovery, objectively measured physical activity and also an interview study of the patients' overall experiences of rehabilitation after COVID-19 both in the acute and long-term perspective. In total approximately 950 patients have accepted to be apart of ReCOV and to this proposed project patients will be recruited from this cohort but also from primary care. This research project will be performed in collaboration with Karolinska Institutet, Karolinska university Hospital (K), Sahlgrenska University Hospital (SH). University of Gothenburg and primary care in Region Stockholm.
Study 1: Dysfunctional breathing in patients with post COVID-19 condition?
Aim: To investigate what signs, symptoms and assessment which can describe and explain dysfunctional breathing in patients with post COVID-19 condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that state that they have persistent respiratory problems, have 2 or higher on mMRC scale or 23 and over on the Nijmegen scale will be included.
排除标准
- •Not able to perform the measurements because of cognitive or physical impairments, ongoing intervention of breathing exercises.
结局指标
主要结局
Breathing pattern by Respiratory Movement Measuring Instrument (RMMI) and Health-related Quality of Life (EQ-5D-5L)
时间窗: Assessment will be applied only once and takes about 5-10 minutes to be completed.
Will be assesed in a supine position, using the RMMI. First, during 30 seconds of tidal volume breathing. Second, during 60 seconds of performing maximal breathing manoeuvres interspaced by tidal volume breathing and then during 60 seconds after performing activity that triggers dyspnea. The RMMI records bilateral changes in the anterior posterior diameter, including both upper and lower thoracic and abdominal movements. Health-related Quality of Life is measured with EuroQualityOf Life 5 dimensions questionnaire (EQ-5D-5L), which is an instrument that evaluates the generic quality of life. EQ-5D includes a descriptive system, which comprises 5 dimensions of health: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. A descriptive index-score between 0-1, higher score indicates higher HRQoL. EQ-5D also includes a visual analog scale (VAS), which records self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL
次要结局
- Maximal Inspiratory Pressure (MIP)(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Maximal Expiratory Pressure ( MEP)(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Chest mobility(Assessment will be applied only once and takes about 5 minutes to be completed.)
- Six-minute walk test (6MWT)(Assessment will be applied only once and takes about 15 minutes to be completed.)
- Spirometry(Assessment will be applied only once and takes about 30 minutes to be completed.)
- End tidal CO2(Assessment will be applied only once and takes about 15 minutes to be completed.)
- Physical Activity level (Frändin/ Grimby)(Assessment will be applied only once and takes about 2 minutes to be completed.)
- Nijmegen questionnaire (dysfunctional breathing)(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- COPD Assessment Test (CAT)(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Dyspnea(Assessment will be applied only once and takes about 5 minutes to be completed.)
- Depression(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Anxiety(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Breathing Pattern(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Thickness of the diaphragm(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Movement of the diaphragm(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Velocity of the diaphragm(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
- Thickening fraction of the diaphragm(Assessment will be applied only once and takes about 5-10 minutes to be completed.)
研究者
Malin Nygren-Bonnier
PhD
Karolinska Institutet