Feasibility, Usefulness and Evaluation of a Concentrated Rehabilitation for Patients With Persistent Symptoms Post COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cardiopulmonary exercise test (CPET)
研究概览
简要总结
A large proportion of persons who have had COVID-19 have reported persisted symptoms as fatigue and dyspnea months post infection which affect activities of daily living.
The aim of the study is to examine the feasibility and safety of a concentrated rehabilitation program with a mobile application follow-up for persons with persistent symptoms post COVID-19 infection. We will examine recruitment availability, adherence to the program, goal achievement, and resources requirements.
Methods: A feasibility study with one group pre-post test design with 10-20 persons between 18-67 years, with persistent symptoms post COVID-19 will be included. The intervention is 3+ 1-2 days concentrated rehabilitation with a mobile application follow-up for 3 months.
Following assessments wil be used: Cardiopulmonary exercise testing, lung function, functional performance tests, questionnaires regarding dyspnea, fatigue, anxiety, depression, work-status, health status, sleep behavior, physical activity level.
Demographic data before and after the intervention will be presented. Focus group interview will be done with the participants. The interview will be analysed using systematic text condensation.
详细描述
In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak to be a pandemic, and a year later more than 120 000 000 people are confirmed with the disease. The disease has caused more than 2 700 000 deaths globally. Norway has a low mortality rate compared to rest of the world. However, a large proportion (10-33%) of the patients worldwide have reported persistent symptoms, such as dyspnea, reduced exercise capacity, loss of taste/smell and fatigue months after the infection. Persistent symptoms are also found in younger populations and in persons with an initially mild disease.
The intervention will take place at "Helse i Hardanger" (HiH)(Health center in Hardanger, Norway). The participants will stay for a 3 -day rehabilitation intervention, if needed, another 1 or 2-day stay will be offered about a month later. The concentrated treatment will be given by an interdisciplinary team, including doctors, physiotherapists, nutritionists, pharmacists, psychologists/psychiatrists, and nurses. The intervention is an individualized group treatment based on behavioural change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent symptoms minimum 2 months post COVID-19 infection
- •reduced exercise capacity level
- •symptoms of dyspnea and/or fatigue
排除标准
- •diseases where exercise is contraindicated (e.g. unstable angina pectoris)
- •drug abuse, severe mental illness where treatment in groups are contraindicated.
结局指标
主要结局
Cardiopulmonary exercise test (CPET)
时间窗: 4 months
CPET performed at treadmill
Chalder Fatigue Questionnaire (CFQ)
时间窗: 4 months
Assessing fatigue
次要结局
- Client Satisfaction Questionnaire (CSQ-8)(3 months)
- Work and Social Adjustment Scale (WSAS)(4 months)
- Patient Health Questionnaire (PHQ-9)(4 months)
- Bergen Insomnia Scale (BIS)(4 months)
- The Brief Illness Perception Questionnaire (BIPQ)(4 months)
- Modified Medical Research Council Dyspnea Scale (mMRC)(4 months)
- Dyspnea-12(4 months)
- Stair Climbing Test (SCT)(4 months)
- 30 second sit to stand test (30STST)(4 months)
- Spirometry, plethysmography and maximal voluntary ventilation(4 months)
- Bioimpedance measurement(4 months)
- International Physical Activity Questionnaire (IPAQ)(4 months)
- Generalized Anxiety Disorder (GAD-7)(4 months)
研究者
Kiri Lovise Njøten
Ph.d student
Western Norway University of Applied Sciences