Rehabilitation for Patients With Persistent Symptoms Post COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility, Usefulness and Evaluation of a Concentrated Rehabilitation for Patients With Persistent Symptoms Post COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent symptoms minimum 2 months post COVID-19 infection reduced exercise capacity level symptoms of dyspnea and/or fatigue Exclusion Criteria: diseases where exercise is contraindicated (e.g. unstable angina pectoris) drug abuse, severe mental illness where treatment in groups are contraindicated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study, one group pre-post design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentrated rehabilitation<br>3+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19. | Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-19<br>* 3+ 1-2 days concentrated rehabilitation for patients with persistent symptoms post COVID-19 with a mobile application follow-up and physical consultations at 3 months post intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise test (CPET) | CPET performed at treadmill | 4 months | 
| Chalder Fatigue Questionnaire (CFQ) | Assessing fatigue | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire (IPAQ) | Assessing physical activity | 4 months | 
| Generalized Anxiety Disorder (GAD-7) | Evaluation of mental disorders | 4 months | 
| Patient Health Questionnaire (PHQ-9) | Assessing health status | 4 months | 
| Bergen Insomnia Scale (BIS) | Assessing sleep behavior | 4 months | 
| Client Satisfaction Questionnaire (CSQ-8) | Assessing client satisfaction with the treatment | 3 months | 
| Work and Social Adjustment Scale (WSAS) | Assessing ability to work and leisure activities. | 4 months | 
| The Brief Illness Perception Questionnaire (BIPQ) | Assessing the cognitive and emotional representations of illness. | 4 months | 
| Modified Medical Research Council Dyspnea Scale (mMRC) | Assessing dyspnea | 4 months | 
| Dyspnea-12 | Assessing dyspnea | 4 months | 
| Stair Climbing Test (SCT) | Evaluation of functional exercise capacity | 4 months | 
| 30 second sit to stand test (30STST) | Evaluation of functional exercise capacity | 4 months | 
| Spirometry, plethysmography and maximal voluntary ventilation | Evaluation of lung function | 4 months | 
| Bioimpedance measurement | Assessment of body composition | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19