Clinical trial NCT04836351: Rehabilitation for Patients With Persistent Symptoms Post COVID-19
Official title: Feasibility, Usefulness and Evaluation of a Concentrated Rehabilitation for Patients With Persistent Symptoms Post COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: long COVID
post-acute COVID syndrome
persistent symptoms post COVID-19
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Helse-Bergen HF
First posted: 2021-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study, one group pre-post design
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiopulmonary exercise test (CPET)
timeFrame: 4 months
measure: Chalder Fatigue Questionnaire (CFQ)
timeFrame: 4 months
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 4 months
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 4 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 4 months
measure: Bergen Insomnia Scale (BIS)
timeFrame: 4 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3 months
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 4 months
measure: The Brief Illness Perception Questionnaire (BIPQ)
timeFrame: 4 months
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: 4 months
measure: Dyspnea-12
timeFrame: 4 months
measure: Stair Climbing Test (SCT)
timeFrame: 4 months
measure: 30 second sit to stand test (30STST)
timeFrame: 4 months
measure: Spirometry, plethysmography and maximal voluntary ventilation
timeFrame: 4 months
measure: Bioimpedance measurement
timeFrame: 4 months
Other outcomes:
Locations:
city: Øystese
country: Norway
facility: Helse i Hardanger
state: Kvam Herad
Study officials:
affiliation: University of Bergen
name: Gerd Kvale, PhD
role: STUDY_CHAIR
References: