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Rehabilitation for Patients With Persistent Symptoms Post COVID-19

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04836351
Enrollment
20
Registered
2021-04-08
Start date
2021-03-01
Completion date
2023-12-30
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19

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.

Interventions

OTHERConcentrated rehabilitation for patients with persistent symptoms post COVID-19

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.

Sponsors

Helse-Bergen HF
CollaboratorOTHER
Western Norway University of Applied Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Feasibility study, one group pre-post design

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiopulmonary exercise test (CPET)4 monthsCPET performed at treadmill
Chalder Fatigue Questionnaire (CFQ)4 monthsAssessing fatigue

Secondary

MeasureTime frameDescription
Modified Medical Research Council Dyspnea Scale (mMRC)4 monthsAssessing dyspnea
International Physical Activity Questionnaire (IPAQ)4 monthsAssessing physical activity
Generalized Anxiety Disorder (GAD-7)4 monthsEvaluation of mental disorders
Patient Health Questionnaire (PHQ-9)4 monthsAssessing health status
Bergen Insomnia Scale (BIS)4 monthsAssessing sleep behavior
Client Satisfaction Questionnaire (CSQ-8)3 monthsAssessing client satisfaction with the treatment
Work and Social Adjustment Scale (WSAS)4 monthsAssessing ability to work and leisure activities.
The Brief Illness Perception Questionnaire (BIPQ)4 monthsAssessing the cognitive and emotional representations of illness.
Dyspnea-124 monthsAssessing dyspnea
Stair Climbing Test (SCT)4 monthsEvaluation of functional exercise capacity
30 second sit to stand test (30STST)4 monthsEvaluation of functional exercise capacity
Spirometry, plethysmography and maximal voluntary ventilation4 monthsEvaluation of lung function
Bioimpedance measurement4 monthsAssessment of body composition

Countries

Norway

Contacts

Primary ContactBente Frisk, PhD
bente.frisk@hvl.no+4797003111
Backup ContactKiri L Njøten, MSc
kilon@hvl.no+4797519412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026