Rehabilitation for Patients With Persistent Symptoms Post COVID-19

NCT ID: NCT04836351

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-30

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.

Conditions

Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Concentrated rehabilitation

3+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19.

Group Type: EXPERIMENTAL

Concentrated rehabilitation for patients with persistent symptoms post COVID-19

Intervention Type: OTHER

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.

Interventions

Concentrated 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse-Bergen HF

OTHER

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Kiri Lovise Njøten

Ph.d student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerd Kvale, PhD

Role: STUDY_CHAIR

University of Bergen

Locations

Helse i Hardanger

Øystese, Kvam Herad, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Bente Frisk, PhD

Role: CONTACT

bente.frisk@hvl.no

+4797003111

Kiri L Njøten, MSc

Role: CONTACT

kilon@hvl.no

+4797519412

Other Identifiers

WesternNorwayUAS

Identifier Type: -

Identifier Source: org_study_id