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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-19

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bente Frisk, PhD; Phone Number: +4797003111; Email: bente.frisk@hvl.no
• Study Contact Backup: Name: Kiri L Njøten, MSc; Phone Number: +4797519412; Email: kilon@hvl.no

Study Locations

• Norway
  • Kvam Herad
    • Øystese, Kvam Herad, Norway, 5610
      • Recruiting
      • Helse i Hardanger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Concentrated rehabilitation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Western Norway University of Applied Sciences
• Collaborators: Helse-Bergen HF
• Investigators: Study Chair: Gerd Kvale, PhD, University of Bergen

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: long COVID; post-acute COVID syndrome; persistent symptoms post COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WesternNorwayUAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In accordance with the approvals granted for this study by The Regional Committee on Medical Research Ethics and The Norwegian Data Inspectorate, the data files are stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data can be made available to interested researchers upon reasonable request to Bente Frisk providing Norwegian privacy legislation and General Data Protection Regulation (GDPR) are respected, and that permission is granted from The Norwegian Data Inspectorate and the data protection officer Western Norway University og Applied Sciences

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No