Rehabilitation for Patients With Persistent Symptoms Post COVID-19

NCT04836351 | Unknown

• 1 other identifier: WesternNorwayUAS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary exercise test (CPET)

  CPET performed at treadmill

  4 months

• Chalder Fatigue Questionnaire (CFQ)

  Assessing fatigue

  4 months

Secondary Outcomes (13)

• International Physical Activity Questionnaire (IPAQ)

  4 months

• Generalized Anxiety Disorder (GAD-7)

  4 months

• Patient Health Questionnaire (PHQ-9)

  4 months

• Bergen Insomnia Scale (BIS)

  4 months

• Client Satisfaction Questionnaire (CSQ-8)

  3 months

Study Arms (1)

Concentrated rehabilitation

EXPERIMENTAL

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

Interventions

Concentrated rehabilitation for patients with persistent symptoms post COVID-19 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.

Concentrated rehabilitation

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent symptoms minimum 2 months post COVID-19 infection
• reduced exercise capacity level
• symptoms of dyspnea and/or fatigue

You may not qualify if:

• diseases where exercise is contraindicated (e.g. unstable angina pectoris)
• drug abuse, severe mental illness where treatment in groups are contraindicated.

Sponsors & Collaborators

• Western Norway University of Applied Sciences: lead
• Helse-Bergen HF: collaborator

Study Sites (1)

Helse i Hardanger

Øystese, Kvam Herad, 5610, Norway

RECRUITING

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerd Kvale, PhD

  University of Bergen

  STUDY CHAIR

Central Study Contacts

Bente Frisk, PhD

CONTACT

+4797003111; bente.frisk@hvl.no

Kiri L Njøten, MSc

CONTACT

+4797519412; kilon@hvl.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d student

Model Details: Feasibility study, one group pre-post design

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: March 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)