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Rehabilitation for Patients With Persistent Symptoms Post COVID-19

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Concentrated rehabilitation for patients with persistent symptoms post COVID-19
Sponsored by
Western Norway University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Helse i HardangerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concentrated rehabilitation

Arm Description

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

Outcomes

Primary Outcome Measures

Cardiopulmonary exercise test (CPET)
CPET performed at treadmill
Chalder Fatigue Questionnaire (CFQ)
Assessing fatigue

Secondary Outcome Measures

International Physical Activity Questionnaire (IPAQ)
Assessing physical activity
Generalized Anxiety Disorder (GAD-7)
Evaluation of mental disorders
Patient Health Questionnaire (PHQ-9)
Assessing health status
Bergen Insomnia Scale (BIS)
Assessing sleep behavior
Client Satisfaction Questionnaire (CSQ-8)
Assessing client satisfaction with the treatment
Work and Social Adjustment Scale (WSAS)
Assessing ability to work and leisure activities.
The Brief Illness Perception Questionnaire (BIPQ)
Assessing the cognitive and emotional representations of illness.
Modified Medical Research Council Dyspnea Scale (mMRC)
Assessing dyspnea
Dyspnea-12
Assessing dyspnea
Stair Climbing Test (SCT)
Evaluation of functional exercise capacity
30 second sit to stand test (30STST)
Evaluation of functional exercise capacity
Spirometry, plethysmography and maximal voluntary ventilation
Evaluation of lung function
Bioimpedance measurement
Assessment of body composition

Full Information

First Posted
March 29, 2021
Last Updated
April 6, 2021
Sponsor
Western Norway University of Applied Sciences
Collaborators
Helse-Bergen HF
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1. Study Identification

Unique Protocol Identification Number
NCT04836351
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Norway University of Applied Sciences
Collaborators
Helse-Bergen HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study, one group pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concentrated rehabilitation
Arm Type
Experimental
Arm Description
3+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19.
Intervention Type
Other
Intervention Name(s)
Concentrated rehabilitation for patients with persistent symptoms post COVID-19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise test (CPET)
Description
CPET performed at treadmill
Time Frame
4 months
Title
Chalder Fatigue Questionnaire (CFQ)
Description
Assessing fatigue
Time Frame
4 months
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire (IPAQ)
Description
Assessing physical activity
Time Frame
4 months
Title
Generalized Anxiety Disorder (GAD-7)
Description
Evaluation of mental disorders
Time Frame
4 months
Title
Patient Health Questionnaire (PHQ-9)
Description
Assessing health status
Time Frame
4 months
Title
Bergen Insomnia Scale (BIS)
Description
Assessing sleep behavior
Time Frame
4 months
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Assessing client satisfaction with the treatment
Time Frame
3 months
Title
Work and Social Adjustment Scale (WSAS)
Description
Assessing ability to work and leisure activities.
Time Frame
4 months
Title
The Brief Illness Perception Questionnaire (BIPQ)
Description
Assessing the cognitive and emotional representations of illness.
Time Frame
4 months
Title
Modified Medical Research Council Dyspnea Scale (mMRC)
Description
Assessing dyspnea
Time Frame
4 months
Title
Dyspnea-12
Description
Assessing dyspnea
Time Frame
4 months
Title
Stair Climbing Test (SCT)
Description
Evaluation of functional exercise capacity
Time Frame
4 months
Title
30 second sit to stand test (30STST)
Description
Evaluation of functional exercise capacity
Time Frame
4 months
Title
Spirometry, plethysmography and maximal voluntary ventilation
Description
Evaluation of lung function
Time Frame
4 months
Title
Bioimpedance measurement
Description
Assessment of body composition
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bente Frisk, PhD
Phone
+4797003111
Email
bente.frisk@hvl.no
First Name & Middle Initial & Last Name or Official Title & Degree
Kiri L Njøten, MSc
Phone
+4797519412
Email
kilon@hvl.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Kvale, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
Facility Information:
Facility Name
Helse i Hardanger
City
Øystese
State/Province
Kvam Herad
ZIP/Postal Code
5610
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

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Rehabilitation for Patients With Persistent Symptoms Post COVID-19

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