Covid19NCT04836351
Rehabilitation for Patients With Persistent Symptoms Post COVID-19
A study testing Concentrated rehabilitation for patients with persistent symptoms post COVID-19 in people with Covid19, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Covid19
- What is being tested?
- Concentrated rehabilitation for patients with persistent symptoms post COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent symptoms minimum 2 months post COVID-19 infection
- reduced exercise capacity level
- symptoms of dyspnea and/or fatigue
Who cannot join
- diseases where exercise is contraindicated (e.g. unstable angina pectoris)
- drug abuse, severe mental illness where treatment in groups are contraindicated.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Helse i Hardanger
Øystese, Kvam Herad, 5610
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Concentrated rehabilitation for patients with persistent symptoms post COVID-19
- Keywords
- long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated rehabilitation for patients with persistent symptoms post COVID-19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Concentrated rehabilitation | Experimental | 3+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19. Receives: Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise test (CPET)
CPET performed at treadmill
Measured: 4 months
Chalder Fatigue Questionnaire (CFQ)
Assessing fatigue
Measured: 4 months
Secondary outcomes (13)
International Physical Activity Questionnaire (IPAQ)
Assessing physical activity
Measured: 4 months
Generalized Anxiety Disorder (GAD-7)
Evaluation of mental disorders
Measured: 4 months
Patient Health Questionnaire (PHQ-9)
Assessing health status
Measured: 4 months
Bergen Insomnia Scale (BIS)
Assessing sleep behavior
Measured: 4 months
Client Satisfaction Questionnaire (CSQ-8)
Assessing client satisfaction with the treatment
Measured: 3 months
Work and Social Adjustment Scale (WSAS)
Assessing ability to work and leisure activities.
Measured: 4 months
The Brief Illness Perception Questionnaire (BIPQ)
Assessing the cognitive and emotional representations of illness.
Measured: 4 months
Modified Medical Research Council Dyspnea Scale (mMRC)
Assessing dyspnea
Measured: 4 months
Dyspnea-12
Assessing dyspnea
Measured: 4 months
Stair Climbing Test (SCT)
Evaluation of functional exercise capacity
Measured: 4 months
30 second sit to stand test (30STST)
Evaluation of functional exercise capacity
Measured: 4 months
Spirometry, plethysmography and maximal voluntary ventilation
Evaluation of lung function
Measured: 4 months
Bioimpedance measurement
Assessment of body composition
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Mar 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study, one group pre-post design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Principal investigator, Kiri Lovise Njøten, Western Norway University of Applied Sciences
- Investigators
- Gerd Kvale, PhD, Study chair, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836351
- Sponsor's protocol ID
- WesternNorwayUAS
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Usefulness and Evaluation of a Concentrated Rehabilitation for Patients With Persistent Symptoms Post COVID-19
- ClinicalTrials.gov ID
- NCT04836351
- Acronym / sponsor ID
- WesternNorwayUAS
- Conditions
- Covid19
- Keywords
- long COVID, post-acute COVID syndrome, persistent symptoms post COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study, one group pre-post design
| Arm | Type | Receives |
|---|---|---|
| Concentrated rehabilitation | Experimental | Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-193+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- persistent symptoms minimum 2 months post COVID-19 infection
- reduced exercise capacity level
- symptoms of dyspnea and/or fatigue
Key exclusion criteria (2 listed)
- diseases where exercise is contraindicated (e.g. unstable angina pectoris)
- drug abuse, severe mental illness where treatment in groups are contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentrated rehabilitation for patients with persistent symptoms post COVID-193+ 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. | Other | Concentrated rehabilitation |
Primary outcome
Cardiopulmonary exercise test (CPET)
Time frame: 4 months
CPET performed at treadmill
Chalder Fatigue Questionnaire (CFQ)
Time frame: 4 months
Assessing fatigue
13 secondary outcomes
International Physical Activity Questionnaire (IPAQ)
Time frame: 4 months
Generalized Anxiety Disorder (GAD-7)
Time frame: 4 months
Patient Health Questionnaire (PHQ-9)
Time frame: 4 months
Bergen Insomnia Scale (BIS)
Time frame: 4 months
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 3 months
Work and Social Adjustment Scale (WSAS)
Time frame: 4 months
The Brief Illness Perception Questionnaire (BIPQ)
Time frame: 4 months
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 4 months
Dyspnea-12
Time frame: 4 months
Stair Climbing Test (SCT)
Time frame: 4 months
30 second sit to stand test (30STST)
Time frame: 4 months
Spirometry, plethysmography and maximal voluntary ventilation
Time frame: 4 months
Bioimpedance measurement
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Kvale, PhD study chair
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated rehabilitation for patients with persistent symptoms post COVID-19 in people with Covid19, run by Western Norway University of Applied Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bente Frisk, PhD (+4797003111, bente.frisk@hvl.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise test (CPET) (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.