Long COVID-19NCT06073002
Effects of a Home-Based Exercise Intervention in Subjects with Long COVID
A study testing home-based concurrent exercise in people with Long COVID-19 and Post-COVID-19 Syndrome, run by University of Vienna at 1 site in Austria.
Trial summary
The current Coronavirus Disease 2019 (COVID-19) pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long COVID-19, Post-COVID-19 Syndrome
- What is being tested?
- home-based concurrent exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 4 Sep 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laboratory-confirmed infection with SARS-CoV-2 via PCR a minimum of 12 weeks ago
- presence of at least one or more of persistent symptoms that can be attributed to Long-COVID
Who cannot join
- previous or current hospitalization due to the COVID-19 disease
- regular engagement in endurance or strength training (more than once per week) in the six months prior to enrollment
- contraindications for physical endurance and resistance exercise according to the guidelines of the American College of Sports Medicine (ACSM)
- a grade of 3 or higher on the Post-COVID-19 Functional Status Scale (PCFS)
- presence of post exertional malaise (PEM)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sport and Human Movement Science
Vienna, State of Vienna, 1150
About this study
Official title: Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects with Long Covid
The current Coronavirus Disease 2019 (COVID-19) pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. The presence of symptoms longer than 3 months after the infection with the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is referred to as Post-COVID-19 Syndrome or Long COVID-19. It is estimated that 10-20 percent of all infected people are affected. The most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration.
Considering the novelty of the pathology, evidence on the successful treatment of Post-COVID/Long-COVID is scarce. Physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of Post-COVID/Long-COVID. For example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. However, there has been controversy whether so-called Graded Exercise Therapy (GET) is a safe treatment strategy for patients with Chronic Fatigue Syndrome (CFS). This population may experience Post Exertional Malaise (PEM), a worsening of symptoms after physical, cognitive or emotional exertion. Since COVID-19 might be an infectious trigger for CFS, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention.
Read more
It can be hypothesized that patients suffering from Post-COVID/Long-COVID can benefit from exercise in various ways, guaranteed that there is sufficient screening for PEM before and during the intervention and training volume and intensity are increased slowly and progressively.
The current study investigates the effects of a home-based concurrent training program on various parameters in people affected by Long COVID.
- Conditions
- Long COVID-19, Post-COVID-19 Syndrome
- Being tested
- home-based concurrent exercise
- Keywords
- exercise, exercise therapy, concurrent training, exercise rehabilitation, Long COVID-19, Post-COVID-19 Syndrome, home-based training
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based concurrent exerciseOther
3 weekly sessions of home-based concurrent exercise on non-consecutive days. Resistance exercise is comprised of lunges, hip thrusts, pushups, resistance band rows, core and performed for 3 sets with 15-20 repetitions at an RPE of 14-18 (6-20 BORG scale). Endurance exercise can be done by the mode of choice and is monitored by heartrate zones. Sessions are of low to moderate intensity (below VT2) and the duration will be slowly increased for 20-40min.
| Study group | Role | What they receive |
|---|---|---|
| Home-based concurrent training | Experimental | Combination of resistance training (5 exercises with bodyweight and/or resistance bands; 3 sets per exercise, 15-20 repetitions) and endurance training (mode of choice, light to moderate intensities which are monitored via heartrate zones, 20-40min per sessions); 3 weekly sessions on non-consecutive days Receives: Other: home-based concurrent exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.
Measured: at baseline and at 12 weeks
Secondary outcomes (11)
Change of maximum lower body isometric muscle strength (measured in N)
Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).
Measured: at baseline and at 12 weeks
Change of maximum hand grip strength (measured in kg)
Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).
Measured: at baseline and at 12 weeks
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
Measured: at baseline and at 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
RMSSD will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
Measured: at baseline and at 12 weeks
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
The SF-36 1.0 is self-administered questionnaire and will be scored according to RAND (numeric value of 0-100). A high score represents a more favorable health status.
Measured: at baseline an at 12 weeks
Change of the number of present Long-COVID specific symptoms
The number of Long-COVID specific symptoms will be assessed using a list of symptoms provided by the National Institute for Health Care and Excellence (NICE). Each item will be referenced to as existent (yes) or non-existent (no) during the last 7 days.
Measured: at baseline and at 12 weeks
Change of fatigue assessed via the Fatigue Severity Scale (FSS)
The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale
Measured: at baseline and at 12 weeks
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.
Measured: at baseline and at 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)
IL-6 will be assessed via blood sample.
Measured: at baseline and at 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
TNF-α will be assessed via blood sample.
Measured: at baseline and at 12 weeks
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
CR will be assessed via Cognitrone (Schuhfried GmbH), which is a carefully administered computer test. Participants will be given the task of comparing a series of geometric figures.
Measured: at baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Sep 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel König, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073002
- Sponsor's protocol ID
- 01017
- Status last verified
- Dec 2024
- First submitted
- 6 Oct 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects with Long Covid
- ClinicalTrials.gov ID
- NCT06073002
- Acronym / sponsor ID
- 01017
- Conditions
- Long COVID-19, Post-COVID-19 Syndrome
- Keywords
- exercise, exercise therapy, concurrent training, exercise rehabilitation, Long COVID-19, Post-COVID-19 Syndrome, home-based training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 Oct 2023 (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.
The current Coronavirus Disease 2019 (COVID-19) pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. The presence of symptoms longer than 3 months after the infection with the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is referred to as Post-COVID-19 Syndrome or Long COVID-19. It is estimated that 10-20 percent of all infected people are affected. The most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration.
Considering the novelty of the pathology, evidence on the successful treatment of Post-COVID/Long-COVID is scarce. Physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of Post-COVID/Long-COVID. For example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. However, there has been controversy whether so-called Graded Exercise Therapy (GET) is a safe treatment strategy for patients with Chronic Fatigue Syndrome (CFS). This population may experience Post Exertional Malaise (PEM), a worsening of symptoms after physical, cognitive or emotional exertion. Since COVID-19 might be an infectious trigger for CFS, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention.
It can be hypothesized that patients suffering from Post-COVID/Long-COVID can benefit from exercise in various ways, guaranteed that there is sufficient screening for PEM before and during the intervention and training volume and intensity are increased slowly and progressively.
The current study investigates the effects of a home-based concurrent training program on various parameters in people affected by Long COVID.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based concurrent training | Experimental | Other: home-based concurrent exerciseCombination of resistance training (5 exercises with bodyweight and/or resistance bands; 3 sets per exercise, 15-20 repetitions) and endurance training (mode of choice, light to moderate intensities which are monitored via heartrate zones, 20-40min per sessions); 3 weekly sessions on non-consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- laboratory-confirmed infection with SARS-CoV-2 via PCR a minimum of 12 weeks ago
- presence of at least one or more of persistent symptoms that can be attributed to Long-COVID
Key exclusion criteria (5 listed)
- previous or current hospitalization due to the COVID-19 disease
- regular engagement in endurance or strength training (more than once per week) in the six months prior to enrollment
- contraindications for physical endurance and resistance exercise according to the guidelines of the American College of Sports Medicine (ACSM)
- a grade of 3 or higher on the Post-COVID-19 Functional Status Scale (PCFS)
- presence of post exertional malaise (PEM)
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 |
|---|---|---|
| home-based concurrent exercise3 weekly sessions of home-based concurrent exercise on non-consecutive days. Resistance exercise is comprised of lunges, hip thrusts, pushups, resistance band rows, core and performed for 3 sets with 15-20 repetitions at an RPE of 14-18 (6-20 BORG scale). Endurance exercise can be done by the mode of choice and is monitored by heartrate zones. Sessions are of low to moderate intensity (below VT2) and the duration will be slowly increased for 20-40min. | Other | Home-based concurrent training |
Primary outcome
Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
Time frame: at baseline and at 12 weeks
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.
11 secondary outcomes
Change of maximum lower body isometric muscle strength (measured in N)
Time frame: at baseline and at 12 weeks
Change of maximum hand grip strength (measured in kg)
Time frame: at baseline and at 12 weeks
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
Time frame: at baseline and at 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
Time frame: at baseline and at 12 weeks
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
Time frame: at baseline an at 12 weeks
Change of the number of present Long-COVID specific symptoms
Time frame: at baseline and at 12 weeks
Change of fatigue assessed via the Fatigue Severity Scale (FSS)
Time frame: at baseline and at 12 weeks
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
Time frame: at baseline and at 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)
Time frame: at baseline and at 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
Time frame: at baseline and at 12 weeks
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
Time frame: at baseline and at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Long COVID-19
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based concurrent exercise in people with Long COVID-19 and Post-COVID-19 Syndrome, run by University of Vienna at 1 site in Austria.
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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of peak oxygen consumption (VO2peak measured in ml/min/kg) (time frame: at baseline and at 12 weeks). 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 11 Dec 2024.