Long COVID-19NCT05204511
Exercise and Post-COVID/ Long-COVID: Effects of Different Training Modalities on Various Parameters in People Affected by the Sequelae of COVID-19
A study testing endurance training and concurrent training 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 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, COVID-19
- What is being tested?
- endurance training and concurrent training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustria
- Study dates
- 10 Feb 2022to 31 May 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 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 Post-COVID/Long-COVID or a manifestation of reduced physical performance capacity since the infection with SARS-CoV-2
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)
- clinical diagnosis of depression
- clinical diagnosis of anxiety
- clinical diagnosis of a sleep disorder
Show all 9Show fewer
- clinical diagnosis of a cognitive deficit disorder
- 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.
About this study
Official title: Exercise and Post-COVID/Long-COVID: Effects of Different Training Modalities on Physical Performance, Heart Rate Variability, Inflammation, Health-Related Quality of Life, Cognitive Function and Post-COVID/Long-COVID19 Symptoms
The current 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 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 two different training modalities, endurance training and a combination of endurance training and resistance training, on various parameters in people affected by Post-COVID/Long-COVID.
- Conditions
- Long COVID-19, Post-COVID-19 Syndrome, COVID-19
- Being tested
- endurance training, concurrent training
- Keywords
- exercise, exercise therapy, endurance training, concurrent training, physical peformance, inflammatory markers, quality of life, concentration performance, heart rate variability
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance trainingOther
endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 30-60 minutes per session
concurrent trainingOther
combination of endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 20-40 minutes per session and resistance training of moderate intensity performing 2-3 sets of leg press, leg curls, chest press and seated horizontal rows
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID/Long-COVID endurance training group | Experimental | Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly endurance training intervention Receives: Other: endurance training |
| Post-COVID/Long-COVID concurrent training group | Experimental | Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly concurrent training intervention Receives: Other: concurrent training |
| Post-COVID/Long-COVID control group | No intervention | Participants affected by Post-COVID/Long-COVID that don't carry out an exercise intervention |
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: Baseline - 6 weeks - 12 weeks
Secondary outcomes (15)
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: Baseline - 6 weeks - 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: Baseline - 6 weeks - 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: Baseline - 6 weeks - 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).
Measured: Baseline - 6 weeks - 12 weeks
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)
hs-CRP will be assessed via blood sample.
Measured: Baseline - 6 weeks - 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)
IL-6 will be assessed via blood sample.
Measured: Baseline - 6 weeks - 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
TNF-α will be assessed via blood sample.
Measured: Baseline - 6 weeks - 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: Baseline - 6 weeks - 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: Baseline - 6 weeks - 12 weeks
Change of the number of present Post-COVID/Long-COVID specific symptoms
The number of Post-COVID/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: Baseline - 6 weeks - 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: Baseline - 6 weeks - 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: Baseline - 6 weeks - 12 weeks
Change of absolute body fat (BF measured in kg)
BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Measured: Baseline - 6 weeks - 12 weeks
Change of absolute lean body mass (LBM measured in kg)
LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Measured: Baseline - 6 weeks - 12 weeks
Change of step count per day
Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)
Measured: daily for 12 weeks starting with the first day of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start10 Feb 2022
- Primary completion31 May 2023
- Study completion31 May 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
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
- NCT05204511
- Sponsor's protocol ID
- 00726
- Status last verified
- Jul 2023
- First submitted
- 21 Jan 2022
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Post-COVID/Long-COVID: Effects of Different Training Modalities on Physical Performance, Heart Rate Variability, Inflammation, Health-Related Quality of Life, Cognitive Function and Post-COVID/Long-COVID19 Symptoms
- ClinicalTrials.gov ID
- NCT05204511
- Acronym / sponsor ID
- 00726
- Conditions
- Long COVID-19, Post-COVID-19 Syndrome, COVID-19
- Keywords
- exercise, exercise therapy, endurance training, concurrent training, physical peformance, inflammatory markers, quality of life, concentration performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 24 Jan 2022 (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 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 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 two different training modalities, endurance training and a combination of endurance training and resistance training, on various parameters in people affected by Post-COVID/Long-COVID.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-COVID/Long-COVID endurance training group | Experimental | Other: endurance trainingParticipants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly endurance training intervention |
| Post-COVID/Long-COVID concurrent training group | Experimental | Other: concurrent trainingParticipants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly concurrent training intervention |
| Post-COVID/Long-COVID control group | No intervention | –Participants affected by Post-COVID/Long-COVID that don't carry out an exercise intervention |
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 Post-COVID/Long-COVID or a manifestation of reduced physical performance capacity since the infection with SARS-CoV-2
Key exclusion criteria (9 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)
- clinical diagnosis of depression
- clinical diagnosis of anxiety
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 |
|---|---|---|
| endurance trainingendurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 30-60 minutes per session | Other | Post-COVID/Long-COVID endurance training group |
| concurrent trainingcombination of endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 20-40 minutes per session and resistance training of moderate intensity performing 2-3 sets of leg press, leg curls, chest press and seated horizontal rows | Other | Post-COVID/Long-COVID concurrent training group |
Primary outcome
Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
Time frame: Baseline - 6 weeks - 12 weeks
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.
15 secondary outcomes
Change of maximum lower body isometric muscle strength (measured in N)
Time frame: Baseline - 6 weeks - 12 weeks
Change of maximum hand grip strength (measured in kg)
Time frame: Baseline - 6 weeks - 12 weeks
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
Time frame: Baseline - 6 weeks - 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
Time frame: Baseline - 6 weeks - 12 weeks
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)
Time frame: Baseline - 6 weeks - 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)
Time frame: Baseline - 6 weeks - 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
Time frame: Baseline - 6 weeks - 12 weeks
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
Time frame: Baseline - 6 weeks - 12 weeks
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
Time frame: Baseline - 6 weeks - 12 weeks
Change of the number of present Post-COVID/Long-COVID specific symptoms
Time frame: Baseline - 6 weeks - 12 weeks
Change of fatigue assessed via the Fatigue Severity Scale (FSS)
Time frame: Baseline - 6 weeks - 12 weeks
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
Time frame: Baseline - 6 weeks - 12 weeks
Change of absolute body fat (BF measured in kg)
Time frame: Baseline - 6 weeks - 12 weeks
Change of absolute lean body mass (LBM measured in kg)
Time frame: Baseline - 6 weeks - 12 weeks
Change of step count per day
Time frame: daily for 12 weeks starting with the first day of the intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
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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 endurance training and concurrent training 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 9 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: finished, as of the sponsor's last update on 19 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Baseline - 6 weeks - 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 19 Jul 2023.