Post-COVID-19 SyndromeNCT06016192
Aerobic Training for Rehabilitation of Patients With Post Covid-19 Syndrome
A study testing Aerobic Exercise Training in people with Post-COVID-19 Syndrome and Long-COVID-19 Syndrome, run by University of Witten/Herdecke at 1 site in Germany.
Trial summary
Post-COVID-19 syndrome (PCS) occurs as a sequelae after acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is defined as symptom persistence over a period of 12 weeks from infection and/or the appearance of new symptoms in this period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- What is being tested?
- Aerobic Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of (at least one) Covid-19 infection
- ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment
- referral to inpatient rehabilitation
- signed informed consent
Who cannot join
- unstable condition
- incapable of understanding study information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Rehabilitation of Patients With Long-term Post-Covid-19 Syndrome - a Comparison of Aerobic Interval and Continuous Training
Post-COVID-19 syndrome (PCS) occurs as a sequelae after acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is defined as symptom persistence over a period of 12 weeks from infection and/or the appearance of new symptoms in this period. While the majority of affected patients experience a gradual healing process without targeted treatment, the need for effective medical rehabilitation is high at least for patients with persistent PCS.
Given that physical exercise has been shown to be beneficial in multiple pathologies such as cardiovascular diseases, neuropathic disorders, and pulmonary diseases it has been suggested that physical exercise including aerobic training could exert beneficial effects also in PCS. This study aims to analyse the use of moderate-intensity aerobic exercise training for medical rehabilitation of PCS patients.
Read the detailed description
Post-COVID-19 syndrome (PCS) is a condition that occurs following an acute infection with the SARS-CoV-2 virus (COVID-19). PCS is characterized by symptom persistence for at least 12 weeks after the infection or the emergence of new symptoms during this period. Current guidelines propose several criteria for diagnosing PCS, including persistent symptoms from the acute COVID-19 phase, new symptoms leading to health limitations, symptoms assumed to be related to COVID-19 after the acute phase, and worsening of pre-existing underlying conditions. PCS is a complex and multisystemic disorder, with symptoms ranging from chronic fatigue, decreased physical performance, muscular weakness, and pain to cognitive impairment (often referred to as brain fog) and mental and psychological distress resembling a post-traumatic stress reaction. The exact causes of PCS are not fully understood but may involve processes such as endothelial dysfunction, cytokine storm, and increased oxidative stress affecting various organs and structures in the body. The incidence of PCS varies depending on the population studied and the severity of symptoms considered, with estimates ranging from 7.5% to 41% among non-hospitalized patients with acute infection.
Medical rehabilitation is essential for patients with persistent PCS, but there are limited studies on its efficacy, especially in the context of aerobic endurance training. Physical exercise, including aerobic training, has shown positive effects in various diseases, and it is suggested that it may be beneficial for PCS as well. However, there is limited evidence regarding the effectiveness of aerobic endurance training in reducing the burden of decreased physical performance in PCS. Moreover, there is a lack of guidelines for PCS patients related to exercise-based rehabilitation. Aerobic endurance training has been proven to have positive effects on multiple physiological functions and is recommended for chronic heart and pulmonary diseases. Studies have also suggested that aerobic interval training may be advantageous for PCS patients, as it reduces ventilatory demand and may alleviate dyspnea and breathing effort. This study aims to investigate the efficacy of moderate-intensity aerobic endurance training performed as either continuous training and interval training for the medical rehabilitation of PCS patients.
The study will include PCS patients referred for inpatient medical rehabilitation in Germany with a history of (at least one) Covid-19 infection and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment. Performance deficits will be documented according to the recent consensus statement, with the cluster of lead symptoms including fatigue/exercise intolerance, shortness of breath, and cognitive dysfunction impairing activity of daily living and everyday functioning. A detailed clinical workup will be performed, and the history of comorbidities and current medication will be documented. After admission, patients will be randomized to a continuous training (CT) or interval training (IT) group. Patients will receive individual medical rehabilitation including a combination of strength, respiratory and cognitive training, as well as physio-, psycho- and nutrition therapy, unaltered for both groups. Data on medical rehabilitation including prescriptions of therapeutic actions and participation will be recorded for all patients. Symptom-limited spiroergometry at admission and after 4-6 weeks of inpatient rehabilitation (before discharge) will be performed to analyze improvements in exercise capacity. Validated questionnaires will be used to document patients' disease perception.
- Conditions
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- Being tested
- Aerobic Exercise Training
- Keywords
- COVID-19, Fatigue, Rehabilitation, Exercise Training, Infectious Disease
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19, Fatigue, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
Physical activity performed as controlled aerobic exercise training on ergometer
| Study group | Role | What they receive |
|---|---|---|
| Continuous aerobic training | Active comparator | Moderate continous endurance training, ergometer Receives: Behavioral: Aerobic Exercise Training |
| Interval aerobic training | Experimental | Moderate intensity interval training, ergometer Receives: Behavioral: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiorespiratory Fitness (CRF)
CRF will be measured as peak oxygen uptake (VO2peak) determined by spiroergometry
Measured: Baseline and week 4 (i. e. before discharge)
Secondary outcomes (6)
Change in Submaximal Cardiorespiratory Fitness (CRF)
Submaximal CRF will be measured as submaximal oxygen uptake (VO2 at ventilatory threshold 1 [VT1]) determined by spiroergometry
Measured: Baseline and week 4 (i. e. before discharge)
Change in Fatigue
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Measured: Baseline and week 4 (i. e. before discharge)
Work requirements and workload
Work requirements and workload will be assessed using the "Workability Index (WAI)".
Measured: Baseline
Change Health-related quality of life
Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
Measured: Baseline and week 4 (i. e. before discharge)
Wellbeing
Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Measured: Baseline and week 4 (i. e. before discharge)
Change in Depression and Anxiety
Depression and Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and week 4 (i. e. before discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Aug 2021
- Primary completion30 Nov 2022
- 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 Post-COVID-19 SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Rehabilitationsforschung Norderney
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016192
- Sponsor's protocol ID
- PCS_Training_01
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Rehabilitation of Patients With Long-term Post-Covid-19 Syndrome - a Comparison of Aerobic Interval and Continuous Training
- ClinicalTrials.gov ID
- NCT06016192
- Acronym / sponsor ID
- PCS_Training_01
- Conditions
- Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
- Keywords
- COVID-19, Fatigue, Rehabilitation, Exercise Training, Infectious Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Institut für Rehabilitationsforschung Norderney
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Aug 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.
Post-COVID-19 syndrome (PCS) occurs as a sequelae after acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is defined as symptom persistence over a period of 12 weeks from infection and/or the appearance of new symptoms in this period. While the majority of affected patients experience a gradual healing process without targeted treatment, the need for effective medical rehabilitation is high at least for patients with persistent PCS.
Given that physical exercise has been shown to be beneficial in multiple pathologies such as cardiovascular diseases, neuropathic disorders, and pulmonary diseases it has been suggested that physical exercise including aerobic training could exert beneficial effects also in PCS. This study aims to analyse the use of moderate-intensity aerobic exercise training for medical rehabilitation of PCS patients.
Detailed description
Post-COVID-19 syndrome (PCS) is a condition that occurs following an acute infection with the SARS-CoV-2 virus (COVID-19). PCS is characterized by symptom persistence for at least 12 weeks after the infection or the emergence of new symptoms during this period. Current guidelines propose several criteria for diagnosing PCS, including persistent symptoms from the acute COVID-19 phase, new symptoms leading to health limitations, symptoms assumed to be related to COVID-19 after the acute phase, and worsening of pre-existing underlying conditions. PCS is a complex and multisystemic disorder, with symptoms ranging from chronic fatigue, decreased physical performance, muscular weakness, and pain to cognitive impairment (often referred to as brain fog) and mental and psychological distress resembling a post-traumatic stress reaction. The exact causes of PCS are not fully understood but may involve processes such as endothelial dysfunction, cytokine storm, and increased oxidative stress affecting various organs and structures in the body. The incidence of PCS varies depending on the population studied and the severity of symptoms considered, with estimates ranging from 7.5% to 41% among non-hospitalized patients with acute infection.
Medical rehabilitation is essential for patients with persistent PCS, but there are limited studies on its efficacy, especially in the context of aerobic endurance training. Physical exercise, including aerobic training, has shown positive effects in various diseases, and it is suggested that it may be beneficial for PCS as well. However, there is limited evidence regarding the effectiveness of aerobic endurance training in reducing the burden of decreased physical performance in PCS. Moreover, there is a lack of guidelines for PCS patients related to exercise-based rehabilitation. Aerobic endurance training has been proven to have positive effects on multiple physiological functions and is recommended for chronic heart and pulmonary diseases. Studies have also suggested that aerobic interval training may be advantageous for PCS patients, as it reduces ventilatory demand and may alleviate dyspnea and breathing effort. This study aims to investigate the efficacy of moderate-intensity aerobic endurance training performed as either continuous training and interval training for the medical rehabilitation of PCS patients.
The study will include PCS patients referred for inpatient medical rehabilitation in Germany with a history of (at least one) Covid-19 infection and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment. Performance deficits will be documented according to the recent consensus statement, with the cluster of lead symptoms including fatigue/exercise intolerance, shortness of breath, and cognitive dysfunction impairing activity of daily living and everyday functioning. A detailed clinical workup will be performed, and the history of comorbidities and current medication will be documented. After admission, patients will be randomized to a continuous training (CT) or interval training (IT) group. Patients will receive individual medical rehabilitation including a combination of strength, respiratory and cognitive training, as well as physio-, psycho- and nutrition therapy, unaltered for both groups. Data on medical rehabilitation including prescriptions of therapeutic actions and participation will be recorded for all patients. Symptom-limited spiroergometry at admission and after 4-6 weeks of inpatient rehabilitation (before discharge) will be performed to analyze improvements in exercise capacity. Validated questionnaires will be used to document patients' disease perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized
| Arm | Type | Receives |
|---|---|---|
| Continuous aerobic training | Active comparator | Behavioral: Aerobic Exercise TrainingModerate continous endurance training, ergometer |
| Interval aerobic training | Experimental | Behavioral: Aerobic Exercise TrainingModerate intensity interval training, ergometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a history of (at least one) Covid-19 infection
- ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment
- referral to inpatient rehabilitation
- signed informed consent
Key exclusion criteria (2 listed)
- unstable condition
- incapable of understanding study information
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 |
|---|---|---|
| Aerobic Exercise TrainingPhysical activity performed as controlled aerobic exercise training on ergometer | Behavioural | Continuous aerobic training, Interval aerobic training |
Primary outcome
Change in Cardiorespiratory Fitness (CRF)
Time frame: Baseline and week 4 (i. e. before discharge)
CRF will be measured as peak oxygen uptake (VO2peak) determined by spiroergometry
6 secondary outcomes
Change in Submaximal Cardiorespiratory Fitness (CRF)
Time frame: Baseline and week 4 (i. e. before discharge)
Change in Fatigue
Time frame: Baseline and week 4 (i. e. before discharge)
Work requirements and workload
Time frame: Baseline
Change Health-related quality of life
Time frame: Baseline and week 4 (i. e. before discharge)
Wellbeing
Time frame: Baseline and week 4 (i. e. before discharge)
Change in Depression and Anxiety
Time frame: Baseline and week 4 (i. e. before discharge)
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 1 Sep 2023.
Related trials for Post-COVID-19 Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
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
Systemic Inflammation, Neuroinflammation
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 Aerobic Exercise Training in people with Post-COVID-19 Syndrome and Long-COVID-19 Syndrome, run by University of Witten/Herdecke at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 1 Sep 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 Germany. 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 in Cardiorespiratory Fitness (CRF) (time frame: Baseline and week 4 (i. e. before discharge)). 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 1 Sep 2023.