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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Aerobic Exercise Training
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.

Germany1 site
  • Clinic Königsfeld

    Ennepetal, North Rhine-Westphalia, 58256

Other trials in Germany

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.

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 groups in NCT06016192
Study groupRoleWhat they receive
Continuous aerobic trainingActive comparatorModerate continous endurance training, ergometer
Receives: Behavioral: Aerobic Exercise Training
Interval aerobic trainingExperimentalModerate 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.

  1. 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)
  1. 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)

  2. Change in Fatigue

    Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".

    Measured: Baseline and week 4 (i. e. before discharge)

  3. Work requirements and workload

    Work requirements and workload will be assessed using the "Workability Index (WAI)".

    Measured: Baseline

  4. 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)

  5. Wellbeing

    Wellbeing will be assessed using the "WHO-5 Well-Being Index".

    Measured: Baseline and week 4 (i. e. before discharge)

  6. 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.

  1. First posted29 Aug 2023
  2. Study start1 Aug 2021
  3. Primary completion30 Nov 2022
  4. Study completion31 May 2023

Resources

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)
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

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.

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