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NCT Number: NCT05204511

Exercise and Post-COVID/ Long-COVID: Effects of Different Training Modalities on Various Parameters in People Affected by the Sequelae of COVID-19

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.

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Key information

Conditions

Long COVID-19 Behavior COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Motor Activity Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sport Science, University of Vienna

Vienna, 1150, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Endurance training

Other

endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 30-60 minutes per session

Concurrent training

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change of maximum lower body isometric muscle strength (measured in N)

    Time frame: Baseline - 6 weeks - 12 weeks

    Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).

  2. Change of maximum hand grip strength (measured in kg)

    Time frame: Baseline - 6 weeks - 12 weeks

    Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).

  3. Change of Standard Deviation of RR-Intervals (SDNN measured in ms)

    Time frame: Baseline - 6 weeks - 12 weeks

    SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).

  4. Change of Root Mean Square of Successive Differences (RMSSD measured in ms)

    Time frame: Baseline - 6 weeks - 12 weeks

    RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).

  5. Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)

    Time frame: Baseline - 6 weeks - 12 weeks

    hs-CRP will be assessed via blood sample.

  6. Change of interleukin-6 (IL-6 measured in pg/ml)

    Time frame: Baseline - 6 weeks - 12 weeks

    IL-6 will be assessed via blood sample.

  7. Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)

    Time frame: Baseline - 6 weeks - 12 weeks

    TNF-α will be assessed via blood sample.

  8. Change of health-related quality of life (HQoL) assessed via the SF-36 1.0

    Time frame: Baseline - 6 weeks - 12 weeks

    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.

  9. Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)

    Time frame: Baseline - 6 weeks - 12 weeks

    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.

  10. Change of the number of present Post-COVID/Long-COVID specific symptoms

    Time frame: Baseline - 6 weeks - 12 weeks

    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.

  11. Change of fatigue assessed via the Fatigue Severity Scale (FSS)

    Time frame: Baseline - 6 weeks - 12 weeks

    The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale

  12. Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale

    Time frame: Baseline - 6 weeks - 12 weeks

    The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.

  13. Change of absolute body fat (BF measured in kg)

    Time frame: Baseline - 6 weeks - 12 weeks

    BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).

  14. Change of absolute lean body mass (LBM measured in kg)

    Time frame: Baseline - 6 weeks - 12 weeks

    LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).

  15. Change of step count per day

    Time frame: daily for 12 weeks starting with the first day of the intervention period

    Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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