Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06073002

Effects of a Home-Based Exercise Intervention 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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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 and Human Movement Science

Vienna, State of 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 Long-COVID

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)
  • 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

home-based concurrent exercise

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: at baseline and at 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: at baseline and at 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: at baseline and at 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: at baseline and at 12 weeks

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

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

    Time frame: at baseline an at 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.

  6. Change of the number of present Long-COVID specific symptoms

    Time frame: at baseline and at 12 weeks

    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.

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

    Time frame: at baseline and at 12 weeks

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

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

    Time frame: at baseline and at 12 weeks

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

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

    Time frame: at baseline and at 12 weeks

    IL-6 will be assessed via blood sample.

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

    Time frame: at baseline and at 12 weeks

    TNF-α will be assessed via blood sample.

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

    Time frame: at baseline and at 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.

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects with Long Covid

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Dec 11, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.