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Clinical Trials/NCT05204511
NCT05204511
Completed
Not Applicable

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

University of Vienna1 site in 1 country66 target enrollmentFebruary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Long COVID-19
Sponsor
University of Vienna
Enrollment
66
Locations
1
Primary Endpoint
Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
Status
Completed
Last Updated
2 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
February 10, 2022
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel König

Principal Investigator

University of Vienna

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Change of step count per day(daily for 12 weeks starting with the first day of the intervention period)
  • Change of maximum lower body isometric muscle strength (measured in N)(Baseline - 6 weeks - 12 weeks)
  • Change of health-related quality of life (HQoL) assessed via the SF-36 1.0(Baseline - 6 weeks - 12 weeks)
  • Change of absolute body fat (BF measured in kg)(Baseline - 6 weeks - 12 weeks)
  • Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)(Baseline - 6 weeks - 12 weeks)
  • Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale(Baseline - 6 weeks - 12 weeks)
  • Change of absolute lean body mass (LBM measured in kg)(Baseline - 6 weeks - 12 weeks)
  • Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)(Baseline - 6 weeks - 12 weeks)
  • Change of the number of present Post-COVID/Long-COVID specific symptoms(Baseline - 6 weeks - 12 weeks)
  • Change of fatigue assessed via the Fatigue Severity Scale (FSS)(Baseline - 6 weeks - 12 weeks)
  • Change of maximum hand grip strength (measured in kg)(Baseline - 6 weeks - 12 weeks)
  • Change of Standard Deviation of RR-Intervals (SDNN measured in ms)(Baseline - 6 weeks - 12 weeks)
  • Change of Root Mean Square of Successive Differences (RMSSD measured in ms)(Baseline - 6 weeks - 12 weeks)
  • Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)(Baseline - 6 weeks - 12 weeks)
  • Change of interleukin-6 (IL-6 measured in pg/ml)(Baseline - 6 weeks - 12 weeks)

Study Sites (1)

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