Clinical trial NCT05204511: Exercise and Post-COVID/ Long-COVID: Effects of Different Training Modalities on Various Parameters in People Affected by the Sequelae of COVID-19
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID-19
Post-COVID-19 Syndrome
COVID-19
Keywords: exercise
exercise therapy
endurance training
concurrent training
physical peformance
inflammatory markers
quality of life
concentration performance
heart rate variability
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
timeFrame: Baseline - 6 weeks - 12 weeks
Secondary outcomes:
measure: Change of maximum lower body isometric muscle strength (measured in N)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of maximum hand grip strength (measured in kg)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of interleukin-6 (IL-6 measured in pg/ml)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of the number of present Post-COVID/Long-COVID specific symptoms
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of fatigue assessed via the Fatigue Severity Scale (FSS)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of absolute body fat (BF measured in kg)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of absolute lean body mass (LBM measured in kg)
timeFrame: Baseline - 6 weeks - 12 weeks
measure: Change of step count per day
timeFrame: daily for 12 weeks starting with the first day of the intervention period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Sport Science, University of Vienna
Study officials:
References: