Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects with Long Covid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Vienna
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Home-based concurrent training
Combination of resistance training (5 exercises with bodyweight and/or resistance bands; 3 sets per exercise, 15-20 repetitions) and endurance training (mode of choice, light to moderate intensities which are monitored via heartrate zones, 20-40min per sessions); 3 weekly sessions on non-consecutive days
Intervention: home-based concurrent exercise (Other)
Outcomes
Primary Outcomes
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
- Change of Standard Deviation of RR-Intervals (SDNN measured in ms)(at baseline and at 12 weeks)
- Change of maximum lower body isometric muscle strength (measured in N)(at baseline and at 12 weeks)
- Change of the number of present Long-COVID specific symptoms(at baseline and at 12 weeks)
- Change of fatigue assessed via the Fatigue Severity Scale (FSS)(at baseline and at 12 weeks)
- Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale(at baseline and at 12 weeks)
- Change of Root Mean Square of Successive Differences (RMSSD measured in ms)(at baseline and at 12 weeks)
- Change of health-related quality of life (HQoL) assessed via the SF-36 1.0(at baseline an at 12 weeks)
- Change of maximum hand grip strength (measured in kg)(at baseline and at 12 weeks)
- Change of interleukin-6 (IL-6 measured in pg/ml)(at baseline and at 12 weeks)
- Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)(at baseline and at 12 weeks)
- Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)(at baseline and at 12 weeks)
Investigators
Daniel König
Principal Investigator
University of Vienna