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

Sponsor

University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT05204511

Collaborator

(none)

Enrollment

Location

Arms

10.7

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID-19 Post-COVID-19 Syndrome COVID-19	Other: endurance training Other: concurrent training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Jan 24, 2022

Anticipated Primary Completion Date :

Dec 17, 2022

Anticipated Study Completion Date :

Dec 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Post-COVID/Long-COVID endurance training group Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly endurance training intervention	Other: endurance training endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 30-60 minutes per session
Experimental: Post-COVID/Long-COVID concurrent training group Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly concurrent training intervention	Other: concurrent training 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
No Intervention: Post-COVID/Long-COVID control group Participants affected by Post-COVID/Long-COVID that don't carry out an exercise intervention

Arm

Intervention/Treatment

Experimental: Post-COVID/Long-COVID endurance training group

Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly endurance training intervention

Other: endurance training

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

Experimental: Post-COVID/Long-COVID concurrent training group

Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly concurrent training intervention

Other: concurrent training

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

No Intervention: Post-COVID/Long-COVID control group

Participants affected by Post-COVID/Long-COVID that don't carry out an exercise intervention

Outcome Measures

Primary Outcome Measures

Change of peak oxygen consumption (VO2peak measured in ml/min/kg) [Baseline - 6 weeks - 12 weeks]
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.

Secondary Outcome Measures

Change of maximum lower body isometric muscle strength (measured in N) [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).
Change of maximum hand grip strength (measured in kg) [Baseline - 6 weeks - 12 weeks]
Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).
Change of Standard Deviation of RR-Intervals (SDNN measured in ms) [Baseline - 6 weeks - 12 weeks]
SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
Change of Root Mean Square of Successive Differences (RMSSD measured in ms) [Baseline - 6 weeks - 12 weeks]
RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l) [Baseline - 6 weeks - 12 weeks]
hs-CRP will be assessed via blood sample.
Change of interleukin-6 (IL-6 measured in pg/ml) [Baseline - 6 weeks - 12 weeks]
IL-6 will be assessed via blood sample.
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml) [Baseline - 6 weeks - 12 weeks]
TNF-α will be assessed via blood sample.
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0 [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.
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s) [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.
Change of the number of present Post-COVID/Long-COVID specific symptoms [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.
Change of fatigue assessed via the Fatigue Severity Scale (FSS) [Baseline - 6 weeks - 12 weeks]
The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale [Baseline - 6 weeks - 12 weeks]
The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.
Change of absolute body fat (BF measured in kg) [Baseline - 6 weeks - 12 weeks]
BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Change of absolute lean body mass (LBM measured in kg) [Baseline - 6 weeks - 12 weeks]
LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Change of step count per day [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)