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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Post-COVID-19 Syndrome; Long COVID-19
• Intervention / Treatment: Other: endurance training; Other: concurrent training

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna Sick, MSc; Phone Number: +43-1-4277-59118; Email: johanna.sick@univie.ac.at
• Study Contact Backup: Name: Anna M Moitzi, BSc Bakk. MSc; Phone Number: +43-1-4277-54996; Email: anna.moitzi@univie.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1150
    • Department of Sport Science, University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of maximum lower body isometric muscle strength (measured in N)	Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).	Baseline - 6 weeks - 12 weeks
Change of maximum hand grip strength (measured in kg)	Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).	Baseline - 6 weeks - 12 weeks
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)	SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).	Baseline - 6 weeks - 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)	RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).	Baseline - 6 weeks - 12 weeks
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)	hs-CRP will be assessed via blood sample.	Baseline - 6 weeks - 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)	IL-6 will be assessed via blood sample.	Baseline - 6 weeks - 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)	TNF-α will be assessed via blood sample.	Baseline - 6 weeks - 12 weeks
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0	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.	Baseline - 6 weeks - 12 weeks
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)	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.	Baseline - 6 weeks - 12 weeks
Change of the number of present Post-COVID/Long-COVID specific symptoms	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.	Baseline - 6 weeks - 12 weeks
Change of fatigue assessed via the Fatigue Severity Scale (FSS)	The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale	Baseline - 6 weeks - 12 weeks
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale	The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.	Baseline - 6 weeks - 12 weeks
Change of absolute body fat (BF measured in kg)	BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).	Baseline - 6 weeks - 12 weeks
Change of absolute lean body mass (LBM measured in kg)	LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).	Baseline - 6 weeks - 12 weeks
Change of step count per day	Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)	daily for 12 weeks starting with the first day of the intervention period

Collaborators and Investigators

• Sponsor: University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: exercise; quality of life; exercise therapy; heart rate variability; inflammatory markers; endurance training; concurrent training; physical peformance; concentration performance
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 00726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No