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

NCT05204511 | Completed

• 1 other identifier: 00726
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change of maximum lower body isometric muscle strength (measured in N)

  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

Study Arms (3)

Post-COVID/Long-COVID endurance training group

EXPERIMENTAL

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

Other: endurance training

Post-COVID/Long-COVID concurrent training group

EXPERIMENTAL

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

Other: concurrent training

Post-COVID/Long-COVID control group

NO INTERVENTION

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

Interventions

endurance training OTHER

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

Post-COVID/Long-COVID endurance training group

concurrent training OTHER

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

Post-COVID/Long-COVID concurrent training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

Department of Sport Science, University of Vienna

Vienna, 1150, Austria

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Motor Activity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: January 24, 2022
• Study Start: February 10, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)