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

Primary Purpose

Long COVID-19, Post-COVID-19 Syndrome, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
endurance training
concurrent training
Sponsored by
University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Long COVID-19 focused on measuring exercise, exercise therapy, endurance training, concurrent training, physical peformance, inflammatory markers, quality of life, concentration performance, heart rate variability

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Sport Science, University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Post-COVID/Long-COVID endurance training group

Post-COVID/Long-COVID concurrent training group

Post-COVID/Long-COVID control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Change of maximum hand grip strength (measured in kg)
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)
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)
RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)
hs-CRP will be assessed via blood sample.
Change of interleukin-6 (IL-6 measured in pg/ml)
IL-6 will be assessed via blood sample.
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
TNF-α will be assessed via blood sample.
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.
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.
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.
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
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.
Change of absolute body fat (BF measured in kg)
BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Change of absolute lean body mass (LBM measured in kg)
LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Change of step count per day
Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)

Full Information

First Posted
January 21, 2022
Last Updated
July 18, 2023
Sponsor
University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05204511
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-COVID/Long-COVID endurance training group
Arm Type
Experimental
Arm Description
Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly endurance training intervention
Arm Title
Post-COVID/Long-COVID concurrent training group
Arm Type
Experimental
Arm Description
Participants affected by Post-COVID/Long-COVID that carry out a 12-week thrice weekly concurrent training intervention
Arm Title
Post-COVID/Long-COVID control group
Arm Type
No Intervention
Arm Description
Participants affected by Post-COVID/Long-COVID that don't carry out an exercise intervention
Intervention Type
Other
Intervention Name(s)
endurance training
Intervention Description
endurance training of low to moderate intensity on a bicycle ergometer, crosstrainer or treadmill performed for 30-60 minutes per session
Intervention Type
Other
Intervention Name(s)
concurrent training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of peak oxygen consumption (VO2peak measured in ml/min/kg)
Description
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.
Time Frame
Baseline - 6 weeks - 12 weeks
Secondary Outcome Measure Information:
Title
Change of maximum lower body isometric muscle strength (measured in N)
Description
Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of maximum hand grip strength (measured in kg)
Description
Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
Description
SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
Description
RMSSD will be assessed via a respiratory sinus arrythmia measurement (BioSign).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of high-sensitive C-reactive protein (hs-CRP measured in mg/l)
Description
hs-CRP will be assessed via blood sample.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of interleukin-6 (IL-6 measured in pg/ml)
Description
IL-6 will be assessed via blood sample.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
Description
TNF-α will be assessed via blood sample.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
Description
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.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
Description
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.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of the number of present Post-COVID/Long-COVID specific symptoms
Description
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.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of fatigue assessed via the Fatigue Severity Scale (FSS)
Description
The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
Description
The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of absolute body fat (BF measured in kg)
Description
BF will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of absolute lean body mass (LBM measured in kg)
Description
LBM will be assessed via a bioelectrical impedance analysis (seca BCA01A).
Time Frame
Baseline - 6 weeks - 12 weeks
Title
Change of step count per day
Description
Step count will be assessed daily during the 12-week intervention period using a wearable device (Polar Unite)
Time Frame
daily for 12 weeks starting with the first day of the intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Department of Sport Science, University of Vienna
City
Vienna
ZIP/Postal Code
1150
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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