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Effects of a Home-Based Exercise Intervention in Subjects With Long COVID

Primary Purpose

Long COVID-19, Post-COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
home-based concurrent exercise
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, concurrent training, exercise rehabilitation, Long COVID-19, Post-COVID-19 Syndrome, home-based training

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 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)

Sites / Locations

  • Department of Sport and Human Movement ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based concurrent training

Arm Description

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

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 short-term heart rate variability (HRV) measurement (BioSign).
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 the number of present Long-COVID specific symptoms
The number of 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 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 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.

Full Information

First Posted
October 6, 2023
Last Updated
October 9, 2023
Sponsor
University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT06073002
Brief Title
Effects of a Home-Based Exercise Intervention in Subjects With Long COVID
Official Title
Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects With Long Covid
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

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 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.

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
Keywords
exercise, exercise therapy, concurrent training, exercise rehabilitation, Long COVID-19, Post-COVID-19 Syndrome, home-based training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based concurrent training
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
home-based concurrent exercise
Intervention Description
3 weekly sessions of home-based concurrent exercise on non-consecutive days. Resistance exercise is comprised of lunges, hip thrusts, pushups, resistance band rows, core and performed for 3 sets with 15-20 repetitions at an RPE of 14-18 (6-20 BORG scale). Endurance exercise can be done by the mode of choice and is monitored by heartrate zones. Sessions are of low to moderate intensity (below VT2) and the duration will be slowly increased for 20-40min.
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
at baseline and at 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
at baseline and at 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
at baseline and at 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
at baseline and at 12 weeks
Title
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
Description
RMSSD will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
Time Frame
at baseline and at 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
at baseline an at 12 weeks
Title
Change of the number of present Long-COVID specific symptoms
Description
The number of 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
at baseline and at 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
at baseline and at 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
at baseline and at 12 weeks
Title
Change of interleukin-6 (IL-6 measured in pg/ml)
Description
IL-6 will be assessed via blood sample.
Time Frame
at baseline and at 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
at baseline and at 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
at baseline and at 12 weeks

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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Sick, MSc
Phone
+43-1-4277-59118
Email
johanna.sick@univie.ac.at
Facility Information:
Facility Name
Department of Sport and Human Movement Science
City
Vienna
ZIP/Postal Code
1150
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Sick, MSc
Phone
+43-1-4277-59118
Email
johanna.sick@univie.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of a Home-Based Exercise Intervention in Subjects With Long COVID

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