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

October 9, 2023 updated by: Daniel König, University of Vienna

Effects of a Home-Based Exercise Intervention on Physical Function, Symptoms and Health-Related Quality of Life in Subjects With Long Covid

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1150
        • Recruiting
        • Department of Sport and Human Movement Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • 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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based concurrent training
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
Other: home-based concurrent exercise
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.

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)
Time Frame: at baseline and at 12 weeks
VO2peak will be assessed during cardio pulmonary exercise testing (CPET) on a bicycle ergometer.
at baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of maximum lower body isometric muscle strength (measured in N)
Time Frame: at baseline and at 12 weeks
Maximum lower body isometric muscle strength will be assessed via a leg press with integrated isometric force measurement (Compass 530, Suessmed GmbH).
at baseline and at 12 weeks
Change of maximum hand grip strength (measured in kg)
Time Frame: at baseline and at 12 weeks
Maximum hand grip strength will be assessed via a hand grip dynamometer (Saehan SH5001).
at baseline and at 12 weeks
Change of Standard Deviation of RR-Intervals (SDNN measured in ms)
Time Frame: at baseline and at 12 weeks
SDNN will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
at baseline and at 12 weeks
Change of Root Mean Square of Successive Differences (RMSSD measured in ms)
Time Frame: at baseline and at 12 weeks
RMSSD will be assessed via a short-term heart rate variability (HRV) measurement (BioSign).
at baseline and at 12 weeks
Change of health-related quality of life (HQoL) assessed via the SF-36 1.0
Time Frame: at baseline an at 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.
at baseline an at 12 weeks
Change of the number of present Long-COVID specific symptoms
Time Frame: at baseline and at 12 weeks
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.
at baseline and at 12 weeks
Change of fatigue assessed via the Fatigue Severity Scale (FSS)
Time Frame: at baseline and at 12 weeks
The FSS is a 9-item self-report questionnaire using a 1-7 Likert-scale
at baseline and at 12 weeks
Change of dyspnoea assessed via the modified Medical Research Council (mMRC) dyspnoea scale
Time Frame: at baseline and at 12 weeks
The mMRC dyspnoea scale measures perceived breathlessness and classifies subjects into dyspnoea grades from 0-4.
at baseline and at 12 weeks
Change of interleukin-6 (IL-6 measured in pg/ml)
Time Frame: at baseline and at 12 weeks
IL-6 will be assessed via blood sample.
at baseline and at 12 weeks
Change of tumor necrosis factor alpha (TNF-α measured in pg/ml)
Time Frame: at baseline and at 12 weeks
TNF-α will be assessed via blood sample.
at baseline and at 12 weeks
Change of mean time "correct rejection" (CR, speed during concentrated working measured in s)
Time Frame: at baseline and at 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.
at baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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