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

NCT06073002 | Active Not Recruiting

• 1 other identifier: 01017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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.

  at baseline and at 12 weeks

Secondary Outcomes (11)

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

  at baseline and at 12 weeks

• Change of maximum hand grip strength (measured in kg)

  at baseline and at 12 weeks

• Change of Standard Deviation of RR-Intervals (SDNN measured in ms)

  at baseline and at 12 weeks

• Change of Root Mean Square of Successive Differences (RMSSD measured in ms)

  at baseline and at 12 weeks

• Change of health-related quality of life (HQoL) assessed via the SF-36 1.0

  at baseline an at 12 weeks

Study Arms (1)

Home-based concurrent training

EXPERIMENTAL

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

Interventions

home-based concurrent exercise OTHER

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.

Home-based concurrent training

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 Long-COVID

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)
• 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 and Human Movement Science

Vienna, Vienna, 1150, Austria

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

COVID-19; 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

Study Design

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

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 10, 2023
• Study Start: September 4, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)