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Aerobic Training for Rehabilitation of Patients With Post Covid-19 Syndrome

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Aerobic Exercise Training
Sponsored by
University of Witten/Herdecke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring COVID-19, Fatigue, Rehabilitation, Exercise Training, Infectious Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: a history of (at least one) Covid-19 infection ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment referral to inpatient rehabilitation signed informed consent Exclusion Criteria: unstable condition incapable of understanding study information

Sites / Locations

  • Clinic Königsfeld

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous aerobic training

Interval aerobic training

Arm Description

Moderate continous endurance training, ergometer

Moderate intensity interval training, ergometer

Outcomes

Primary Outcome Measures

Change in Cardiorespiratory Fitness (CRF)
CRF will be measured as peak oxygen uptake (VO2peak) determined by spiroergometry

Secondary Outcome Measures

Change in Submaximal Cardiorespiratory Fitness (CRF)
Submaximal CRF will be measured as submaximal oxygen uptake (VO2 at ventilatory threshold 1 [VT1]) determined by spiroergometry
Change in Fatigue
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Work requirements and workload
Work requirements and workload will be assessed using the "Workability Index (WAI)".
Change Health-related quality of life
Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
Wellbeing
Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Change in Depression and Anxiety
Depression and Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
August 28, 2023
Last Updated
August 29, 2023
Sponsor
University of Witten/Herdecke
Collaborators
Institut für Rehabilitationsforschung Norderney
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1. Study Identification

Unique Protocol Identification Number
NCT06016192
Brief Title
Aerobic Training for Rehabilitation of Patients With Post Covid-19 Syndrome
Official Title
Medical Rehabilitation of Patients With Long-term Post-Covid-19 Syndrome - a Comparison of Aerobic Interval and Continuous Training
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Witten/Herdecke
Collaborators
Institut für Rehabilitationsforschung Norderney

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
Post-COVID-19 syndrome (PCS) occurs as a sequelae after acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is defined as symptom persistence over a period of 12 weeks from infection and/or the appearance of new symptoms in this period. While the majority of affected patients experience a gradual healing process without targeted treatment, the need for effective medical rehabilitation is high at least for patients with persistent PCS. Given that physical exercise has been shown to be beneficial in multiple pathologies such as cardiovascular diseases, neuropathic disorders, and pulmonary diseases it has been suggested that physical exercise including aerobic training could exert beneficial effects also in PCS. This study aims to analyse the use of moderate-intensity aerobic exercise training for medical rehabilitation of PCS patients.
Detailed Description
Post-COVID-19 syndrome (PCS) is a condition that occurs following an acute infection with the SARS-CoV-2 virus (COVID-19). PCS is characterized by symptom persistence for at least 12 weeks after the infection or the emergence of new symptoms during this period. Current guidelines propose several criteria for diagnosing PCS, including persistent symptoms from the acute COVID-19 phase, new symptoms leading to health limitations, symptoms assumed to be related to COVID-19 after the acute phase, and worsening of pre-existing underlying conditions. PCS is a complex and multisystemic disorder, with symptoms ranging from chronic fatigue, decreased physical performance, muscular weakness, and pain to cognitive impairment (often referred to as brain fog) and mental and psychological distress resembling a post-traumatic stress reaction. The exact causes of PCS are not fully understood but may involve processes such as endothelial dysfunction, cytokine storm, and increased oxidative stress affecting various organs and structures in the body. The incidence of PCS varies depending on the population studied and the severity of symptoms considered, with estimates ranging from 7.5% to 41% among non-hospitalized patients with acute infection. Medical rehabilitation is essential for patients with persistent PCS, but there are limited studies on its efficacy, especially in the context of aerobic endurance training. Physical exercise, including aerobic training, has shown positive effects in various diseases, and it is suggested that it may be beneficial for PCS as well. However, there is limited evidence regarding the effectiveness of aerobic endurance training in reducing the burden of decreased physical performance in PCS. Moreover, there is a lack of guidelines for PCS patients related to exercise-based rehabilitation. Aerobic endurance training has been proven to have positive effects on multiple physiological functions and is recommended for chronic heart and pulmonary diseases. Studies have also suggested that aerobic interval training may be advantageous for PCS patients, as it reduces ventilatory demand and may alleviate dyspnea and breathing effort. This study aims to investigate the efficacy of moderate-intensity aerobic endurance training performed as either continuous training and interval training for the medical rehabilitation of PCS patients. The study will include PCS patients referred for inpatient medical rehabilitation in Germany with a history of (at least one) Covid-19 infection and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment. Performance deficits will be documented according to the recent consensus statement, with the cluster of lead symptoms including fatigue/exercise intolerance, shortness of breath, and cognitive dysfunction impairing activity of daily living and everyday functioning. A detailed clinical workup will be performed, and the history of comorbidities and current medication will be documented. After admission, patients will be randomized to a continuous training (CT) or interval training (IT) group. Patients will receive individual medical rehabilitation including a combination of strength, respiratory and cognitive training, as well as physio-, psycho- and nutrition therapy, unaltered for both groups. Data on medical rehabilitation including prescriptions of therapeutic actions and participation will be recorded for all patients. Symptom-limited spiroergometry at admission and after 4-6 weeks of inpatient rehabilitation (before discharge) will be performed to analyze improvements in exercise capacity. Validated questionnaires will be used to document patients' disease perception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome, Long-COVID-19 Syndrome
Keywords
COVID-19, Fatigue, Rehabilitation, Exercise Training, Infectious Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous aerobic training
Arm Type
Active Comparator
Arm Description
Moderate continous endurance training, ergometer
Arm Title
Interval aerobic training
Arm Type
Experimental
Arm Description
Moderate intensity interval training, ergometer
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise Training
Intervention Description
Physical activity performed as controlled aerobic exercise training on ergometer
Primary Outcome Measure Information:
Title
Change in Cardiorespiratory Fitness (CRF)
Description
CRF will be measured as peak oxygen uptake (VO2peak) determined by spiroergometry
Time Frame
Baseline and week 4 (i. e. before discharge)
Secondary Outcome Measure Information:
Title
Change in Submaximal Cardiorespiratory Fitness (CRF)
Description
Submaximal CRF will be measured as submaximal oxygen uptake (VO2 at ventilatory threshold 1 [VT1]) determined by spiroergometry
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Change in Fatigue
Description
Fatigue will be assessed using the "The Multidimensional Fatigue Inventory (MFI20)".
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Work requirements and workload
Description
Work requirements and workload will be assessed using the "Workability Index (WAI)".
Time Frame
Baseline
Title
Change Health-related quality of life
Description
Health-related quality of life will be assessed using the "RAND 36-Item Health Survey (SF-36)".
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Wellbeing
Description
Wellbeing will be assessed using the "WHO-5 Well-Being Index".
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Change in Depression and Anxiety
Description
Depression and Anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline and week 4 (i. e. before discharge)
Other Pre-specified Outcome Measures:
Title
Change in training load
Description
Training load will be assessed by analysis of documented ergometer settings (mean Watts)
Time Frame
Daily, from baseline to week 4 (i. e. before discharge)
Title
Training participation
Description
Training participation will be assessed by number of performed ergometer training sessions
Time Frame
Daily, from baseline to week 4 (i. e. before discharge)
Title
Change in minute ventilation (VE)
Description
Minute ventilation will be determined by spiroergometry measuring breath-by-breath volumes (ml)
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Change in carbon dioxide production (VCO2)
Description
Carbon dioxide production (VCO2) will be determined by spiroergometry measuring breath-by-breath volumes of exhaled carbon dioxide (ml)
Time Frame
Baseline and week 4 (i. e. before discharge)
Title
Change in submaximal and maximal workload (Watt)
Description
Submaxmal and maximal workload (Watt) will be determined by spiroergometry
Time Frame
Baseline and week 4 (i. e. before discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a history of (at least one) Covid-19 infection ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment referral to inpatient rehabilitation signed informed consent Exclusion Criteria: unstable condition incapable of understanding study information
Facility Information:
Facility Name
Clinic Königsfeld
City
Ennepetal
State/Province
NRW
ZIP/Postal Code
58256
Country
Germany

12. IPD Sharing Statement

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Aerobic Training for Rehabilitation of Patients With Post Covid-19 Syndrome

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