This study investigates the use of physiological parameters as predictors of disease-related fatigue. For that purpose, wearable devices are used to monitor post-COVID-19 patients during their stay in a rehabilitation clinic. Besides, the effectiveness of respiratory training in reducing breathlessness and improving exercise breathing patterns in patients suffering from post-COVID-19 will be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
33
Respiratory training will be included in the rehabilitation program of a subgroup of post-COVID-19 patients. The intervention group will train twice daily for the length of their rehabilitation stay using an incentive spirometer (Voldyne 5000 R, Sherwood Medical, St. Louis, USA). Subjects will be instructed to first completely exhale slowly. Then inspire slowly up to 70% of their vital capacity, producing a constant flow controlled via feedback from the device. This procedure will be repeated every 30 s (paced by a metronome) for 15 min. The training will be conducted twice a day, resulting in a total of 60 inspirations per day.
Klinik Gais
Gais, Switzerland
Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
The single item fatigue (SIF) questionnaire is a multidimensional questionnaire developed for use in daily clinical practice. It has 5-items covering global fatigue, cognitive fatigue, emotional fatigue, physical fatigue, fatigue relief by sleep), each consisting of an 11-point likert scale (0 \[no fatigue\] to 10 \[severe fatigue\]), . Perceived fatigue was asked for the past 24 hours.
Time frame: baseline
Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
The single item fatigue (SIF) questionnaire is a multidimensional questionnaire developed for use in daily clinical practice. It has 5-items covering global fatigue, cognitive fatigue, emotional fatigue, physical fatigue, fatigue relief by sleep), each consisting of an 11-point likert scale (0 \[no fatigue\] to 10 \[severe fatigue\]), . Perceived fatigue was asked for the past 24 hours.
Time frame: after 12 weeks of rehabilitation
Heart rate
Heart rate (in beats per minute) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: baseline
Heart rate
Heart rate (in beats per minute) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: after 12 weeks of rehabilitation
Heart rate variability
Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: baseline
Heart rate variability
Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
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Time frame: after 12 weeks of rehabilitation
Breathing rate
Breathing rate (in breaths per minute) will be obtained from breathing waveform signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: baseline
Breathing rate
Breathing rate (in breaths per minute) will be obtained from breathing waveform signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: after 12 weeks of rehabilitation
Physical activity intensity
The mean amplitude observed for the resultant acceleration (based on 3D acceleration measurements in g) is considered to be representative for the physical activity intensity. It will be obtained from acceleration measurements monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: baseline
Physical activity intensity
The mean amplitude observed for the resultant acceleration (based on 3D acceleration measurements in g) is considered to be representative for the physical activity intensity. It will be obtained from acceleration measurements monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Time frame: after 12 weeks of rehabilitation
Nocturnal blood oxygen saturation
Nocturnal blood oxygen saturation (in %) will be monitored continuously during night by Nonin Wristox2 3150 (Nonin Medical Inc., Minnesota, USA)
Time frame: baseline
Nocturnal blood oxygen saturation
Nocturnal blood oxygen saturation (in %) will be monitored continuously during night by Nonin Wristox2 3150 (Nonin Medical Inc., Minnesota, USA)
Time frame: after 12 weeks of rehabilitation
Breathing frequency at anaerobic threshold
Breathing frequency (in breaths per minute) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: baseline
Breathing frequency at anaerobic threshold
Breathing frequency (in breaths per minute) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: after 12 weeks of rehabilitation
Tidal volume at anaerobic threshold
Tidal volume (in ml) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: baseline
Tidal volume at anaerobic threshold
Tidal volume (in ml) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: after 12 weeks of rehabilitation
Respiratory exchange ratio at anaerobic threshold
Respiratory exchange ratio obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: baseline
Respiratory exchange ratio at anaerobic threshold
Respiratory exchange ratio obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Time frame: after 12 weeks of rehabilitation
Functional assessment by means of the hand grip test
Measurement of mean strength (in kg) by pulling a dynamometer handle with maximum force for 3 seconds using the dominant hand followed by 5 seconds of relaxation. Sequence in conducted 10 times.
Time frame: baseline
Functional assessment by means of the hand grip test
Measurement of mean strength (in kg) by pulling a dynamometer handle with maximum force for 3 seconds using the dominant hand followed by 5 seconds of relaxation. Sequence in conducted 10 times.
Time frame: after 12 weeks of rehabilitation
Functional assessment by means of the time up and go test
Measures the time (in s) required to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again; assesses the dynamic balance and functional mobility.
Time frame: baseline
Functional assessment by means of the time up and go test
Measures the time (in s) required to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again; assesses the dynamic balance and functional mobility.
Time frame: after 12 weeks of rehabilitation
Functional assessment by means of the 6 min walking test
Measurement of distance covered (in m) during 6 minutes of walking.
Time frame: baseline
Functional assessment by means of the 6 min walking test
Measurement of distance covered (in m) during 6 minutes of walking.
Time frame: after 12 weeks of rehabilitation
Fatigue severity scale
Questionnaire to evaluate the impact of fatigue with a minimum value of 9 (not suffering from fatigue at all) and a maximum value of 63 (highly affected by fatigue)
Time frame: baseline
Fatigue severity scale
Questionnaire to evaluate the impact of fatigue with a minimum value of 9 (not suffering from fatigue at all) and a maximum value of 63 (highly affected by fatigue)
Time frame: after 12 weeks of rehabilitation
Health-related quality of life assessment by means of short form health survey (SF-36)
Questionnaire for the assessment of health-related quality of life (minimum value = 0, low quality of life; maximum value = 100, high quality of life)
Time frame: baseline
Health-related quality of life assessment by means of short form health survey (SF-36)
Questionnaire for the assessment of health-related quality of life (minimum value = 0, low quality of life; maximum value = 100, high quality of life)
Time frame: after 12 weeks of rehabilitation
Hospital Anxiety and Depression Scale
Questionnaire for the assessment of anxiety and depression (minimum value = 0, no signs of anxiety and depression; maximum value = 10, highest levels of anxiety and depression)
Time frame: baseline
Hospital Anxiety and Depression Scale
Questionnaire for the assessment of anxiety and depression (minimum value = 0, no signs of anxiety and depression; maximum value = 10, highest levels of anxiety and depression)
Time frame: after 12 weeks of rehabilitation
Bell Disability Scale
Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)
Time frame: baseline
Bell Disability Scale
Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)
Time frame: after 12 weeks of rehabilitation
Chronic Respiratory Disease Questionnaire
Questionnaire for the assessment of dyspnoea (in post-COVID-10 patients) consisting of 5 items covering a range of 0 (worst condition) and 8 (best condition)
Time frame: baseline
Chronic Respiratory Disease Questionnaire
Questionnaire for the assessment of dyspnoea (in post-COVID-10 patients) consisting of 5 items covering a range of 0 (worst condition) and 8 (best condition)
Time frame: after 12 weeks of rehabilitation
Edmonton Symptom Assessment System
Questionnaire for the assessment of cancer symptoms consisting of 10 items covering a range of 0 (no symptoms) and 10 (worst symptoms)
Time frame: baseline
Edmonton Symptom Assessment System
Questionnaire for the assessment of cancer symptoms consisting of 10 items covering a range of 0 (no symptoms) and 10 (worst symptoms)
Time frame: after 12 weeks of rehabilitation