Post-COVID-19 Related Fatigue
Conditions
Keywords
Self-reported fatigue, Fatigue questionnaires, Continous monitoring of physiological signals, Predictive model for fatigue condition, Respiratory training
Brief summary
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.
Interventions
PROCEDURERespiratory training
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.
Sponsors
Kliniken Valens, Klinik Gais
Simon Annaheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The study population comprises 20 patients suffering from post-COVID-19, since fatigue is a major complaint in this condition. Since abnormal breathing patterns during exertion occur mainly in post-COVID-19 patients, only these will participate in the respiratory training intervention. Half of the post-COVID-19 patients will be the control, and the other half the intervention group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years old) * suffering from post-COVID-19 fatigue (i.e., score equal or higher than 5 on the single-item fatigue \[SIF\] or the Fatigue Severity Scale \[FSS\]) * admitted to Gais rehabilitation clinic * able to use a mobile phone * able to wear and handle the monitoring devices
Exclusion criteria
* Patients suffering from a relevant comorbidity (i.e., comorbidity resulting in significant distortion of physiological signals \[e.g., moderate to severe chronic obstructive pulmonary disease or persistent atrial fibrillation\]) * pregnancy * unable to use, wear or handle the monitoring systems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory exchange ratio at anaerobic threshold | baseline | 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). |
| Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire | baseline | 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. |
| Heart rate | baseline | Heart rate (in beats per minute) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA) |
| Heart rate variability | baseline | Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA) |
| Breathing rate | baseline | Breathing rate (in breaths per minute) will be obtained from breathing waveform signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA) |
| Physical activity intensity | baseline | 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) |
| Nocturnal blood oxygen saturation | baseline | Nocturnal blood oxygen saturation (in %) will be monitored continuously during night by Nonin Wristox2 3150 (Nonin Medical Inc., Minnesota, USA) |
| Breathing frequency at anaerobic threshold | baseline | 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). |
| Tidal volume at anaerobic threshold | baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue severity scale | baseline | 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) |
| Hospital Anxiety and Depression Scale | baseline | 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) |
| Health-related quality of life assessment by means of short form health survey (SF-36) | baseline | Questionnaire for the assessment of health-related quality of life (minimum value = 0, low quality of life; maximum value = 100, high quality of life) |
| Functional assessment by means of the hand grip test | baseline | 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. |
| Functional assessment by means of the time up and go test | baseline | 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. |
| Functional assessment by means of the 6 min walking test | baseline | Measurement of distance covered (in m) during 6 minutes of walking. |
| Bell Disability Scale | baseline | Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning) |
| Chronic Respiratory Disease Questionnaire | baseline | 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) |
| Edmonton Symptom Assessment System | baseline | Questionnaire for the assessment of cancer symptoms consisting of 10 items covering a range of 0 (no symptoms) and 10 (worst symptoms) |
Countries
Switzerland
Outcome results
None listed