Clinical trial NCT05853055: Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin
Official title: Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Related Fatigue
Keywords: Self-reported fatigue
Fatigue questionnaires
Continous monitoring of physiological signals
Predictive model for fatigue condition
Respiratory training
Lead sponsor: Empa, Swiss Federal Laboratories for Materials Science and Technology
Sponsor class: OTHER
Collaborators: name: Kliniken Valens, Klinik Gais
First posted: 2023-05-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
timeFrame: baseline
measure: Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
timeFrame: after 12 weeks of rehabilitation
measure: Heart rate
timeFrame: baseline
measure: Heart rate
timeFrame: after 12 weeks of rehabilitation
measure: Heart rate variability
timeFrame: baseline
measure: Heart rate variability
timeFrame: after 12 weeks of rehabilitation
measure: Breathing rate
timeFrame: baseline
measure: Breathing rate
timeFrame: after 12 weeks of rehabilitation
measure: Physical activity intensity
timeFrame: baseline
measure: Physical activity intensity
timeFrame: after 12 weeks of rehabilitation
measure: Nocturnal blood oxygen saturation
timeFrame: baseline
measure: Nocturnal blood oxygen saturation
timeFrame: after 12 weeks of rehabilitation
measure: Breathing frequency at anaerobic threshold
timeFrame: baseline
measure: Breathing frequency at anaerobic threshold
timeFrame: after 12 weeks of rehabilitation
measure: Tidal volume at anaerobic threshold
timeFrame: baseline
measure: Tidal volume at anaerobic threshold
timeFrame: after 12 weeks of rehabilitation
measure: Respiratory exchange ratio at anaerobic threshold
timeFrame: baseline
measure: Respiratory exchange ratio at anaerobic threshold
timeFrame: after 12 weeks of rehabilitation
Secondary outcomes:
measure: Functional assessment by means of the hand grip test
timeFrame: baseline
measure: Functional assessment by means of the hand grip test
timeFrame: after 12 weeks of rehabilitation
measure: Functional assessment by means of the time up and go test
timeFrame: baseline
measure: Functional assessment by means of the time up and go test
timeFrame: after 12 weeks of rehabilitation
measure: Functional assessment by means of the 6 min walking test
timeFrame: baseline
measure: Functional assessment by means of the 6 min walking test
timeFrame: after 12 weeks of rehabilitation
measure: Fatigue severity scale
timeFrame: baseline
measure: Fatigue severity scale
timeFrame: after 12 weeks of rehabilitation
measure: Health-related quality of life assessment by means of short form health survey (SF-36)
timeFrame: baseline
measure: Health-related quality of life assessment by means of short form health survey (SF-36)
timeFrame: after 12 weeks of rehabilitation
measure: Hospital Anxiety and Depression Scale
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: after 12 weeks of rehabilitation
measure: Bell Disability Scale
timeFrame: baseline
measure: Bell Disability Scale
timeFrame: after 12 weeks of rehabilitation
measure: Chronic Respiratory Disease Questionnaire
timeFrame: baseline
measure: Chronic Respiratory Disease Questionnaire
timeFrame: after 12 weeks of rehabilitation
measure: Edmonton Symptom Assessment System
timeFrame: baseline
measure: Edmonton Symptom Assessment System
timeFrame: after 12 weeks of rehabilitation
Other outcomes:
Locations:
city: Gais
country: Switzerland
facility: Klinik Gais
Study officials:
affiliation: Empa, Swiss Federal Laboratories for Materials Science and Technology
name: Simon Annaheim, Dr.
role: PRINCIPAL_INVESTIGATOR
References: