Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin

Not Applicable

Completed

• Conditions: Post-COVID-19 Related Fatigue
• Interventions: Procedure: Respiratory training

• Registration Number: NCT05853055
• Lead Sponsor: Simon Annaheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-09
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Primary Completion: 2024-07-12
• Study Completion: 2024-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-COVID-19 (respiratory training and monitoring)	Respiratory training	Post-COVID-19 patients allocated to this arm get an additional respiratory training added to their conventional rehabilitation program. Patients will train twice daily for the length of their rehabilitation stay. An incentive spirometer (Voldyne 5000 R, Sherwood Medical, St. Louis, USA) will be used to complete training sessions of 15 mins each.

Primary Outcome Measures

Name	Time	Method
Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire	after 12 weeks of rehabilitation	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.
Tidal volume at anaerobic threshold	after 12 weeks of rehabilitation	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).
Physical activity intensity	after 12 weeks of rehabilitation	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)
Heart rate	after 12 weeks of rehabilitation	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	after 12 weeks of rehabilitation	Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Breathing rate	after 12 weeks of rehabilitation	Breathing rate (in breaths per minute) will be obtained from breathing waveform signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Nocturnal blood oxygen saturation	after 12 weeks of rehabilitation	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	after 12 weeks of rehabilitation	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).
Respiratory exchange ratio at anaerobic threshold	after 12 weeks of rehabilitation	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).

Secondary Outcome Measures

Name	Time	Method
Functional assessment by means of the hand grip test	after 12 weeks of rehabilitation	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	after 12 weeks of rehabilitation	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.
Fatigue severity scale	after 12 weeks of rehabilitation	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)
Functional assessment by means of the 6 min walking test	after 12 weeks of rehabilitation	Measurement of distance covered (in m) during 6 minutes of walking.
Health-related quality of life assessment by means of short form health survey (SF-36)	after 12 weeks of rehabilitation	Questionnaire for the assessment of health-related quality of life (minimum value = 0, low quality of life; maximum value = 100, high quality of life)
Chronic Respiratory Disease Questionnaire	after 12 weeks of rehabilitation	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	after 12 weeks of rehabilitation	Questionnaire for the assessment of cancer symptoms consisting of 10 items covering a range of 0 (no symptoms) and 10 (worst symptoms)
Hospital Anxiety and Depression Scale	after 12 weeks of rehabilitation	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)
Bell Disability Scale	after 12 weeks of rehabilitation	Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)

Trial Locations

Locations (1)

Klinik Gais; 🇨🇭 Gais, Switzerland