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

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 Overview

• Status: Recruiting
• Conditions: Post-COVID-19 Related Fatigue
• Intervention / Treatment: Procedure: Respiratory training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neusa R. Adao Martins, MSc.; Phone Number: +41 58 765 76 33; Email: neusa.martins@empa.ch

Study Locations

• Switzerland
  • Gais, Switzerland, 9056
    • Recruiting
    • Klinik Gais
    • Contact: Jean-Paul Schmid, Dr.; Phone Number: +41 58 511 22 25; Email: Jean-Paul.Schmid@kliniken-valens.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post-COVID-19 (respiratory training and monitoring); 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.	Procedure: Respiratory 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.
No Intervention: Post-COVID-19 (control and monitoring); Patients receive the same therapeutical interventions as the Post-COVID19 respiratory training arm excluding respiratory training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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).	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).	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).	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).	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).	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).	after 12 weeks of rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	baseline
Functional assessment by means of the 6 min walking test	Measurement of distance covered (in m) during 6 minutes of walking.	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)	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)	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)	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)	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)	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)	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)	baseline
Bell Disability Scale	Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)	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)	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)	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)	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)	after 12 weeks of rehabilitation

Collaborators and Investigators

• Sponsor: Simon Annaheim
• Collaborators: Kliniken Valens, Klinik Gais
• Investigators: Principal Investigator: Simon Annaheim, Dr., Empa, Swiss Federal Laboratories for Materials Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory training; Self-reported fatigue; Fatigue questionnaires; Continous monitoring of physiological signals; Predictive model for fatigue condition
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 5213.00284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is intended to publish the study in an open-access journal by December 2024. With this, the raw data of the physiological parameters measured and the self-reported data about fatigue symptoms (questionnaires) will be made available upon request and fulfilling the access criteria as indicated below.
• IPD Sharing Time Frame: Data will be available upon publication of the data Data will be available for an unlimited period of time
• IPD Sharing Access Criteria: Data will be made available upon request for scientific analysis of the data. Research objectives and data analysis plan needs to be provided.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No