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Completed

NCT Number: NCT05853055

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

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.

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Key information

Conditions

Post-COVID-19 Related Fatigue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Gais

Gais, 9056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory training

Procedure

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.

Primary outcomes

  1. Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire

    Time frame: 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.

  2. Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire

    Time frame: 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.

  3. Heart rate

    Time frame: baseline

    Heart rate (in beats per minute) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)

  4. Heart rate

    Time frame: 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)

  5. Heart rate variability

    Time frame: baseline

    Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)

  6. Heart rate variability

    Time frame: 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)

  7. Breathing rate

    Time frame: 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)

  8. Breathing rate

    Time frame: 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)

  9. Physical activity intensity

    Time frame: 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)

  10. Physical activity intensity

    Time frame: 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)

  11. Nocturnal blood oxygen saturation

    Time frame: baseline

    Nocturnal blood oxygen saturation (in %) will be monitored continuously during night by Nonin Wristox2 3150 (Nonin Medical Inc., Minnesota, USA)

  12. Nocturnal blood oxygen saturation

    Time frame: 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)

  13. Breathing frequency at anaerobic threshold

    Time frame: 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).

  14. Breathing frequency at anaerobic threshold

    Time frame: 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).

  15. Tidal volume at anaerobic threshold

    Time frame: 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).

  16. Tidal volume at anaerobic threshold

    Time frame: 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).

  17. Respiratory exchange ratio at anaerobic threshold

    Time frame: 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).

  18. Respiratory exchange ratio at anaerobic threshold

    Time frame: 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 outcomes

  1. Functional assessment by means of the hand grip test

    Time frame: 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.

  2. Functional assessment by means of the hand grip test

    Time frame: 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.

  3. Functional assessment by means of the time up and go test

    Time frame: 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.

  4. Functional assessment by means of the time up and go test

    Time frame: 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.

  5. Functional assessment by means of the 6 min walking test

    Time frame: baseline

    Measurement of distance covered (in m) during 6 minutes of walking.

  6. Functional assessment by means of the 6 min walking test

    Time frame: after 12 weeks of rehabilitation

    Measurement of distance covered (in m) during 6 minutes of walking.

  7. Fatigue severity scale

    Time frame: 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)

  8. Fatigue severity scale

    Time frame: 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)

  9. Health-related quality of life assessment by means of short form health survey (SF-36)

    Time frame: 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)

  10. Health-related quality of life assessment by means of short form health survey (SF-36)

    Time frame: 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)

  11. Hospital Anxiety and Depression Scale

    Time frame: 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)

  12. Hospital Anxiety and Depression Scale

    Time frame: 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)

  13. Bell Disability Scale

    Time frame: baseline

    Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)

  14. Bell Disability Scale

    Time frame: 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)

  15. Chronic Respiratory Disease Questionnaire

    Time frame: 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)

  16. Chronic Respiratory Disease Questionnaire

    Time frame: 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)

  17. Edmonton Symptom Assessment System

    Time frame: baseline

    Questionnaire for the assessment of cancer symptoms consisting of 10 items covering a range of 0 (no symptoms) and 10 (worst symptoms)

  18. Edmonton Symptom Assessment System

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Simon Annaheim

Other

Collaborators

  • Kliniken Valens, Klinik Gais

Registry information

Acronym: Fatignals

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2023
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.