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

NCT05853055 | Completed DMC

• 1 other identifier: 5213.00284
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Related Fatigue

Keywords

Self-reported fatigue; Fatigue questionnaires; Continous monitoring of physiological signals; Predictive model for fatigue condition; Respiratory training

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (18)

• Functional assessment by means of the hand grip test

  baseline

• Functional assessment by means of the hand grip test

  after 12 weeks of rehabilitation

• Functional assessment by means of the time up and go test

  baseline

• Functional assessment by means of the time up and go test

  after 12 weeks of rehabilitation

• Functional assessment by means of the 6 min walking test

  baseline

Study Arms (2)

Post-COVID-19 (respiratory training and monitoring)

EXPERIMENTAL

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

Post-COVID-19 (control and monitoring)

NO INTERVENTION

Patients receive the same therapeutical interventions as the Post-COVID19 respiratory training arm excluding respiratory training.

Interventions

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.

Post-COVID-19 (respiratory training and monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Annaheim: lead
• Kliniken Valens, Klinik Gais: collaborator

Study Sites (1)

Klinik Gais

Gais, 9056, Switzerland

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Simon Annaheim, Dr.

  Empa, Swiss Federal Laboratories for Materials Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Groupleader Materials-Body-Interaction Group

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 10, 2023
• Study Start: February 9, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available upon publication of the data Data will be available for an unlimited period of time
• 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.

Locations

CH (1)