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

Simon Annaheim

Status: Completed

Conditions: Post-COVID-19 Related Fatigue

Treatments: Procedure: Respiratory training

Study type: Interventional

Funder types: Other

Identifiers

NCT05853055

5213.00284

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Post-COVID-19 (respiratory training and monitoring)

Experimental group

Description:

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.

Treatment:

Procedure: Respiratory training

Post-COVID-19 (control and monitoring)

No Intervention group

Description:

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