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

NCT ID: NCT05853055

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-07-12

Brief Summary

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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

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Conditions

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Post-COVID-19 Related Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Respiratory training

Intervention Type 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 (control and monitoring)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kliniken Valens, Klinik Gais

UNKNOWN

Sponsor Role collaborator

Simon Annaheim

OTHER

Sponsor Role lead

Responsible Party

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Simon Annaheim

Scientific Groupleader Materials-Body-Interaction Group

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Simon Annaheim, Dr.

Role: PRINCIPAL_INVESTIGATOR

Empa, Swiss Federal Laboratories for Materials Science and Technology

Locations

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Klinik Gais

Gais, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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5213.00284

Identifier Type: -

Identifier Source: org_study_id

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