Post-COVID-19 Related FatigueFatignalsNCT05853055
Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin
A study testing Respiratory training in people with Post-COVID-19 Related Fatigue, run by Simon Annaheim at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Related Fatigue
- What is being tested?
- Respiratory training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Feb 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Respiratory training
- Keywords
- Self-reported fatigue, Fatigue questionnaires, Continous monitoring of physiological signals, Predictive model for fatigue condition, Respiratory training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: after 12 weeks of rehabilitation
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Functional assessment by means of the 6 min walking test
Measurement of distance covered (in m) during 6 minutes of walking.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline
Bell Disability Scale
Questionnaire for the assessment of the patient's overall functioning (minimum value = 0, worst functioning; maximum value = 100, best functioning)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: after 12 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start9 Feb 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Annaheim
- Sponsor type
- University, hospital or other
- Collaborators
- Kliniken Valens, Klinik Gais
- Responsible party
- Sponsor-investigator, Simon Annaheim, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Investigators
- Simon Annaheim, Dr., Principal investigator, Empa, Swiss Federal Laboratories for Materials Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853055
- Sponsor's protocol ID
- 5213.00284
- Acronym
- Fatignals
- Status last verified
- Jan 2025
- First submitted
- 22 Mar 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin
- ClinicalTrials.gov ID
- NCT05853055
- Acronym / sponsor ID
- Fatignals / 5213.00284
- Conditions
- Post-COVID-19 Related Fatigue
- Keywords
- Self-reported fatigue, Fatigue questionnaires, Continous monitoring of physiological signals, Predictive model for fatigue condition, Respiratory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Simon AnnaheimUniversity, hospital or other
- Collaborators
- Kliniken Valens, Klinik Gais
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 (respiratory training and monitoring) | Experimental | Procedure: Respiratory trainingPost-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. |
| Post-COVID-19 (control and monitoring) | No intervention | –Patients receive the same therapeutical interventions as the Post-COVID19 respiratory training arm excluding respiratory training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory trainingRespiratory 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. | Procedure or surgery | Post-COVID-19 (respiratory training and monitoring) |
Primary outcome
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.
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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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).
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).
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).
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).
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).
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).
18 secondary outcomes
Functional assessment by means of the hand grip test
Time frame: baseline
Functional assessment by means of the hand grip test
Time frame: after 12 weeks of rehabilitation
Functional assessment by means of the time up and go test
Time frame: baseline
Functional assessment by means of the time up and go test
Time frame: after 12 weeks of rehabilitation
Functional assessment by means of the 6 min walking test
Time frame: baseline
Functional assessment by means of the 6 min walking test
Time frame: after 12 weeks of rehabilitation
Fatigue severity scale
Time frame: baseline
Fatigue severity scale
Time frame: after 12 weeks of rehabilitation
Health-related quality of life assessment by means of short form health survey (SF-36)
Time frame: baseline
Health-related quality of life assessment by means of short form health survey (SF-36)
Time frame: after 12 weeks of rehabilitation
Hospital Anxiety and Depression Scale
Time frame: baseline
Hospital Anxiety and Depression Scale
Time frame: after 12 weeks of rehabilitation
Bell Disability Scale
Time frame: baseline
Bell Disability Scale
Time frame: after 12 weeks of rehabilitation
Chronic Respiratory Disease Questionnaire
Time frame: baseline
Chronic Respiratory Disease Questionnaire
Time frame: after 12 weeks of rehabilitation
Edmonton Symptom Assessment System
Time frame: baseline
Edmonton Symptom Assessment System
Time frame: after 12 weeks of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Annaheim, Dr. principal investigator
Empa, Swiss Federal Laboratories for Materials Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory training in people with Post-COVID-19 Related Fatigue, run by Simon Annaheim at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.