Long COVIDNCT05599906
Effects of Inpatient Rehabilitation Measures in Long-COVID-19 Syndrome
An observational study of Long COVID, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
Trial summary
The aim of the present study is to answer the question of whether a rehabilitation measure has a positive effect on fatigue symptoms, physical performance, and the physical and psychological well-being of the patients. In particular, the fatigue that occurs in most of all patients is of interest here. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- questionnaires
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 11 Oct 2021to Aug 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: patient with long/post-covid
Who may be able to join
- ≥ 18 years, written consent; inpatient stay in the participating rehabilitation clinic
Who cannot join
- lack of consent, Illnesses or functional disorders which, in the opinion of the investigator, exclude participation in this clinical trial (dementia, psychotic disorders)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Paracelsus Harzklinik Bad Suderode GmbH
Quedlinburg, 06485
Axel Schlitt, +493948599784, axel.schlitt@pkd.de
Viktoria Heinze, +493948599784, viktoria.heinze@pkd.de
About this study
The aim of the present study is to answer the question of whether a rehabilitation measure has a positive effect on fatigue symptoms, physical performance, and the physical and psychological well-being of the patients. In particular, the fatigue that occurs in most of all patients is of interest here. In order to make this measurable, the FAS questionnaire plays a special role, which should be completed by all 100 patients upon inclusion in the study and upon discharge from the rehabilitation clinic. In addition, the HADS-D questionnaire (Hospital Anxiety and Depression Scale) for self-assessment of depressive symptoms and anxiety symptoms and the SF-12 questionnaire (Short Form Health Survey) are used as a screening tool to assess health-related quality of life.
For the clinical examination of physical performance, the six-minute walk test, a body plethysmography and a long-term ECG are performed on recruited patients on admission and before discharge. In a three-month follow-up, all recruited patients should receive an FAS, HADS-D and SF-12 questionnaire to fill out. Some of these will also be called back to the clinic to check the development of lung function or performance, defined on the basis of VO2max, and will undergo an additional spiroergometric examination.
Thus, the effectiveness and effectiveness of the rehabilitation measures in patients under long-COVID is checked.
Read the detailed description
The study is a prospective, monocentric cohort study in which patients with the main diagnosis of long-COVID syndrome from the Paracelsus Harz Clinic, Bad Suderode, are included and followed up over a period of three months.
The study population consists of patients from the rehabilitation clinic Paracelsus-Harz-Klinik Bad Suderode. It is planned to enroll 100 patients, all of whom will be included in a three-month follow-up. Within this follow-up, 20 of the 100 patients will be selected to be re-examined in the clinic three months later. For this purpose, patients are selected who live within a maximum distance of 50km from the Paracelsus Harz Clinic and who are able to reach the clinic three months after completion of the rehabilitation measure.
After receiving the vote of the Ethics Committee of the Medical Association of the State of Saxony-Anhalt (Bad Suderode) and the written consent of the patients, socio-demographic information and questions are documented according to the standard of the rehabilitation clinic. All relevant baseline parameters (age, gender, BMI, drug treatment, etc.) are also documented. In order to obtain the essential values for the evaluation of the physical and psychological condition of the patients, all patients receive an FAS questionnaire, a HADS-D and an SF-12 questionnaire upon inclusion and at the end of the rehabilitation stay. Furthermore, after admission and before discharge, a six-minute walk test, a lung function test using body plethysmography and a long-term ECG for cardiological observation are carried out.
After the patients have left the clinic, 80 of the recruited patients will be contacted by post three months later in order to fill out the previously known questionnaires again. The Fatigue Questionnaire (FAS Questionnaire) is of particular interest for checking the physical and psychological development after completion of the rehabilitation treatment. In addition, the patients should again receive the HADS-D and SF-12 questionnaires to check their mental and physical well-being. If the patients cannot be reached, an attempt is made to obtain follow-up information by telephone, relatives or general practitioners. The remaining 20 patients will be referred to the clinic again as part of the three-month follow-up so that the development of lung function and performance, measured using VO2max, can be checked in the form of spiroergometry. During their stay, they also receive the FAS questionnaire, the HADS-D and the SF-12 questionnaire to fill out
- Conditions
- Long COVID
- Being tested
- questionnaires
- Keywords
- long covid
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Completion of 3 questionnaires (HADS; SF-12; FAS) at the beginning and end of the rehabilitation and after 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of fatigue symptoms measured with the FAS score
Analysis of the questionnaires
Measured: Day one
Course of fatigue symptoms measured with the FAS score
Analysis of the questionnaires
Measured: after 3 weeks
Course of fatigue symptoms measured with the FAS score
Analysis of the questionnaires
Measured: after 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start11 Oct 2021
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599906
- Sponsor's protocol ID
- 96/21
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inpatient Rehabilitation Measures in Long-COVID-19 Syndrome
- ClinicalTrials.gov ID
- NCT05599906
- Acronym / sponsor ID
- 96/21
- Conditions
- Long COVID
- Keywords
- long covid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.University, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 31 Oct 2022 (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.
The aim of the present study is to answer the question of whether a rehabilitation measure has a positive effect on fatigue symptoms, physical performance, and the physical and psychological well-being of the patients. In particular, the fatigue that occurs in most of all patients is of interest here. In order to make this measurable, the FAS questionnaire plays a special role, which should be completed by all 100 patients upon inclusion in the study and upon discharge from the rehabilitation clinic. In addition, the HADS-D questionnaire (Hospital Anxiety and Depression Scale) for self-assessment of depressive symptoms and anxiety symptoms and the SF-12 questionnaire (Short Form Health Survey) are used as a screening tool to assess health-related quality of life.
For the clinical examination of physical performance, the six-minute walk test, a body plethysmography and a long-term ECG are performed on recruited patients on admission and before discharge. In a three-month follow-up, all recruited patients should receive an FAS, HADS-D and SF-12 questionnaire to fill out. Some of these will also be called back to the clinic to check the development of lung function or performance, defined on the basis of VO2max, and will undergo an additional spiroergometric examination.
Thus, the effectiveness and effectiveness of the rehabilitation measures in patients under long-COVID is checked.
Detailed description
The study is a prospective, monocentric cohort study in which patients with the main diagnosis of long-COVID syndrome from the Paracelsus Harz Clinic, Bad Suderode, are included and followed up over a period of three months.
The study population consists of patients from the rehabilitation clinic Paracelsus-Harz-Klinik Bad Suderode. It is planned to enroll 100 patients, all of whom will be included in a three-month follow-up. Within this follow-up, 20 of the 100 patients will be selected to be re-examined in the clinic three months later. For this purpose, patients are selected who live within a maximum distance of 50km from the Paracelsus Harz Clinic and who are able to reach the clinic three months after completion of the rehabilitation measure.
After receiving the vote of the Ethics Committee of the Medical Association of the State of Saxony-Anhalt (Bad Suderode) and the written consent of the patients, socio-demographic information and questions are documented according to the standard of the rehabilitation clinic. All relevant baseline parameters (age, gender, BMI, drug treatment, etc.) are also documented. In order to obtain the essential values for the evaluation of the physical and psychological condition of the patients, all patients receive an FAS questionnaire, a HADS-D and an SF-12 questionnaire upon inclusion and at the end of the rehabilitation stay. Furthermore, after admission and before discharge, a six-minute walk test, a lung function test using body plethysmography and a long-term ECG for cardiological observation are carried out.
After the patients have left the clinic, 80 of the recruited patients will be contacted by post three months later in order to fill out the previously known questionnaires again. The Fatigue Questionnaire (FAS Questionnaire) is of particular interest for checking the physical and psychological development after completion of the rehabilitation treatment. In addition, the patients should again receive the HADS-D and SF-12 questionnaires to check their mental and physical well-being. If the patients cannot be reached, an attempt is made to obtain follow-up information by telephone, relatives or general practitioners. The remaining 20 patients will be referred to the clinic again as part of the three-month follow-up so that the development of lung function and performance, measured using VO2max, can be checked in the form of spiroergometry. During their stay, they also receive the FAS questionnaire, the HADS-D and the SF-12 questionnaire to fill out
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient with long/post-covid
Key inclusion criteria (1 listed)
- ≥ 18 years, written consent; inpatient stay in the participating rehabilitation clinic
Key exclusion criteria (1 listed)
- lack of consent, Illnesses or functional disorders which, in the opinion of the investigator, exclude participation in this clinical trial (dementia, psychotic disorders)
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 |
|---|---|---|
| questionnairesCompletion of 3 questionnaires (HADS; SF-12; FAS) at the beginning and end of the rehabilitation and after 3 months | Other | – |
Primary outcome
Course of fatigue symptoms measured with the FAS score
Time frame: Day one
Analysis of the questionnaires
Course of fatigue symptoms measured with the FAS score
Time frame: after 3 weeks
Analysis of the questionnaires
Course of fatigue symptoms measured with the FAS score
Time frame: after 3 Months
Analysis of the questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
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Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel Schlitt (+493948599784, axel.schlitt@pkd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of fatigue symptoms measured with the FAS score (time frame: Day one). The study lists 3 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 29 Mar 2023.