Post-COVID-19NCT05496842
Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation
An observational study of Post-COVID-19, run by Pensionsversicherungsanstalt at 1 site in Austria.
Trial summary
The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-COVID-19
- What is being tested?
- Multimodal pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 779 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2020to 28 Feb 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Regular patients with post-COVID-19 Syndrome in inpatient rehabilitation.
Who may be able to join
- The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Veränderungen ausgewählter Funktions- Und Teilhabebezogener Merkmale Bei Post-COVID-Patient*Innen in Folge Einer Pneumologischen Phase II Rehabilitation [Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation]
The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength).
The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).
- Conditions
- Post-COVID-19
- Being tested
- Multimodal pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal pulmonary rehabilitationBehavioural
The rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation patients with post-COVID-19 Syndrome | This group includes rehabilitation patients with and without respiratory muscle training Receives: Behavioral: Multimodal pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
The 6-minute walk test is a standardized tool to assess functional exercise capacity operationalized by the walk distance.
Measured: 3 weeks of inpatient rehabilitation
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions.
Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health.
Measured: 3 weeks of inpatient rehabilitation
Patient Health Questionnaire-4 (PHQ-4)
The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.
Measured: 3 weeks of inpatient rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Oct 2020
- Primary completion31 Jan 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pensionsversicherungsanstalt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Felder, Mag., Study chair, Pensionsversicherungsanstalt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496842
- Sponsor's protocol ID
- 0009 Post-COVID
- Status last verified
- Mar 2023
- First submitted
- 9 Aug 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veränderungen ausgewählter Funktions- Und Teilhabebezogener Merkmale Bei Post-COVID-Patient*Innen in Folge Einer Pneumologischen Phase II Rehabilitation [Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation]
- ClinicalTrials.gov ID
- NCT05496842
- Acronym / sponsor ID
- 0009 Post-COVID
- Conditions
- Post-COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- PensionsversicherungsanstaltUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Aug 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 this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength).
The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation patients with post-COVID-19 Syndrome | – | Behavioral: Multimodal pulmonary rehabilitationThis group includes rehabilitation patients with and without respiratory muscle training |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Regular patients with post-COVID-19 Syndrome in inpatient rehabilitation.
Key inclusion criteria (1 listed)
- The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Multimodal pulmonary rehabilitationThe rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients. | Behavioural | Rehabilitation patients with post-COVID-19 Syndrome |
Primary outcome
6-minute walk test
Time frame: 3 weeks of inpatient rehabilitation
The 6-minute walk test is a standardized tool to assess functional exercise capacity operationalized by the walk distance.
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
Time frame: 3 weeks of inpatient rehabilitation
The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions. Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health.
Patient Health Questionnaire-4 (PHQ-4)
Time frame: 3 weeks of inpatient rehabilitation
The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.
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 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
David Felder, Mag. study chair
Pensionsversicherungsanstalt
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 Post-COVID-19, run by Pensionsversicherungsanstalt at 1 site in Austria.
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: finished, as of the sponsor's last update on 28 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 Austria. 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?
6-minute walk test (time frame: 3 weeks of inpatient rehabilitation). 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 28 Mar 2023.