Covid19NCT04896905
Rehabilitation After Covid19-Clinical Results and Predictive Factors
An observational study of Covid19, run by Klinik Valens at 1 site in Switzerland.
Trial summary
The aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups: 1. SARS-CoV-2-positive patients in the isolation ward 2. Post-Covid-19 patients 3. Control group; matched for gender, age and co-morbidity Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Covid19
- What is being tested?
- Rehabilitation
- How many people
- 101 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2020to 18 May 2021
- How long will I take part?
- 4 Weeks
- 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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred to rehabilitation between March and June 2020 either with active Covid19, post-Covid-State oor other indications for inpatient rehab (eg. muskuloskelettal, cancer, pulmonary diseases not related to Covid19)
Who may be able to join
- Patients assigned to rehab
- Written informed consent
Who cannot join
- not able to fill in questionnaires in German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehabilitationszentrum Klinik Valens
Valens, Canton of St. Gallen, CH- 7317
About this study
Official title: Rehabilitation After Covid19-Clinical Results and Predictive Factors for Rehabilitation Outcomes
The aim of the study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups:
- SARS-CoV-2-positive patients in the isolation ward
- Post-Covid-19 patients
- Control group; matched for gender, age and co-morbidity
- Conditions
- Covid19
- Being tested
- Rehabilitation
- Keywords
- Covid19, Sars-CoV-2, Rehabilitation, Outcome, Predictive factors
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Rehabilitative procedures in isolation ward
| Study group | Role | What they receive |
|---|---|---|
| Isolation group with active Covid19 | Patients assigned to rehab which had to be treated in isolation wards dur to active disease Receives: Other: Rehabilitation | |
| Post-Covid-group | Patients assigned to rehab after active disease, still having restrictions in activity and particiaption Receives: Other: Rehabilitation | |
| Control group | Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Timed Up and Go-Test TUG (Seconds; less=better, normal <10 Sec.)
Measured: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Functional Independence Measurement-Level (FIM)
FIM at entry and discharge (min 18, max 126 points; higher level= better functioning; )
Measured: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Promis-10 (Promis= Patient reported outcome measurement information system)
Level of patient self rated functioning in daily activities (higher level= better self related functioning)
Measured: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Quality of life
EQ5D- VAS (0-100; higher level = better quality of life)
Measured: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Oct 2020
- Primary completion28 Feb 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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-control
- Time perspective
- Other
- Enrolment
- 101 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Bachmann, Klinik Valens
- Investigators
- Steffi Petzold, MMed, Principal investigator, Kliniken ValensRoisin Carney, PT, cand MSc, Principal investigator, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896905
- Sponsor's protocol ID
- Covid19_2020
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Covid19-Clinical Results and Predictive Factors for Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT04896905
- Acronym / sponsor ID
- Covid19_2020
- Conditions
- Covid19
- Keywords
- Covid19, Sars-CoV-2, Rehabilitation, Outcome, Predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 21 May 2021 (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 study is to gain insight into the rehabilitation process and predictive factors for the outcome after rehabilitation in three patient groups:
- SARS-CoV-2-positive patients in the isolation ward
- Post-Covid-19 patients
- Control group; matched for gender, age and co-morbidity
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isolation group with active Covid19 | – | Other: RehabilitationPatients assigned to rehab which had to be treated in isolation wards dur to active disease |
| Post-Covid-group | – | Other: RehabilitationPatients assigned to rehab after active disease, still having restrictions in activity and particiaption |
| Control group | – | Other: RehabilitationPateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to rehabilitation between March and June 2020 either with active Covid19, post-Covid-State oor other indications for inpatient rehab (eg. muskuloskelettal, cancer, pulmonary diseases not related to Covid19)
Key inclusion criteria (2 listed)
- Patients assigned to rehab
- Written informed consent
Key exclusion criteria (1 listed)
- not able to fill in questionnaires in German
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 |
|---|---|---|
| RehabilitationRehabilitative procedures in isolation ward | Other | Control group, Isolation group with active Covid19, Post-Covid-group |
Primary outcome
Mobility
Time frame: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Timed Up and Go-Test TUG (Seconds; less=better, normal <10 Sec.)
Functional Independence Measurement-Level (FIM)
Time frame: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
FIM at entry and discharge (min 18, max 126 points; higher level= better functioning; )
Promis-10 (Promis= Patient reported outcome measurement information system)
Time frame: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
Level of patient self rated functioning in daily activities (higher level= better self related functioning)
Quality of life
Time frame: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
EQ5D- VAS (0-100; higher level = better quality of life)
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 21 May 2021.
- 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.
Steffi Petzold, MMed principal investigator
Kliniken Valens
Roisin Carney, PT, cand MSc principal investigator
Kliniken Valens
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 Covid19, run by Klinik Valens 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 2 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 21 May 2021. 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?
Mobility (time frame: Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)). The study lists 4 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 21 May 2021.