- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04896905
Rehabilitation After Covid19-Clinical Results and Predictive Factors
May 20, 2021 updated by: Stefan Bachmann, Klinik Valens
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
Study Overview
Study Type
Observational
Enrollment (Actual)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SG
-
Valens, SG, Switzerland, CH- 7317
- Rehabilitationszentrum Klinik Valens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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)
Description
Inclusion Criteria:
- Patients assigned to rehab
- Written informed consent
Exclusion Criteria:
- not able to fill in questionnaires in German
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Isolation group with active Covid19
Patients assigned to rehab which had to be treated in isolation wards dur to active disease
|
Rehabilitative procedures in isolation ward
|
|
Post-Covid-group
Patients assigned to rehab after active disease, still having restrictions in activity and particiaption
|
Rehabilitative procedures in isolation ward
|
|
Control group
Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection
|
Rehabilitative procedures in isolation ward
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.)
|
Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
|
|
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; )
|
Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
|
|
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)
|
Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
|
|
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)
|
Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steffi Petzold, MMed, Kliniken Valens
- Principal Investigator: Roisin Carney, PT, cand MSc, Kliniken Valens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
May 18, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 21, 2021
Study Record Updates
Last Update Posted (Actual)
May 21, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Covid19_2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.