NCT04896905

Brief 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. 1.SARS-CoV-2-positive patients in the isolation ward
  2. 2.Post-Covid-19 patients
  3. 3.Control group; matched for gender, age and co-morbidity

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

May 19, 2021

Last Update Submit

May 20, 2021

Conditions

Keywords

Covid19Sars-CoV-2RehabilitationOutcomePredictive factors

Outcome Measures

Primary Outcomes (4)

  • Mobility

    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)

    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)

    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

    EQ5D- VAS (0-100; higher level = better quality of life)

    Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)

Study Arms (3)

Isolation group with active Covid19

Patients assigned to rehab which had to be treated in isolation wards dur to active disease

Other: Rehabilitation

Post-Covid-group

Patients assigned to rehab after active disease, still having restrictions in activity and particiaption

Other: Rehabilitation

Control group

Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection

Other: Rehabilitation

Interventions

Rehabilitative procedures in isolation ward

Control groupIsolation group with active Covid19Post-Covid-group

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • Patients assigned to rehab
  • Written informed consent

You may not qualify if:

  • not able to fill in questionnaires in German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitationszentrum Klinik Valens

Valens, Canton of St. Gallen, CH- 7317, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Steffi Petzold, MMed

    Kliniken Valens

    PRINCIPAL INVESTIGATOR
  • Roisin Carney, PT, cand MSc

    Kliniken Valens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer, Clinical Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 21, 2021

Study Start

October 1, 2020

Primary Completion

February 28, 2021

Study Completion

May 18, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations