Rehabilitation After Covid19-Clinical Results and Predictive Factors

• Sponsor: Klinik Valens (Other)
• Overall Status: Completed
• CT.gov ID: NCT04896905
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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. SARS-CoV-2-positive patients in the isolation ward

2. Post-Covid-19 patients

3. Control group; matched for gender, age and co-morbidity

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Rehabilitation

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 101 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Rehabilitation After Covid19-Clinical Results and Predictive Factors for Rehabilitation Outcomes
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Isolation group with active Covid19 Patients assigned to rehab which had to be treated in isolation wards dur to active disease	Other: Rehabilitation; Rehabilitative procedures in isolation ward
Post-Covid-group Patients assigned to rehab after active disease, still having restrictions in activity and particiaption	Other: Rehabilitation; Rehabilitative procedures in isolation ward
Control group Pateints assigned to rehabilitation in the same time period without any signs of Sars-coV-2 infection	Other: Rehabilitation; Rehabilitative procedures in isolation ward

Outcome Measures

Primary Outcome Measures

1. Mobility [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.)

2. Functional Independence Measurement-Level (FIM) [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; )

3. Promis-10 (Promis= Patient reported outcome measurement information system) [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)

4. Quality of life [Measurements done at entry and at discharge of rehabilitation (time between: 4- 6 weeks)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients assigned to rehab

• Written informed consent

Exclusion Criteria:

• not able to fill in questionnaires in German

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitationszentrum Klinik Valens	Valens	SG	Switzerland	CH- 7317

Sponsors and Collaborators

• Klinik Valens

Investigators

• Principal Investigator: Steffi Petzold, MMed, Kliniken Valens
• Principal Investigator: Roisin Carney, PT, cand MSc, Kliniken Valens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefan Bachmann, Chief Medical Officer, Clinical Professor, Klinik Valens
• ClinicalTrials.gov Identifier: NCT04896905
• Other Study ID Numbers: Covid19_2020
• First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefan Bachmann, Chief Medical Officer, Clinical Professor, Klinik Valens: Covid19; Sars-CoV-2; Rehabilitation; Outcome; Predictive factors
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 21, 2021