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Clinical Trials/NCT05496842
NCT05496842
Completed
Not Applicable

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]

Pensionsversicherungsanstalt1 site in 1 country779 target enrollmentOctober 1, 2020
ConditionsPost-COVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-COVID-19
Sponsor
Pensionsversicherungsanstalt
Enrollment
779
Locations
1
Primary Endpoint
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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. 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).

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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