Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation

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]

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).

Study Overview

• Status: Completed
• Conditions: Post-COVID-19
• Intervention / Treatment: Behavioral: Multimodal pulmonary rehabilitation

• Study Type: Observational
• Enrollment (Actual): 779

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Weyer, Upper Austria, Austria, 3335
      • Rehabilitationszentrum Weyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Regular patients with post-COVID-19 Syndrome in inpatient rehabilitation.

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rehabilitation patients with post-COVID-19 Syndrome; This group includes rehabilitation patients with and without respiratory muscle training	Behavioral: Multimodal pulmonary rehabilitation; The rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)	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.	3 weeks of inpatient rehabilitation
Patient Health Questionnaire-4 (PHQ-4)	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.	3 weeks of inpatient rehabilitation
6-minute walk test	The 6-minute walk test is a standardized tool to assess functional exercise capacity operationalized by the walk distance.	3 weeks of inpatient rehabilitation

Collaborators and Investigators

• Sponsor: Pensionsversicherungsanstalt
• Investigators: Study Chair: David Felder, Mag., Pensionsversicherungsanstalt

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0009 Post-COVID

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