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).

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Key information

Conditions

Post-COVID-19

Sex eligibility

All sexes

Study type

Observational

Primary location

Rehabilitationszentrum Weyer

Weyer, Upper Austria, 3335, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal pulmonary rehabilitation

Behavioral

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.

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Pensionsversicherungsanstalt

Other

Registry information

Official study title

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]

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Aug 11, 2022
Registry last updated: Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed